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. 2021 Oct 21;10(10):CD001146.
doi: 10.1002/14651858.CD001146.pub6.

Early (< 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

Early (< 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants

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

Abstract

Background: Bronchopulmonary dysplasia (BPD) remains a major problem for infants born extremely preterm. Persistent inflammation in the lungs is important in its pathogenesis. Systemic corticosteroids have been used to prevent or treat BPD because of their potent anti-inflammatory effects.

Objectives: To examine the relative benefits and adverse effects of systemic postnatal corticosteroids commenced within the first six days after birth for preterm infants at risk of developing BPD.

Search methods: We ran an updated search of the following databases on 25 September 2020: 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 cluster randomised trials, cross-over trials, or quasi-RCTs.

Selection criteria: For this review, we selected RCTs examining systemic (intravenous or oral) postnatal corticosteroid treatment started within the first six days after birth (early) in high-risk preterm infants. We included studies that evaluated the use of dexamethasone, as well as studies that assessed hydrocortisone, even when the latter was used primarily for management of hypotension, rather than for treatment of lung problems. 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, mortality or BPD, failure to extubate, complications during the primary hospitalisation, and long-term health and neurodevelopmental outcomes. 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 the major outcomes considered, except for BPD at 36 weeks for all studies combined, which was downgraded one level to moderate because of evidence of publication bias. We included 32 RCTs (4395 infants). The overall risk of bias of included studies was low; all were RCTs, and most trials used rigorous methods. Early systemic corticosteroids overall have little or no effect on mortality to the latest reported age (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.85 to 1.06; 31 studies, 4373 infants; high-certainty evidence), but hydrocortisone alone reduces mortality (RR 0.80, 95% CI 0.65 to 0.99; 11 studies, 1433 infants; high-certainty evidence). Early systemic corticosteroids overall probably reduce BPD at 36 weeks' postmenstrual age (PMA) (RR 0.80, 95% CI 0.73 to 0.88; 26 studies, 4167 infants; moderate-certainty evidence), as does dexamethasone (RR 0.72, 95% CI 0.63 to 0.82; 17 studies, 2791 infants; high-certainty evidence), but hydrocortisone has little to no effect (RR 0.92, 95% CI 0.81 to 1.06; 9 studies, 1376 infants; high-certainty evidence). Early systemic corticosteroids overall reduce the combined outcome of mortality or BPD at 36 weeks' PMA (RR 0.89, 95% CI 0.84 to 0.94; 26 studies, 4167 infants; high-certainty evidence), as do both dexamethasone (RR 0.88, 95% CI 0.81 to 0.95; 17 studies, 2791 infants; high-certainty evidence) and hydrocortisone (RR 0.90, 95% CI 0.82 to 0.99; 9 studies, 1376 infants; high-certainty evidence). Early systemic corticosteroids overall increase gastrointestinal perforation (RR 1.84, 95% CI 1.36 to 2.49; 16 studies, 3040 infants; high-certainty evidence), as do both dexamethasone (RR 1.73, 95% CI 1.20 to 2.51; 9 studies, 1936 infants; high-certainty evidence) and hydrocortisone (RR 2.05, 95% CI 1.21 to 3.47; 7 studies, 1104 infants; high-certainty evidence). Early systemic corticosteroids overall increase cerebral palsy (RR 1.43, 95% CI 1.07 to 1.92; 13 studies, 1973 infants; high-certainty evidence), as does dexamethasone (RR 1.77, 95% CI 1.21 to 2.58; 7 studies, 921 infants; high-certainty evidence) but not hydrocortisone (RR 1.05, 95% CI 0.66 to 1.66; 6 studies, 1052 infants; high-certainty evidence). Early systemic corticosteroids overall have little to no effect on the combined outcome of mortality or cerebral palsy (RR 1.03, 95% CI 0.91 to 1.16; 13 studies, 1973 infants; high-certainty evidence), nor does hydrocortisone (RR 0.86, 95% CI 0.71 to 1.05; 6 studies, 1052 infants; high-certainty evidence). However, early dexamethasone probably increases the combined outcome of mortality or cerebral palsy (RR 1.18, 95% CI 1.01 to 1.37; 7 studies, 921 infants; high-certainty evidence), In sensitivity analyses by primary intention for treatment with hydrocortisone (lung problems versus hypotension), there was little evidence of differences in effects on major outcomes of mortality, BPD, or combined mortality or BPD, by indication for the drug.

