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. 2021 Nov 11;11(11):CD001145.
doi: 10.1002/14651858.CD001145.pub5.

Late (≥ 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants

Lex W Doyle  1   2   3   4 , Jeanie L Cheong  1   2   4 , Susanne Hay  5 , Brett J Manley  1   4 , Henry L Halliday  6
Affiliations

Late (≥ 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants

Lex W Doyle et al. Cochrane Database Syst Rev. .

Abstract

Background: Many infants born preterm develop bronchopulmonary dysplasia (BPD), with lung inflammation playing a role. Corticosteroids have powerful anti-inflammatory effects and have been used to treat individuals with established BPD. However, it is unclear whether any beneficial effects outweigh the adverse effects of these drugs.

Objectives: To examine the relative benefits and adverse effects of late (starting at seven or more days after birth) systemic postnatal corticosteroid treatment for preterm infants with evolving or established BPD.

Search methods: We ran an updated search on 25 September 2020 of the following databases: CENTRAL via CRS Web and MEDLINE via OVID. We also searched clinical trials databases and reference lists of retrieved articles for randomised controlled trials (RCTs). We did not include quasi-RCTs.

Selection criteria: We selected for inclusion in this review RCTs comparing systemic (intravenous or oral) postnatal corticosteroid treatment versus placebo or no treatment started at seven or more days after birth for preterm infants with evolving or established BPD. We did not include trials of inhaled corticosteroids.

Data collection and analysis: We used standard Cochrane methods. We extracted and analysed data regarding clinical outcomes that included mortality, BPD, and cerebral palsy. We used the GRADE approach to assess the certainty of evidence.

Main results: Use of the GRADE approach revealed that the certainty of evidence was high for most of the major outcomes considered, except for BPD at 36 weeks for all studies combined and for the dexamethasone subgroup, which were downgraded one level to moderate because of evidence of publication bias, and for the combined outcome of mortality or BPD at 36 weeks for all studies combined and for the dexamethasone subgroup, which were downgraded one level to moderate because of evidence of substantial heterogeneity. We included 23 RCTs (1817 infants); 21 RCTS (1382 infants) involved dexamethasone (one also included hydrocortisone) and two RCTs (435 infants) involved hydrocortisone only. The overall risk of bias of included studies was low; all were RCTs and most trials used rigorous methods. Late systemic corticosteroids overall reduce mortality to the latest reported age (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.66 to 0.99; 21 studies, 1428 infants; high-certainty evidence). Within the subgroups by drug, neither dexamethasone (RR 0.85, 95% CI 0.66 to 1.11; 19 studies, 993 infants; high-certainty evidence) nor hydrocortisone (RR 0.74, 95% CI 0.54 to 1.02; 2 studies, 435 infants; high-certainty evidence) alone clearly reduce mortality to the latest reported age. We found little evidence for statistical heterogeneity between the dexamethasone and hydrocortisone subgroups (P = 0.51 for subgroup interaction). Late systemic corticosteroids overall probably reduce BPD at 36 weeks' postmenstrual age (PMA) (RR 0.89, 95% CI 0.80 to 0.99; 14 studies, 988 infants; moderate-certainty evidence). Dexamethasone probably reduces BPD at 36 weeks' PMA (RR 0.76, 95% CI 0.66 to 0.87; 12 studies, 553 infants; moderate-certainty evidence), but hydrocortisone does not (RR 1.10, 95% CI 0.92 to 1.31; 2 studies, 435 infants; high-certainty evidence) (P < 0.001 for subgroup interaction). Late systemic corticosteroids overall probably reduce the combined outcome of mortality or BPD at 36 weeks' PMA (RR 0.85, 95% CI 0.79 to 0.92; 14 studies, 988 infants; moderate-certainty evidence). Dexamethasone probably reduces the combined outcome of mortality or BPD at 36 weeks' PMA (RR 0.75, 95% CI 0.67 to 0.84; 12 studies, 553 infants; moderate-certainty evidence), but hydrocortisone does not (RR 0.98, 95% CI 0.88 to 1.09; 2 studies, 435 infants; high-certainty evidence) (P < 0.001 for subgroup interaction). Late systemic corticosteroids overall have little to no effect on cerebral palsy (RR 1.17, 95% CI 0.84 to 1.61; 17 studies, 1290 infants; high-certainty evidence). We found little evidence for statistical heterogeneity between the dexamethasone and hydrocortisone subgroups (P = 0.63 for subgroup interaction). Late systemic corticosteroids overall have little to no effect on the combined outcome of mortality or cerebral palsy (RR 0.90, 95% CI 0.76 to 1.06; 17 studies, 1290 infants; high-certainty evidence). We found little evidence for statistical heterogeneity between the dexamethasone and hydrocortisone subgroups (P = 0.42 for subgroup interaction). Studies had few participants who were not intubated at enrolment; hence, it is not possible to make any meaningful comments on the effectiveness of late corticosteroids in preventing BPD in non-intubated infants, including those who might in the present day be supported by non-invasive techniques such as nasal continuous positive airway pressure or high-flow nasal cannula oxygen/air mixture, but who might still be at high risk of later BPD. Results of two ongoing studies are awaited.

Authors' conclusions: Late systemic postnatal corticosteroid treatment (started at seven days or more after birth) reduces the risks of mortality and BPD, and the combined outcome of mortality or BPD, without evidence of increased cerebral palsy. However, the methodological quality of studies determining long-term outcomes is limited, and no studies were powered to detect increased rates of important adverse long-term neurodevelopmental outcomes. This review supports the use of late systemic corticosteroids for infants who cannot be weaned from mechanical ventilation. The role of late systemic corticosteroids for infants who are not intubated is unclear and needs further investigation. Longer-term follow-up into late childhood is vital for assessment of important outcomes that cannot be assessed in early childhood, such as effects of late systemic corticosteroid treatment on higher-order neurological functions, including cognitive function, executive function, academic performance, behaviour, mental health, motor function, and lung function. Further RCTs of late systemic corticosteroids should include longer-term survival free of neurodevelopmental disability as the primary outcome.