Authors' conclusions: Early systemic postnatal corticosteroid treatment (started during the first six days after birth) prevents BPD and the combined outcome of mortality or BPD. However, it increases risks of gastrointestinal perforation, cerebral palsy, and the combined outcome of mortality or cerebral palsy. Most beneficial and harmful effects are related to early treatment with dexamethasone, rather than to early treatment with hydrocortisone, but early hydrocortisone may prevent mortality, whereas early dexamethasone does not. 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 early 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 early corticosteroids, particularly of hydrocortisone, should include longer-term survival free of neurodevelopmental disability as the primary outcome.

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Conflict of interest statement

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

Lex Doyle's institution received grant funding from the National Health and Medical Research Council (NHMRC) of Australia.

Henry Halliday declared no conflicts of interest.

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, Parkville, Victoria, Australia.

Figures

1
1
Study flow diagram: review update.
2
2
Risk of bias table.
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 (36 weeks' postmenstrual age).
6
6
Funnel plot of comparison: 3 Death or bronchopulmonary dysplasia (BPD), outcome: 3.2 Death or BPD at 36 weeks' postmenstrual age.
7
7
Funnel plot of comparison: 5 Complications during primary hospitalisation, outcome: 5.15 Gastrointestinal perforation.
8
8
Funnel plot of comparison: 6 Long‐term follow‐up, outcome: 6.11 Cerebral palsy.
9
9
Funnel plot of comparison: 6 Long‐term follow‐up, outcome: 6.13 Death or cerebral palsy.
1.1
1.1. Analysis
Comparison 1: Mortality at different ages, Outcome 1: Neonatal mortality (up to 28 days)
1.2
1.2. Analysis
Comparison 1: Mortality at different ages, Outcome 2: Mortality at 36 weeks
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) at different ages, Outcome 1: BPD (28 days of life)
2.2
2.2. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD) at different ages, Outcome 2: BPD (36 weeks' postmenstrual age)
2.3
2.3. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD) at different ages, Outcome 3: BPD at 36 weeks' postmenstrual age in survivors to 36 weeks
2.4
2.4. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD) at different ages, Outcome 4: Late rescue with corticosteroids
2.5
2.5. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD) at different ages, Outcome 5: Survivors who had late rescue with corticosteroids
2.6
2.6. Analysis
Comparison 2: Bronchopulmonary dysplasia (BPD) at different ages, Outcome 6: Survivors discharged home on oxygen
3.1
3.1. Analysis
Comparison 3: Mortality or bronchopulmonary dysplasia (BPD) at different ages, Outcome 1: Death or BPD at 28 days of life
3.2
3.2. Analysis
Comparison 3: Mortality or bronchopulmonary dysplasia (BPD) at different ages, Outcome 2: Death or BPD at 36 weeks' postmenstrual age
4.1
4.1. Analysis
Comparison 4: Failure to extubate at different ages, Outcome 1: Failure to extubate by third day
4.2
4.2. Analysis
Comparison 4: Failure to extubate at different ages, Outcome 2: Failure to extubate by seventh day
4.3
4.3. Analysis
Comparison 4: Failure to extubate at different ages, Outcome 3: Failure to extubate by 14th day
4.4
4.4. Analysis
Comparison 4: Failure to extubate at different ages, Outcome 4: Failure to extubate by 28th day
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: Hypertension
5.4
5.4. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 4: Hypertrophic cardiomyopathy
5.5
5.5. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 5: Growth failure
5.6
5.6. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 6: Pulmonary air leak
5.7
5.7. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 7: Patent ductus arteriosus (PDA)
5.8
5.8. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 8: Severe IVH
5.9
5.9. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 9: Severe intraventricular haemorrhage (IVH) in infants examined
5.10
5.10. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 10: Periventricular leukomalacia (PVL)
5.11
5.11. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 11: PVL in infants with cranial ultrasound scans
5.12
5.12. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 12: PVL in survivors seen at follow‐up
5.13
5.13. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 13: Necrotising enterocolitis (NEC)
5.14
5.14. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 14: Gastrointestinal bleeding
5.15
5.15. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 15: Gastrointestinal perforation
5.16
5.16. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 16: Pulmonary haemorrhage
5.17
5.17. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 17: Any retinopathy of prematurity (ROP)
5.18
5.18. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 18: Severe ROP
5.19
5.19. Analysis