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Conflict of interest statement

Lex Doyle's institution received Centre of Research Excellence grant funding from the National Health and Medical Research Council (NHMRC) of Australia. He was Chief Investigator of the DART study, a randomised controlled trial of low‐dose, short‐course dexamethasone in ventilator‐dependent infants (Doyle 2006). This study was funded by the NHMRC of Australia.

Jeanie Cheong received a Career Development Fellowship, for salary support, from the Australian Medical Research Future Fund.

Susanne Hay was the PI on a network meta‐analysis of systemic corticosteroids for bronchopulmonary dysplasia, for which her institution received a grant from the Deborah Munroe Noonan Memorial Research Fund. She works as a neonatologist at Beth Israel Deaconess Medical Center.

Brett Manley's institution received funding for a Career Development Fellowship from the Australian Medical Research Future Fund. His institution also received project grant funding from the NHMRC of Australia. He has published articles and review articles on the topic of postnatal steroids in peer‐reviewed journals, and has commented on social media. He works as a Consultant Neonatologist at The Royal Women's Hospital, in Parkville, Victoria, Australia.

Henry Halliday is Joint Editor of Neonatology.

Data from Doyle 2006 were extracted by HLH and Richard Ehrenkranz (deceased).

Figures

1
1
Study flow diagram: review update.
2
2
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of comparison: 1 Mortality, outcome: 1.4 Mortality at latest reported age.
5
5
Funnel plot of comparison: 2 Bronchopulmonary dysplasia (BPD), outcome: 2.2 BPD at 36 weeks' postmenstrual age.
6
6
Funnel plot of comparison: 3 Mortality or BPD, outcome: 3.2 Mortality or BPD at 36 weeks' postmenstrual age.
7
7
Funnel plot of comparison: 6 Long‐term follow‐up, outcome: 6.10 Cerebral palsy at latest reported age.
8
8
Funnel plot of comparison: 6 Long‐term follow‐up, outcome: 6.14 Mortality or cerebral palsy at latest reported age.
1.1
1.1. Analysis
Comparison 1: Mortality at different ages, Outcome 1: Neonatal mortality before 28 days after birth
1.2
1.2. Analysis
Comparison 1: Mortality at different ages, Outcome 2: Mortality at 36 weeks' postmenstrual age
1.3
1.3. Analysis
Comparison 1: Mortality at different ages, Outcome 3: Mortality to hospital discharge
1.4
1.4. Analysis
Comparison 1: Mortality at different ages, Outcome 4: Mortality at latest reported age
2.1
2.1. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD), Outcome 1: BPD at 28 days after birth
2.2
2.2. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD), Outcome 2: BPD at 36 weeks' postmenstrual age
2.3
2.3. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD), Outcome 3: BPD at 36 weeks in survivors
2.4
2.4. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD), Outcome 4: Late rescue with corticosteroids
2.5
2.5. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD), Outcome 5: Home on oxygen
2.6
2.6. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD), Outcome 6: Survivors discharged home on oxygen
3.1
3.1. Analysis
Comparison 3: Mortality or BPD, Outcome 1: Mortality or BPD at 28 days after birth
3.2
3.2. Analysis
Comparison 3: Mortality or BPD, Outcome 2: Mortality or BPD at 36 weeks' postmenstrual age
4.1
4.1. Analysis
Comparison 4: Failure to extubate, Outcome 1: Failure to extubate by 3rd day after treatment
4.2
4.2. Analysis
Comparison 4: Failure to extubate, Outcome 2: Failure to extubate by 7th day after treatment
4.3
4.3. Analysis
Comparison 4: Failure to extubate, Outcome 3: Failure to extubate by 14th day after treatment
4.4
4.4. Analysis
Comparison 4: Failure to extubate, Outcome 4: Failure to extubate by 28th day after treatment
5.1
5.1. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 1: Infection
5.2
5.2. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 2: Hyperglycaemia
5.3
5.3. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 3: Glycosuria
5.4
5.4. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 4: Hypertension
5.5
5.5. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 5: New cranial echodensities
5.6
5.6. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 6: Necrotising enterocolitis (NEC)
5.7
5.7. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 7: Gastrointestinal bleeding
5.8
5.8. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 8: Gastrointestinal perforation
5.9
5.9. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 9: Severe retinopathy of prematurity (ROP)
5.10
5.10. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 10: Severe ROP in survivors
5.11
5.11. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 11: Hypertrophic cardiomyopathy
5.12
5.12. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 12: Pneumothorax
5.13
5.13. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 13: Severe intraventricular haemorrhage (IVH)
5.14
5.14. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 14: Cystic periventricular leukomalacia
6.1
6.1. Analysis
Comparison 6: Long‐term follow‐up, Outcome 1: Bayley Mental Developmental Index (MDI) < ‐2 SD
6.2
6.2. Analysis
Comparison 6: Long‐term follow‐up, Outcome 2: Bayley MDI < ‐2 SD in survivors tested
6.3
6.3. Analysis
Comparison 6: Long‐term follow‐up, Outcome 3: Bayley Psychomotor Developmental Index (PDI) < ‐2 SD
6.4
6.4. Analysis
Comparison 6: Long‐term follow‐up, Outcome 4: Bayley PDI < ‐2 SD in survivors tested
6.5
6.5. Analysis
Comparison 6: Long‐term follow‐up, Outcome 5: Blindness
6.6
6.6. Analysis
Comparison 6: Long‐term follow‐up, Outcome 6: Blindness in survivors assessed
6.7
6.7. Analysis
Comparison 6: Long‐term follow‐up, Outcome 7: Deafness
6.8
6.8. Analysis
Comparison 6: Long‐term follow‐up, Outcome 8: Deafness in survivors assessed
6.9
6.9. Analysis
Comparison 6: Long‐term follow‐up, Outcome 9: Cerebral palsy at 1 to 3 years of age
6.10
6.10. Analysis
Comparison 6: Long‐term follow‐up, Outcome 10: Cerebral palsy at latest reported age
6.11
6.11. Analysis
Comparison 6: Long‐term follow‐up, Outcome 11: Mortality before follow‐up in trials assessing cerebral palsy at 1‐3 years of age
6.12
6.12. Analysis
Comparison 6: Long‐term follow‐up, Outcome 12: Mortality before follow‐up in trials assessing cerebral palsy at latest reported age
6.13
6.13. Analysis
Comparison 6: Long‐term follow‐up, Outcome 13: Mortality or cerebral palsy at 1 to 3 years
6.14
6.14. Analysis
Comparison 6: Long‐term follow‐up, Outcome 14: Mortality or cerebral palsy at latest reported age
6.15
6.15. Analysis
Comparison 6: Long‐term follow‐up, Outcome 15: Cerebral palsy in survivors assessed at 1‐3 years of age
6.16
6.16. Analysis
Comparison 6: Long‐term follow‐up, Outcome 16: Cerebral palsy in survivors assessed at latest age
6.17
6.17. Analysis
Comparison 6: Long‐term follow‐up, Outcome 17: Major neurosensory disability (variable criteria ‐ see individual studies)
6.18
6.18. Analysis
Comparison 6: Long‐term follow‐up, Outcome 18: Mortality before follow‐up in trials assessing major neurosensory disability (variable criteria)
6.19
6.19. Analysis
Comparison 6: Long‐term follow‐up, Outcome 19: Mortality or major neurosensory disability (variable criteria)
6.20
6.20. Analysis
Comparison 6: Long‐term follow‐up, Outcome 20: Major neurosensory disability (variable criteria) in survivors assessed
6.21
6.21. Analysis
Comparison 6: Long‐term follow‐up, Outcome 21: Abnormal neurological exam (variable criteria ‐ see individual studies)
6.22
6.22. Analysis
Comparison 6: Long‐term follow‐up, Outcome 22: Mortality before follow‐up in trials assessing abnormal neurological exam (variable criteria)
6.23
6.23. Analysis
Comparison 6: Long‐term follow‐up, Outcome 23: Mortality or abnormal neurological exam (variable criteria)
6.24
6.24. Analysis
Comparison 6: Long‐term follow‐up, Outcome 24: Abnormal neurological exam (variable criteria) in survivors assessed
6.25
6.25. Analysis
Comparison 6: Long‐term follow‐up, Outcome 25: Re‐hospitalisation
6.26
6.26. Analysis
Comparison 6: Long‐term follow‐up, Outcome 26: Re‐hospitalisation in survivors seen at follow‐up
7.1
7.1. Analysis
Comparison 7: Later childhood outcomes, Outcome 1: Recurrent wheezing in survivors examined at 5 years
7.2
7.2. Analysis
Comparison 7: Later childhood outcomes, Outcome 2: Use of corrective lenses in survivors examined at 5 years
7.3
7.3. Analysis
Comparison 7: Later childhood outcomes, Outcome 3: Use of physical therapy in survivors examined at 5 years
7.4
7.4. Analysis
Comparison 7: Later childhood outcomes, Outcome 4: Use of speech therapy in survivors examined at 5 years
7.5
7.5. Analysis
Comparison 7: Later childhood outcomes, Outcome 5: Intellectual impairment in survivors tested at 5 or more years
7.6
7.6. Analysis
Comparison 7: Later childhood outcomes, Outcome 6: IQ
8.1
8.1. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 1: Asthma in survivors assessed
8.2
8.2. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 2: Forced expired volume in 1 second < ‐2 SD
8.3
8.3. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 3: Forced expired volume in 1 second ‐ z‐score
8.4
8.4. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 4: Forced expired volume in 1 second ‐ % predicted
8.5
8.5. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 5: Forced expired volume in 1 second ‐ standardised mean difference
8.6
8.6. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 6: Forced vital capacity ‐ z‐score
8.7
8.7. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 7: Forced vital capacity ‐ % predicted
8.8
8.8. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 8: Forced vital capacity ‐ standardised mean difference
8.9
8.9. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 9: FEV₁/FVC %
8.10
8.10. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 10: FEV₁/FVC < ‐2 SD
8.11
8.11. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 11: FEF25% -75% ‐ % predicted
8.12
8.12. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 12: Positive bronchodilator response
8.13
8.13. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 13: Forced vital capacity < ‐2 SD
8.14
8.14. Analysis
Comparison 8: Respiratory outcomes in childhood ‐ after 5 years, Outcome 14: Exercise‐induced bronchoconstriction
9.1
9.1. Analysis
Comparison 9: Growth in childhood, Outcome 1: Height ‐ z‐score
9.2
9.2. Analysis
Comparison 9: Growth in childhood, Outcome 2: Height < ‐2 SD
9.3
9.3. Analysis
Comparison 9: Growth in childhood, Outcome 3: Weight ‐ z‐score
9.4
9.4. Analysis
Comparison 9: Growth in childhood, Outcome 4: Weight < ‐2 SD
9.5
9.5. Analysis
Comparison 9: Growth in childhood, Outcome 5: Body mass index (BMI) ‐ z‐score
9.6
9.6. Analysis
Comparison 9: Growth in childhood, Outcome 6: BMI < ‐2 SD
10.1
10.1. Analysis
Comparison 10: Blood pressure in childhood, Outcome 1: Systolic blood pressure > 95th centile
10.2
10.2. Analysis
Comparison 10: Blood pressure in childhood, Outcome 2: Systolic blood pressure z‐score
10.3
10.3. Analysis
Comparison 10: Blood pressure in childhood, Outcome 3: Diastolic blood pressure > 95th centile
10.4
10.4. Analysis
Comparison 10: Blood pressure in childhood, Outcome 4: Diastolic blood pressure z‐score
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Update of