Comparison 5: Complications during primary hospitalisation, Outcome 19: Severe ROP in survivors
6.1
6.1. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 1: Bayley Mental Developmental Index (MDI) < ‐2 SD
6.2
6.2. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 2: Bayley MDI < ‐2 SD in tested survivors
6.3
6.3. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 3: Bayley Psychomotor Developmental Index (PDI) < ‐2 SD
6.4
6.4. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 4: Bayley PDI < ‐2 SD in tested survivors
6.5
6.5. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 5: Developmental delay (other criteria)
6.6
6.6. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 6: Developmental delay (other criteria) in tested survivors
6.7
6.7. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 7: Blindness
6.8
6.8. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 8: Blindness in survivors assessed
6.9
6.9. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 9: Deafness
6.10
6.10. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 10: Deafness in survivors assessed
6.11
6.11. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 11: Cerebral palsy
6.12
6.12. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 12: Death before follow‐up in trials assessing cerebral palsy
6.13
6.13. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 13: Death or cerebral palsy
6.14
6.14. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 14: Cerebral palsy in survivors assessed
6.15
6.15. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 15: Major neurosensory disability (variable criteria ‐ see individual studies)
6.16
6.16. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 16: Death before follow‐up in trials assessing major neurosensory disability (variable criteria)
6.17
6.17. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 17: Death or major neurosensory disability (variable criteria)
6.18
6.18. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 18: Major neurosensory disability in survivors examined (variable criteria)
6.19
6.19. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 19: Abnormal neurological exam (variable criteria ‐ see individual studies)
6.20
6.20. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 20: Death before follow‐up in trials assessing abnormal neurological exam (variable criteria)
6.21
6.21. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 21: Death or abnormal neurological exam (variable criteria)
6.22
6.22. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 22: Abnormal neurological exam in tested survivors (variable criteria)
6.23
6.23. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 23: Intellectual impairment (IQ < 70)
6.24
6.24. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 24: Intellectual impairment (IQ < 70) in survivors assessed
6.25
6.25. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 25: "Major neurosensory impairment" ‐ blindness or deafness
6.26
6.26. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 26: "Major neurosensory impairment" ‐ blindness or deafness ‐ in survivors assessed
6.27
6.27. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 27: Behaviour abnormalities
6.28
6.28. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 28: Behaviour abnormalities in 3‐year‐old survivors assessed
6.29
6.29. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 29: Abnormal EEG
6.30
6.30. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 30: Abnormal EEG in tested survivors
6.31
6.31. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 31: Re‐hospitalisation in infancy
6.32
6.32. Analysis
Comparison 6: Long‐term follow‐up into later childhood, Outcome 32: Re‐hospitalisation in infancy in survivors
7.1
7.1. Analysis
Comparison 7: Sensitivity analyses by indication for hydrocortisone, Outcome 1: Mortality to latest age
7.2
7.2. Analysis
Comparison 7: Sensitivity analyses by indication for hydrocortisone, Outcome 2: Bronchopulmonary dysplasia at 36 weeks
7.3
7.3. Analysis
Comparison 7: Sensitivity analyses by indication for hydrocortisone, Outcome 3: Mortality or bronchopulmonary dysplasia at 36 weeks
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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 L, 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):34-9 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 2000;320(7239):941. [PMID: 10742018 ] - 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
    1. Subhedar NV.Personal communication. email 2002.
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 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
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. Pediatric Pulmonology 1997;23(3):193-7. [DOI: 10.1002/(sici)1099-0496(199703)23:3<193::aid-ppul4>3.0.co;2-p] [PMID: ] - 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
    1. Watterberg KL.Personal communication. email 2002.
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
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 I, Shieh W, Lin H, Chen J, Kao S.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: ] - PubMed