References

References to studies included in this review

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    1. Onland W, Cools F, Kroon A, Rademaker K, Merkus MP, Dijk PH, et al, Stop-BPD Study Group. Effect of hydrocortisone therapy initiated 7 to 14 days after birth on mortality or bronchopulmonary dysplasia among very preterm infants receiving mechanical ventilation: a randomized clinical trial. JAMA 2019;321(4):354-63. [DOI: 10.1001/jama.2018.21443] [PMID: ] - DOI - PMC - PubMed
Papile 1998 {published data only}
    1. Papile LA, Tyson JE, Stoll BJ, Wright LL, Donovan EF, Bauer CR, et al. A multicenter trial of two dexamethasone regimens in ventilator-dependent premature infants. New England Journal of Medicine 1998;338(16):1112-8. [DOI: 10.1056/NEJM199804163381604] [PMID: ] - DOI - PubMed
    1. Stoll BJ, Temprosa M, Tyson JE, Papile LA, Wright LL, Bauer CR, et al. Dexamethasone therapy increases infection in low birth weight infants. Pediatrics 1999;104(5):e63. [DOI: 10.1542/peds.104.5.e63] [PMID: ] - DOI - PubMed
Parikh 2013 {published data only}
    1. Parikh NA, Kennedy KA, Lasky RE, McDavid GE, Tyson JE. Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes. Journal of Pediatrics 2013;162(4):685-90. [DOI: 10.1016/j.jpeds.2012.09.054] [PMID: ] - DOI - PMC - PubMed
    1. Parikh NA, Kennedy KA, Lasky RE, Tyson JE. Neurodevelopmental outcomes of extremely preterm infants randomized to stress dose hydrocortisone. PLoS One 2015;10(9):e0137051. [DOI: 10.1371/journal.pone.0137051] [PMID: ] - DOI - PMC - PubMed
Romagnoli 1997 {published data only}
    1. Romagnoli C, Vento G, Zecca E, Papacci P, De Carolis MP, Maggio L, et al. Dexamethasone for the prevention of chronic lung disease in preterm neonates: a prospective randomized study [II desametazone nella prevenzione della patologia polmonare cronica del neonato pretermine: studio prospettico randomizzato]. Rivista Italiana di Pediatria [Italian Journal of Pediatrics] 1997;24:283-8. [ISSN: 0392-5161]
    1. Romagnoli C, Zecca E, Luciano R, Torrioli G, Tortorolo G. A three year follow-up of preterm infants after moderately early treatment with dexamethasone. Archives of Disease in Childhood. Fetal and Neonatal Edition 2002;87(1):F55-8. [DOI: 10.1136/fn.87.1.f55] [PMID: ] - DOI - PMC - PubMed
    1. Romagnoli C, Zecca E, Vento G, Maggio L, Papacci P, Tortorolo G. Effect on growth of two different dexamethasone courses for preterm infants at risk of chronic lung disease. Pharmacology 1999;59(5):266-74. [10.1159/000028329] [PMID: ] - PubMed
Scott 1997 {published data only}
    1. Scott SM, Backstrom C, Bessman S. Effect of five days of dexamethasone therapy on ventilator dependence and adrenocorticotropic hormone-stimulated cortisol concentrations. Journal of Perinatology 1997;17(1):24-8. [PMID: ] - PubMed
Vento 2004 {published data only}
    1. Vento G, Matassa PG, Zecca E, Tortorolo L, Martelli M, De Carolis MP, et al. Effect of dexamethasone on tracheobronchial aspirate fluid cytology and pulmonary mechanics in preterm infants. Pharmacology 2004;71(3):113-9. [DOI: 10.1159/000077444] [PMID: ] - DOI - PubMed
    1. Vento G. Personal communication. email 2012.
Vincer 1998 {published data only}
    1. Vincer MJ, Allen AC. Double blind randomized controlled trial of 6-day pulse of dexamethasone for very low birth weight infants (VLBW < 1500 grams) who are ventilator dependent at 4 weeks of age. Pediatric Research 1998;43:201A. [CENTRAL: CN-00295187]
    1. Vincer MJ. Personal communication. email 2002.
Walther 2003 {published data only}
    1. Walther F. Personal communication. email 2012.
    1. Walther FJ, Findlay RD, Durand M. Adrenal suppression and extubation rate after moderately early low-dose dexamethasone therapy in very preterm infants. Early Human Development 2003;74(1):37-45. [DOI: 10.1016/s0378-3782(03)00082-3] [PMID: ] - DOI - PubMed
Yates 2019 {published data only}
    1. Yates H, Chiocchia V, Linsell L, Orsi N, Juszczak E, Johnson K, et al. Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. Southampton (UK): NIHR Journals Library, 2019. [DOI: 10.3310/eme06080] [ISSN: 2050-4365; 2050-4373] [PMID: ] - DOI - PubMed