References to studies excluded from this review

Ariagno 1987 {unpublished data only}
    1. Ariagno RL, Sweeney TE, Baldwin RB, Inguillo D, Martin D.Controlled trial of dexamethasone in preterm infants at risk for bronchopulmonary dysplasia: lung function, clinical course and outcome at three years (as supplied 2000). Data on file.
    1. Ariagno RL, Sweeney TJ, Baldwin RB, Inguillo D, Martin D.Dexamethasone effects on lung function and risks in 3 week old ventilatory dependent preterm infants. American Reviews of Respiratory Disease 1987;135:A125.
Avery 1985 {published data only}
    1. Avery GB, Fletcher AB, Kaplan M, Brudno DS.Controlled trial of dexamethasone in respirator-dependent infants with bronchopulmonary dysplasia. Pediatrics 1985;75(1):106-11. [PMID: ] - PubMed
Bouchier 1997 {published data only}
    1. Bourchier D, Weston PJ.Randomised trial of dopamine compared with hydrocortisone for the treatment of hypotensive very low birthweight infants. Archives of Disease in Childhood. Fetal and Neonatal Edition 1997;76(3):F174-8. [DOI: 10.1136/fn.76.3.f174] [PMID: ] - DOI - PMC - PubMed
Brozanski 1995 {published data only}
    1. Brozanski BS, Jones JG, Gilmour CH, Balsan MJ, Vazquez RL, Israel BA, et al.Effect of pulse dexamethasone therapy on the incidence and severity of chronic lung disease in the very low birth weight infant. Journal of Pediatrics 1995;126(5 Pt 1):769-76. [DOI: 10.1016/s0022-3476(95)70410-8] [PMID: ] - DOI - PubMed
    1. Gilmour CH, Sentipal-Walerius JM, Jones JG, Doyle JM, Brozanski BS, Balsan MJ, et al.Pulse dexamethasone does not impair growth and body composition of very low birth weight infants. Journal of the American College of Nutrition 1995;14(5):455-62. [DOI: 10.1080/07315724.1995.10718536] [PMID: ] - DOI - PubMed
    1. Hofkosh D, Brozanski BS, Edwards DE, Williams LA, Jones JG, Cheng KP.One year outcome of infants treated with pulse dexamethasone for prevention of BPD. Pediatric Research 1995;37(4):259A.
CDTG 1991 {published data only}
    1. Collaborative Dexamethasone Trial Group.Dexamethasone therapy in neonatal chronic lung disease: an international placebo-controlled trial. Pediatrics 1991;88(3):421-7. [PMID: ] - PubMed
    1. Jones R, Wincott E, Elbourne D, Grant A.Controlled trial of dexamethasone in neonatal chronic lung disease: a 3-year follow-up. Pediatrics 1995;96(5 Pt 1):897-906. [PMID: ] - PubMed
    1. Jones RA, Collaborative Dexamethasone Trial Follow-up Group.Randomized, controlled trial of dexamethasone in neonatal chronic lung disease: 13- to 17-year follow-up study: I. Neurologic, psychological, and educational outcomes. Pediatrics 1995;116(2):370-8. [DOI: 10.1542/peds.2004-1818] [PMID: ] - DOI - PubMed
    1. Jones RA, Collaborative Dexamethasone Trial Follow-up Group.Randomized, controlled trial of dexamethasone in neonatal chronic lung disease: 13- to 17-year follow-up study: II. Respiratory status, growth, and blood pressure. Pediatrics 2005;116(2):379-84. [DOI: 10.1542/peds.2004-1819] [PMID: ] - DOI - PubMed
Cummings 1989 {published data only}
    1. Cummings JJ, D'Eugenio DB, Gross SJ.A controlled trial of dexamethasone in preterm infants at high risk for bronchopulmonary dysplasia. New England Journal of Medicine 1989;320(23):1505-10. [DOI: 10.1056/NEJM198906083202301] [PMID: ] - DOI - PubMed
    1. Cummings JJ.Personal communication. email 2002.
    1. Gross SJ, Anbar RD, Mettelman BB.Follow-up at 15 years of preterm infants from a controlled trial of moderately early dexamethasone for the prevention of chronic lung disease. Pediatrics 2005;115(3):681-7. [DOI: 10.1542/peds.2004-0956] [PMID: ] - DOI - PubMed
Dobryansky 2012 {published data only}