References to studies excluded from this review

Anttila 2005 {published data only}
    1. Anttila E, Peltoniemi O, Haumont D, Herting E, ter Horst H, Heinonen K, et al. Early neonatal dexamethasone treatment for prevention of bronchopulmonary dysplasia. Randomised trial and meta-analysis evaluating the duration of dexamethasone therapy. European Journal of Pediatrics 2005;164(8):472-81. [DOI: 10.1007/s00431-005-1645-8] [PMID: ] - DOI - PubMed
Armstrong 2002 {published data only}
    1. Armstrong DL, Penrice J, Bloomfield FH, Knight DB, Dezoete JA, Harding JE. Follow up of a randomised trial of two different courses of dexamethasone for preterm babies at risk of chronic lung disease. Archives of Disease of Childhood. Fetal and Neonatal Edition 2002;86(2):F102-7. [DOI: 10.1136/fn.86.2.f102] [PMID: ] - DOI - PMC - PubMed
Ashton 1994 {published data only}
    1. Ashton MR, Postle AD, Smith DE, Hall MA. Surfactant phosphatidylcholine composition during dexamethasone treatment in chronic lung disease. Archives of Disease of Childhood. Fetal and Neonatal Edition 1994;71(2):F114-7. [DOI: 10.1136/fn.71.2.f114] [PMID: ] - DOI - PMC - PubMed
Baden 1972 {published data only}
    1. Baden M, Bauer CR, Colle E, Klein G, Taeusch HW Jr, Stern L. A controlled trial of hydrocortisone therapy in infants with respiratory distress syndrome. Pediatrics 1972;50(4):526-34. [PMID: ] - PubMed
    1. Fitzhardinge PM, Eisen A, Lejtenyi C, Metrakos K, Ramsay M. Sequelae of early steroid administration to the newborn infant. Pediatrics 1974;53(6):877-83. [PMID: ] - PubMed
Batton 2012 {published data only}
    1. Batton BJ, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, et al, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Feasibility study of early blood pressure management in extremely preterm infants. Journal of Pediatrics 2012;161(1):65-9.e1. [DOI: 10.1016/j.jpeds.2012.01.014] [PMID: ] - DOI - PMC - PubMed
Baud 2016 {published data only}
    1. Baud O, Maury L, Lebail F, Ramful D, El Moussawi F, Nicaise C, et al, Premiloc Trial Study Group. Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial. Lancet 2016;387(10030):1827-36. [DOI: S0140-6736(16)00202-6 [pii]] [PMID: ] - PubMed
Biswas 2003 {published data only}
    1. Biswas S, Buffery J, Enoch H, Bland M, Markiewicz M, Walters D. Pulmonary effects of triiodothyronine (T3) and hydrocortisone (HC) supplementation in preterm infants less than 30 weeks' gestation: results of the THORN trial - thyroid hormone replacement in neonates. Pediatric Research 2003;53(1):48-56. [DOI: 10.1203/00006450-200301000-00011] [PMID: ] - DOI - PubMed
Bloomfield 1998 {published data only}
    1. Bloomfield FH, Knight DB, Harding JE. Side effects of 2 different dexamethasone courses for preterm infants at risk of chronic lung disease: a randomized trial. Journal of Pediatrics 1998;133(3):395-400. [DOI: 10.1016/s0022-3476(98)70277-x] [PMID: ] - DOI - PubMed
Bonsante 2007 {published data only}
    1. Bonsante F, Latorre G, Iacobelli S, Forziati V, Laforgia N, Esposito L, et al. Early low-dose hydrocortisone in very preterm infants: a randomized, placebo-controlled trial. Neonatology 2007;91(4):217-21. [DOI: 10.1159/000098168] [PMID: ] - DOI - PubMed
Couser 1992 {published data only}
    1. Couser RJ, Ferrara TB, Falde B, Johnson K, Schilling CG, Hoekstra RE. Effectiveness of dexamethasone in preventing extubation failure in preterm infants at increased risk for airway edema. Journal of Pediatrics 1992;121(4):591-6. [DOI: 10.1016/s0022-3476(05)81154-0] [PMID: ] - DOI - PubMed
Cranefield 2004 {published data only}
    1. Cranefield DJ, Odd DE, Harding JE, Teele RL. High incidence of nephrocalcinosis in extremely preterm infants treated with dexamethasone. Pediatric Radiology 2004;34(2):1090-7. [DOI: 10.1007/s00247-003-1090-7] [PMID: ] - DOI - PubMed
Durand 2002 {published data only}
    1. Durand M, Mendoza MW, Tantivit P, Kugelman A, McEvoy C. A randomized trial of moderately early low-dose dexamethasone therapy in very low birth weight infants: dynamic pulmonary mechanics, oxygenation, and ventilation. Pediatrics 2002;109(2):262-8. [DOI: 10.1542/peds.109.2.262] [PMID: ] - DOI - PubMed
Efird 2005 {published data only}
    1. Efird MM, Heerens AT, Gordon PV, Bose CL, Young DA. A randomized-controlled trial of prophylactic hydrocortisone supplementation for the prevention of hypotension in extremely low birth weight infants. Journal of Perinatology 2005;25(2):119-24. [DOI: 10.1038/sj.jp.7211193] [PMID: ] - DOI - PubMed
Ferrara 1990 {published data only}
    1. Ferrara TB, Georgieff MK, Ebert TJ, Fisher JB. Routine use of dexamethasone for the prevention of post-extubation respiratory distress. Journal of Perinatology 1989;9(3):287-90. [PMID: ] - PubMed
Garland 1999 {published data only}
    1. Garland JS, Alex CP, Pauly TH, Whitehead VL, Brand J, Winston JF, et al. A three-day course of dexamethasone therapy to prevent chronic lung disease in ventilated neonates: a randomized trial. Pediatrics 1999;104(1 Pt 1):91-9. [DOI: 10.1542/peds.104.1.91] [PMID: ] - DOI - PubMed
Groneck 1993 {published data only}