    1. Dobryansky D, Borysiuk O, Salabay Z, Dubrovna Y.Clinical effectiveness of early administration of caffeine and low-dose hydrocortisone to preterm newborns with a high risk of BPD development. Archives of Disease in Childhood 2012;97:A119. [DOI: 10.1136/archdischild-2012-302724.0405] - DOI
Doyle 2006 {published data only}
    1. Doyle LW, Davis PG, Morley CJ, McPhee A, Carlin JB, DART Study Investigators.Outcome at 2 years of age of infants from the DART study: a multicenter, international, randomized, controlled trial of low-dose dexamethasone. Pediatrics 2007;119(4):716-21. [DOI: 10.1542/peds.2006-2806] [PMID: 17403842 ] - DOI - PubMed
    1. Doyle LW, Davis PG, Morley CJ, McPhee A, Carlin JB.Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trial. Pediatrics 2006;117(1):75-83. [DOI: 10.1542/peds.2004-2843] [PMID: ] - DOI - PubMed
Durand 1995 {published data only}
    1. Durand M, Sardesai S, McEvoy C.Effects of early dexamethasone therapy on pulmonary mechanics and chronic lung disease in very low birth weight infants: a randomized, controlled trial. Pediatrics 1995;95(4):584-90. [PMID: ] - PubMed
Gaissmaier 1999 {published data only}
    1. Gaissmaier RE, Pohlandt F.Single-dose dexamethasone treatment of hypotension in preterm infants. Journal of Pediatrics 1999;134(6):701-5. [DOI: 10.1016/s0022-3476(99)70284-2] [PMID: ] - DOI - PubMed
Gross 2005 {published data only}
    1. Gross SJ, Anbar RD, Mettelman BB.Follow-up at 15 years of preterm infants from a controlled trial of moderately early dexamethasone for the prevention of chronic lung disease. Pediatrics 2005;115(3):681-7. [10.1542/peds.2004-0956] [PMID: ] - PubMed
Harkavy 1989 {published data only}
    1. Harkavy KL, Scanlon JW, Chowdhry PK, Grylack LJ.Dexamethasone therapy for chronic lung disease in ventilator- and oxygen-dependent infants: a controlled trial. Journal of Pediatrics 1989;115(6):979-83. [DOI: 10.1016/s0022-3476(89)80754-1] [PMID: ] - DOI - PubMed
Kari 1993 {published data only}
    1. Kari MA, Heinonen K, Ikonen RS, Koivisto M, Raivio KO.Dexamethasone treatment in preterm infants at risk for bronchopulmonary dysplasia. Archives of Disease in Childhood 1993;68(5 Spec No):566-9. [DOI: 10.1136/adc.68.5_spec_no.566] [PMID: ] - DOI - PMC - PubMed
    1. Kari MA, Raivio KO, Venge P, Hallman M.Dexamethasone treatment of infants at risk for chronic lung disease: surfactant components and inflammatory parameters in airway specimens. Pediatric Research 1994;36(3):387-93. [DOI: 10.1203/00006450-199409000-00020] [PMID: ] - DOI - PubMed
    1. Mieskonen S, Eronen M, Malmberg LP, Turpeinen M, Kari MA, Hallman M.Controlled trial of dexamethasone in neonatal chronic lung disease: an 8-year follow-up of cardiopulmonary function and growth. Acta Paediatrica 2003;92(8):896-904. [PMID: ] - PubMed
Kazzi 1990 {published data only}
    1. Kazzi NJ, Brans YW, Poland RL.Dexamethasone effects on the hospital course of infants with bronchopulmonary dysplasia who are dependent on artificial ventilation. Pediatrics 1990;86(5):722-7. [PMID: ] - PubMed
Kothadia 1999 {published data only}
    1. Bensky AS, Kothadia JM, Covitz W.Cardiac effects of dexamethasone in very low birth weight infants. Pediatrics 1996;97(6 Pt 1):818-21. [PMID: ] - PubMed
    1. Goldstein DJ, Waldrep EL, VanPelt JC, O'Shea TM.Developmental outcome at 5 years following dexamethasone use for very low birth weight infants. Pediatric Research 2000;47(4):310A.
    1. Kothadia JM, O'Shea TM, Roberts D, Auringer ST, Weaver RG 3rd, Dillard RG.Randomized placebo-controlled trial of a 42-day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants. Pediatrics 1999;104(1 Pt 1):22-7 Erratum in: Pediatrics 2004;114(6):1746. [DOI: 10.1542/peds.104.1.22] [PMID: ] - DOI - PubMed