    1. Groneck P, Reuss D, Gotze-Speer B, Speer CP. Effects of dexamethasone on chemotactic activity and inflammatory mediators in tracheobronchial aspirates of preterm infants at risk for chronic lung disease. Journal of Pediatrics 1993;122(6):938-44. [DOI: 10.1016/s0022-3476(09)90024-5] [PMID: ] - DOI - PubMed
Halac 1990 {published data only}
    1. Halac E, Halac J, Begue EF, Casanas JM, Indiveri DR, Petit JF, et al. Prenatal and postnatal corticosteroid therapy to prevent neonatal necrotizing enterocolitis: a controlled trial. Journal of Pediatrics 1990;117(1 Pt 1):132-8. [DOI: 10.1016/s0022-3476(05)72461-6] [PMID: ] - DOI - PubMed
Hochwald 2014 {published data only}
    1. Hochwald O, Palegra G, Osiovich H. Adding hydrocortisone as 1st line of inotropic treatment for hypotension in very low birth weight infants. Indian Journal of Pediatrics 2014;81:808-10. [DOI: 10.1007/s12098-013-1151-3 [doi];] [PMID: ] - PubMed
Kopelman 1999 {published data only}
    1. Kopelman AE, Moise AA, Holbert D, Hegemier SE. A single very early dexamethasone dose improves respiratory and cardiovascular adaptation in preterm infants. Journal of Pediatrics 1999;135(3):345-50. [DOI: 10.1016/s0022-3476(99)70132-0] [PMID: ] - DOI - PubMed
Lauterbach 2006 {published data only}
    1. Lauterbach R, Szymura-Oleksiak J, Pawlik D, Warchol J, Lisowska-Miszczyk I, Rytlewski K. Nebulized pentoxifylline for prevention of bronchopulmonary dysplasia in very low birth weight infants: a pilot clinical study. Journal of Maternal-Fetal & Neonatal Medicine 2006;19(7):433-8. [DOI: 10.1080/14767050600736754] [PMID: ] - DOI - PubMed
Lin 1999 {published data only}
    1. Lin YJ, Yeh TF, Hsieh WS, Chi YC, Lin HC, Lin CH. Prevention of chronic lung disease in preterm infants by early postnatal dexamethasone therapy. Pediatric Pulmonology 1999;27(1):21-6. [DOI: 10.1002/(sici)1099-0496(199901)27:1<21::aid-ppul5>3.0.co;2-y] [PMID: ] - DOI - PubMed
Mammel 1983 {published data only}
    1. Mammel MC, Green TP, Johnson TR, Thompson TR. Controlled trial of dexamethasone therapy in infants with bronchopulmonary dysplasia. Lancet 1983;1(8338):1356-8. [DOI: 10.1016/s0140-6736(83)92139-6] [PMID: ] - DOI - PubMed
Marr 2019 {published data only}
    1. Marr BL, Mettelman BB, Bode MM, Gross SJ. Randomized trial of 42-day compared with 9-day courses of dexamethasone for the treatment of evolving bronchopulmonary dysplasia in extremely preterm infants. Journal of Pediatrics 2019;211:20-6.e1. [DOI: 10.1016/j.jpeds.2019.04.047] [PMID: ] - DOI - PubMed
Merz 1999 {published data only}
    1. Merz U, Peschgens T, Kusenbach G, Hörnchen H. Early versus late dexamethasone treatment in preterm infants at risk for chronic lung disease: a randomized pilot study. European Journal of Pediatrics 1999;158(4):318-22. [DOI: 10.1007/s004310051081] [PMID: ] - DOI - PubMed
Mukhopadhyay 1998 {published data only}
    1. Mukhopadhyay K, Kumar P, Narang A. Role of early postnatal dexamethasone in respiratory distress syndrome. Indian Pediatrics 1998;35(2):117-22. [PMID: ] - PubMed
Ng 2006 {published data only}
    1. Ng PC, Lee CH, Bnur FL, Chan IH, Lee AW, Wong E, et al. A double-blind, randomized, controlled study of a "stress dose" of hydrocortisone for rescue treatment of refractory hypotension in preterm infants. Pediatrics 2006;117(2):367-75. [DOI: 10.1542/peds.2005-0869] [PMID: ] - DOI - PubMed
Odd 2004 {published data only}
    1. Odd DE, Armstrong DL, Teele RL, Kuschel CA, Harding JE. A randomized trial of two dexamethasone regimens to reduce side-effects in infants treated for chronic lung disease of prematurity. Journal of Paediatrics and Child Health 2004;40(5-6):282-9. [DOI: 10.1111/j.1440-1754.2004.00364.x] [PMID: ] - DOI - PubMed
Peltoniemi 2005 {published data only}
    1. Peltoniemi O, Kari MA, Heinonen K, Saarela T, Nikolajev K, Andersson S, et al. Pretreatment cortisol values may predict responses to hydrocortisone administration for the prevention of bronchopulmonary dysplasia in high-risk infants. Journal of Pediatrics 2005;146(5):632-7. [DOI: 10.1016/j.jpeds.2004.12.040] [PMID: ] - DOI - PubMed
    1. Peltoniemi OM, Lano A, Puosi R, Yliherva A, Bonsante F, Kari MA, et al, Neonatal Hydrocortisone Working Group. Trial of early neonatal hydrocortisone: two-year follow-up. Neonatology 2009;95(3):240-7. [DOI: 10.1159/000164150] [PMID: ] - DOI - PubMed
Rastogi 1996 {published data only}
    1. Morales P, Rastogi A, Bez ML, Akintorin SM, Pyati S, Andes SM, et al. Effect of dexamethasone therapy on the neonatal ductus arteriosus. Pediatric Cardiology 1998;19(3):225-9. [DOI: 10.1007/s002469900290] [PMID: ] - DOI - PubMed
    1. Rastogi A, Akintorin SM, Bez ML, Morales P, Pildes RS. A controlled trial of dexamethasone to prevent bronchopulmonary dysplasia in surfactant-treated infants. Pediatrics 1996;98(2 Pt 1):204-10. [PMID: ] - PubMed
Romagnoli 1999 {published data only}
    1. Romagnoli C, Zecca E, Luciano R, Torrioli G, Tortorolo G. Controlled trial of early dexamethasone treatment for the prevention of chronic lung disease in preterm infants: a 3-year follow-up. Pediatrics 2002;109(6):e85. [DOI: 10.1542/peds.109.6.e85] [PMID: ] - DOI - PubMed