    1. Nixon PA, Washburn LK, Schechter MS, O'Shea TM.Follow-up study of a randomized controlled trial of postnatal dexamethasone therapy in very low birth weight infants: effects on pulmonary outcomes at age 8 to 11 years. Journal of Pediatrics 2007;150(4):345-50. [DOI: 10.1016/j.jpeds.2006.12.013] [PMID: ] - DOI - PMC - PubMed
    1. O'Shea TM, Goldstein DJ, Jackson BG, Kothadia JM, Dillard RG.Randomized trial of a 42-day tapering course of dexamethasone in very low birth weight infants: neurological, medical and functional outcome at 5 years of age. Pediatric Research 2000;47(4):319A. [DOI: 10.1016/j.jpeds.2019.04.047] [PMID: 31349916] - DOI - PubMed
Kovacs 1998 {published data only}
    1. Kovacs L, Davis GM, Faucher D, Papageorgiou A.Efficacy of sequential early systemic and inhaled corticosteroid therapy in the prevention of chronic lung disease of prematurity. Acta Paediatrica 1998;87(7):792-8. [DOI: 10.1080/080352598750013905] [PMID: ] - DOI - PubMed
Noble‐Jamieson 1989 {published data only}
    1. Noble-Jamieson CM, Regev R, Silverman M.Dexamethasone in neonatal chronic lung disease: pulmonary effects and intracranial complications. European Journal of Pediatrics 1989;148(4):365-7. [DOI: 10.1007/BF00444135] [PMID: ] - DOI - PubMed
Ohlsson 1992 {published data only}
    1. Ohlsson A, Calvert SA, Hosking M, Shennan AT.Randomized controlled trial of dexamethasone treatment in very-low-birth-weight infants with ventilator-dependent chronic lung disease. Acta Paediatrica 1992;81(10):751-6. [DOI: 10.1111/j.1651-2227.1992.tb12096.x] [PMID: ] - PubMed
Onland 2019 {published data only}
    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;321:354-63. [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 very 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
Romagnoli 1997 {published data only}
    1. Romagnoli C, Vento G, Zecca E, Tortorolo G, Papacci P, De Carolis M, 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.
    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. A randomized trial. Pharmacology 1999;59(5):266-74. [DOI: 10.1159/000028329] [PMID: ] - DOI - PubMed
Salas 2014 {published data only}
    1. Salas G, Travaglianti M, Leone A, Couceiro C, Rodríguez S, Fariña D.Hydrocortisone for the treatment of refractory hypotension:a randomised controlled trial [Hidrocortisona para el tratamiento de hipotensión refractaria: ensayo clínico controlado y aleatorizado]. Anales de Pediatria 2014;80(6):387-93. [DOI: 10.1016/j.anpedi.2013.08.004] [PMID: ] - DOI - 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
Smolkin 2014 {published data only}
    1. Smolkin T, Ulanovsky I, Jubran H, Blazer S, Makhoul IR.Experience with oral betamethasone in extremely low birthweight infants with bronchopulmonary dysplasia. Archives of Disease in Childhood. Fetal and Neonatal Edition 2014;99(6):F517-8. [DOI: 10.1136/archdischild-2014-306619] [PMID: ] - DOI - PubMed
Tsukahara 1999 {published data only}
    1. Tsukahara H, Watanabe Y, Yasutomi M, Kobata R, Tamura S, Kimura K, et al.Early (4-7 days of age) dexamethasone therapy for prevention of chronic lung disease in preterm infants. Biology of the Neonate 1999;76(5):283-90. [DOI: 10.1159/000014170] [PMID: ] - DOI - PubMed
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.
Walther 2003 {published data only}
    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
Yaseen 1999 {published data only}
    1. Yaseen H, Okash I, Hanif M, al-Umran K, al-Faraidy A.Early dexamethasone treatment in preterm infants treated with surfactant: a double blind controlled trial. Journal of Tropical Pediatrics 1999;45(5):304-6. [DOI: 10.1093/tropej/45.5.304] [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. Efficacy and Mechanism Evaluation 2019;6:8. [DOI: 10.3310/eme06080] [PMID: ] - DOI - PubMed

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