    1. Romagnoli C, Zecca E, Vento G, De Carolis MP, Papacci P, Tortorolo G. Early postnatal dexamethasone for the prevention of chronic lung disease in high-risk preterm infants. Intensive Care Medicine 1999;25(7):717-21. [DOI: 10.1007/s001340050935] [PMID: ] - DOI - PubMed
    1. Romagnoli C, Zecca E, Vento G, Maggio L, Papacci P, Tortorolo G. Effect on growth of two different dexamethasone courses for preterm infants at risk of chronic lung disease. Pharmacology 1999;59(5):266-74. [DOI: 10.1159/000028329] [PMID: ] - DOI - PubMed
Sanders 1994 {published data only}
    1. Sanders RJ, Cox C, Phelps DL, Sinkin RA. Two doses of early intravenous dexamethasone for the prevention of bronchopulmonary dysplasia in babies with respiratory distress syndrome. Pediatric Research 1994;36(1 Pt 1):122-8. [DOI: 10.1203/00006450-199407001-00022] [PMID: ] - DOI - PubMed
Shinwell 1996 {published data only}
    1. Shinwell ES, Karplus M, Reich D, Weintraub Z, Blazer S, Bader D, et al. Early postnatal dexamethasone treatment and increased incidence of cerebral palsy. Archives of Disease in Childhood. Fetal and Neonatal Edition 2000;83(3):F177-81. [DOI: 10.1136/fn.83.3.f177] [PMID: ] - DOI - PMC - PubMed
    1. Shinwell ES, Karplus M, Zmora E, Reich D, Rothschild A, Blazer S, et al. Failure of early postnatal dexamethasone to prevent chronic lung disease in infants with respiratory distress syndrome. Archives of Disease in Childhood. Fetal and Neonatal Edition 1996;74(1):F33-7. [DOI: 10.1136/fn.74.1.f33] [PMID: ] - DOI - PMC - PubMed
    1. Shinwell ES. Early dexamethasone therapy is associated with increased incidence of cerebral palsy. Hot Topics '99 in Neonatology 1999:240-54.
Sinkin 2000 {published data only}
    1. D'Angio CT, Maniscalco WM, Ryan RM, Avissar NE, Basavegowda K, Sinkin RA. Vascular endothelial growth factor in pulmonary lavage fluid from premature infants: effects of age and postnatal dexamethasone. Biology of the Neonate 1999;76(5):266-73. [DOI: 10.1159/000014168] [PMID: ] - DOI - PubMed
    1. Sinkin RA, Dweck HS, Horgan MJ, Gallaher KJ, Cox C, Maniscalco WM, et al. Early dexamethasone - attempting to prevent chronic lung disease. Pediatrics 2000;105(3 Pt 1):542-8. [DOI: 10.1542/peds.105.3.542] [PMID: ] - DOI - PubMed
Soll 1999 {published data only}
    1. Soll RF, Vermont Oxford Network Steroid Study Group. Early postnatal dexamethasone therapy for the prevention of chronic lung disease. Pediatric Research 1999;45:226A. - PubMed
    1. Vermont Oxford Network Steroid Study Group. Early postnatal dexamethasone therapy for the prevention of chronic lung disease. Pediatrics 2001;108(3):741-8. [DOI: 10.1542/peds.108.3.741] [PMID: ] - DOI - PubMed
Stark 2001 {published data only}
    1. Stark AR, Carlo WA, Tyson JE, Papile LA, Wright LL, Shankaran S, et al, National Institute of Child Health and Human Development Neonatal Research Network. Adverse effects of early dexamethasone in extremely-low-birth-weight infants. New England Journal of Medicine 2001;344(2):95-101. [DOI: 10.1056/NEJM200101113440203] [PMID: ] - DOI - PubMed
    1. Stark AR, Carlo WA, Vohr BR, Papile LA, Saha S, Bauer CR, et al, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Death or neurodevelopmental impairment at 18 to 22 months corrected age in a randomized trial of early dexamethasone to prevent death or chronic lung disease in extremely low birth weight infants. Journal of Pediatrics 2014;164(1):34-39.e2. [DOI: 10.1016/j.jpeds.2013.07.027] [PMID: ] - DOI - PMC - PubMed
Subhedar 1997 {published data only}
    1. Subhedar NV, Bennett AJ, Wardle SP, Shaw NJ. More trials on early treatment with corticosteroids are needed. BMJ (Clinical Research Ed.) 2000;320(7239):941. [PMID: ] - PMC - PubMed
    1. Subhedar NV, Ryan SW, Shaw NJ. Open randomised controlled trial of inhaled nitric oxide and early dexamethasone in high risk preterm infants. Archives of Disease in Childhood. Fetal and Neonatal Edition 1997;77(3):F185-90. [DOI: 10.1136/fn.77.3.f185] [PMID: ] - DOI - PMC - PubMed
Suske 1996 {published data only}
    1. Suske G, Oestreich K, Varnholt V, Lasch P, Kachel W. Influence of early postnatal dexamethasone therapy on ventilator dependency in surfactant-substituted preterm infants. Acta Paediatrica 1996;85(6):713-8. [DOI: 10.1111/j.1651-2227.1996.tb14132.x] [PMID: ] - DOI - PubMed
Tapia 1998 {published data only}
    1. Tapia JL, Ramirez R, Cifuentes J, Fabres J, Hubner ME, Bancalari A, et al. The effect of early dexamethasone administration on bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Journal of Pediatrics 1998;132(1):48-52. [DOI: 10.1016/s0022-3476(98)70483-4] [PMID: ] - DOI - PubMed
Vento 2004a {published data only}
    1. Vento G, Matassa PG, Zecca E, Tortorolo L, Martelli M, De Carolis MP, et al. Effect of dexamethasone on tracheobronchial aspirate fluid cytology and pulmonary mechanics in preterm infants. Pharmacology 2004;71(3):113-9. [DOI: 10.1159/000077444] [PMID: ] - DOI - PubMed
Wang 1996 {published data only}
    1. Wang JY, Yeh TF, Lin YC, Miyamura K, Holmskov U, Reid KB. Measurement of pulmonary status and surfactant protein levels during dexamethasone treatment of neonatal respiratory distress syndrome. Thorax 1996;51(9):907-13. [DOI: 10.1136/thx.51.9.907] [PMID: ] - DOI - PMC - PubMed
    1. Wang JY, Yeh TF, Lin YJ, Chen WY, Lin CH. Early postnatal dexamethasone therapy may lessen lung inflammation in premature infants with respiratory distress syndrome on mechanical ventilation. Pediatrics 1997;23(3):193-7. [DOI: 10.1002/(sici)1099-0496(199703)23:3<193::aid-ppul4>3.0.co;2-p] [PMID: ] - DOI - PubMed
Watterberg 1999 {published data only}
    1. Watterberg KL, Gerdes JS, Gifford KL, Lin HM. Prophylaxis against early adrenal insufficiency to prevent chronic lung disease in premature infants. Pediatrics 1999;104(6):1258-63. [DOI: 10.1542/peds.104.6.1258] [PMID: ] - DOI - PubMed
Watterberg 2004 {published data only}
    1. Watterberg KL, Gerdes JS, Cole CH, Aucott SW, Thilo EH, Mammel MC, et al. Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial. Pediatrics 2004;114(6):1649-57. [DOI: 10.1542/peds.2004-1159] [PMID: ] - DOI - PubMed
    1. Watterberg KL, Shaffer ML, Mishefske MJ, Leach CL, Mammel MC, Couser RJ, et al. Growth and neurodevelopmental outcomes after early low-dose hydrocortisone treatment in extremely low birth weight infants. Pediatrics 2007;120(1):40-8. [DOI: 10.1542/peds.2006-3158] [PMID: ] - DOI - PubMed
Wilson 1988 {published data only}
    1. Wilson DM, Baldwin RB, Ariagno RL. A randomized, placebo-controlled trial of effects of dexamethasone on hypothalamic-pituitary-adrenal axis in preterm infants. Journal of Pediatrics 1988;113(4):764-8. [DOI: 10.1016/s0022-3476(88)80398-6] [PMID: ] - DOI - PubMed
Yeh 1990 {published data only}
    1. Yeh TF, Torre JA, Rastogi A, Anyebuno MA, Pildes RS. Early postnatal dexamethasone therapy in premature infants with severe respiratory distress syndrome: a double-blind, controlled study. Journal of Pediatrics 1990;117(2 Pt 1):273-82. [DOI: 10.1016/s0022-3476(05)80547-5] [PMID: ] - DOI - PubMed
Yeh 1997 {published data only}
    1. Lin YJ, Lin CH, Wu JM, Tsai WH, Yeh TF. The effects of early postnatal dexamethasone therapy on pulmonary outcome in premature infants with respiratory distress syndrome: a two-year follow-up study. Acta Paediatrica 2005;94(3):310-6. [DOI: 10.1111/j.1651-2227.2005.tb03073.x] [PMID: ] - DOI - PubMed
    1. Lin YJ, Yeh TF, Lin HC, Wu JM, Lin CH, Yu CY. Effects of early postnatal dexamethasone therapy on calcium homeostasis and bone growth in preterm infants with respiratory distress syndrome. Acta Paediatrica 1998;87(10):1061-5. [DOI: 10.1080/080352598750031383] [PMID: ] - DOI - PubMed
    1. Peng CT, Lin HC, Lin YJ, Tsai CH, Yeh TF. Early dexamethasone therapy and blood cell count in preterm infants. Pediatrics 1999;104(3 Pt 1):476-81. [DOI: 10.1542/peds.104.3.476] [PMID: ] - DOI - PubMed
    1. Yeh TF, Lin IJ, Hsieh WS, Lin H, Lin C, Chen J, et al. Prevention of chronic lung disease (CLD) in premature RDS infants with early and prolonged dexamethasone (D) therapy - a multicenter double-blind controlled study. Pediatric Research 1994;35(4):262A.
    1. Yeh TF, Lin YJ, Hsieh WS, Lin HC, Lin CH, Chen JY, et al. Early postnatal dexamethasone therapy for the prevention of chronic lung disease in preterm infants with respiratory distress syndrome: a multicenter clinical trial. Pediatrics 1997;100(4):E3. [DOI: 10.1542/peds.100.4.e3] [PMID: ] - DOI - PubMed
Yoder 1991 {published data only}
    1. Yoder MC, Chua R, Tepper R. Effect of dexamethasone on pulmonary inflammation and pulmonary function in ventilator-dependent infants with bronchopulmonary dysplasia. American Review of Respiratory Disease 1991;143(5 Pt 1):1044-8. [DOI: 10.1164/ajrccm/143.5_Pt_1.1044] [PMID: ] - DOI - PubMed

References to ongoing studies

He 2020 {published data only}
    1. He Y, Zhang Y, Gao S, Wang X, He N, Zhang D, et al. Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial. Trials 2020;21(1):762. [DOI: 10.1186/s13063-020-04698-0] [PMID: ] - DOI - PMC - PubMed
NCT01353313 {unpublished data only}
    1. NCT01353313. A randomized controlled trial of the effect of hydrocortisone on survival without bronchopulmonary dysplasia and on neurodevelopmental outcomes at 22 - 26 months of age in intubated infants < 30 weeks' gestation age. clinicaltrials.gov/show/NCT01353313 (first received 20 April 2011).

Additional references

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Arias‐Camison 1999
    1. Arias-Camison JM, Lau J, Cole CH, Frantz ID 3rd. Meta-analysis of dexamethasone therapy started in the first 15 days of life for prevention of chronic lung disease in premature infants. Pediatric Pulmonology 1999;28(3):167-74. [DOI: 10.1002/(sici)1099-0496(199909)28:3<167::aid-ppul2>3.0.co;2-y] [PMID: ] - DOI - PubMed
Bayley 1993
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Bhuta 1998
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References to other published versions of this review

Doyle 2014b
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