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Meta-Analysis
. 2012 Nov 14;11(11):CD001456.
doi: 10.1002/14651858.CD001456.pub2.

Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome

Felicia L Bahadue  1 , Roger Soll
Affiliations
Meta-Analysis

Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome

Felicia L Bahadue et al. Cochrane Database Syst Rev. .

Abstract

Background: Clinical trials have confirmed that surfactant therapy is effective in improving the immediate need for respiratory support and the clinical outcome of premature newborns. Trials have studied a wide variety of surfactant preparations used either to prevent (prophylactic or delivery room administration) or treat (selective or rescue administration) respiratory distress syndrome (RDS). Using either treatment strategy, significant reductions in the incidence of pneumothorax, as well as significant improvement in survival, have been noted. It is unclear whether there are any advantages to treating infants with respiratory insufficiency earlier in the course of RDS.

Objectives: To compare the effects of early versus delayed selective surfactant therapy for newborns intubated for respiratory distress within the first two hours of life. Planned subgroup analyses included separate comparisons for studies utilizing natural surfactant extract and synthetic surfactant.

Search methods: We searched the Oxford Database of Perinatal Trials, MEDLINE (MeSH terms: pulmonary surfactant; text word: early; limits: age, newborn: publication type, clinical trial), PubMed, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. For the updated search in April 2012 we searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2012, Issue 1) and PubMed (January 1997 to April 2012).

Selection criteria: Randomized and quasi-randomized controlled clinical trials comparing early selective surfactant administration (surfactant administration via the endotracheal tube in infants intubated for respiratory distress, not specifically for surfactant dosage) within the first two hours of life versus delayed selective surfactant administration to infants with established RDS were considered for review.

Data collection and analysis: Data regarding clinical outcomes were excerpted from the reports of the clinical trials by the review authors. Subgroup analyses were performed based on type of surfactant preparation, gestational age, and exposure to prenatal steroids. Data analysis was performed in accordance with the standards of the Cochrane Neonatal Review Group.

Main results: Six randomized controlled trials met selection criteria. Two of the trials utilized synthetic surfactant (Exosurf Neonatal) and four utilized animal-derived surfactant preparations.The meta-analyses demonstrate significant reductions in the risk of neonatal mortality (typical risk ratio (RR) 0.84; 95% confidence interval (CI) 0.74 to 0.95; typical risk difference (RD) -0.04; 95% CI -0.06 to -0.01; 6 studies; 3577 infants), chronic lung disease (typical RR 0.69; 95% CI 0.55 to 0.86; typical RD -0.04; 95% CI -0.06 to -0.01; 3 studies; 3041 infants), and chronic lung disease or death at 36 weeks (typical RR 0.83; 95% CI 0.75 to 0.91; typical RD -0.06; 95% CI -0.09 to -0.03; 3 studies; 3050 infants) associated with early treatment of intubated infants with RDS.Intubated infants randomized to early selective surfactant administration also demonstrated a decreased risk of acute lung injury including a decreased risk of pneumothorax (typical RR 0.69; 95% CI 0.59 to 0.82; typical RD -0.05; 95% CI -0.08 to -0.03; 5 studies; 3545 infants), pulmonary interstitial emphysema (typical RR 0.60; 95% CI 0.41 to 0.89; typical RD -0.06; 95% CI -0.10 to -0.02; 3 studies; 780 infants), and overall air leak syndromes (typical RR 0.61; 95% CI 0.48 to 0.78; typical RD -0.18; 95% CI -0.26 to -0.09; 2 studies; 463 infants).A trend toward risk reduction for bronchopulmonary dysplasia (BPD) or death at 28 days was also evident (typical RR 0.94; 95% CI 0.88 to 1.00; typical RD -0.04; 95% CI -0.07 to -0.00; 3 studies; 3039 infants). No differences in other complications of RDS or prematurity were noted.Only two studies reported on infants under 30 weeks' gestation. Decreased risk of neonatal mortality and chronic lung disease or death at 36 weeks' postmenstrual age was noted.

Authors' conclusions: Early selective surfactant administration given to infants with RDS requiring assisted ventilation leads to a decreased risk of acute pulmonary injury (decreased risk of pneumothorax and pulmonary interstitial emphysema) and a decreased risk of neonatal mortality and chronic lung disease compared to delaying treatment of such infants until they develop worsening RDS.

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Conflict of interest statement

Dr. R. Soll has previously acted as a paid consultant and invited speaker for several of the pharmaceutical companies that manufacture surfactant preparations (Abbott Laboratories, Ross Laboratories, Chiesi Pharmaceuticals, Dey Laboratories, Burroughs Wellcome).

Felicia L Bahadue has no conflicts of interest to declare.

Figures

1.1
1.1. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 1 Neonatal mortality.
1.2
1.2. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 2 Mortality at discharge.
1.3
1.3. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 3 Bronchopulmonary dysplasia.
1.4
1.4. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 4 BPD or death at 28 to 30 days.
1.5
1.5. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 5 Chronic lung disease.
1.6
1.6. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 6 CLD or death at 36 weeks' PMA.
1.7
1.7. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 7 Any air leak syndrome.
1.8
1.8. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 8 Pneumothorax.
1.9
1.9. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 9 Pulmonary interstitial emphysema.
1.10
1.10. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 10 Pulmonary hemorrhage.
1.11
1.11. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 11 Patent ductus arteriosus.
1.12
1.12. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 12 Confirmed bacterial sepsis.
1.13
1.13. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 13 Necrotizing enterocolitis.
1.14
1.14. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 14 Intraventricular hemorrhage (any).
1.15
1.15. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 15 Intraventricular hemorrhage (severe).
1.16
1.16. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 16 Periventricular leukomalacia.
1.17
1.17. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 17 Retinopathy of prematurity (any).
1.18
1.18. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 18 Retinopathy of prematurity stage 3 or greater.
1.19
1.19. Analysis
Comparison 1 Early versus delayed selective surfactant treatment, Outcome 19 Long‐term follow‐up.
2.1
2.1. Analysis
Comparison 2 Early versus delayed selective surfactant treatment in infants less than 30 weeks' gestation, Outcome 1 Neonatal mortality.
2.2
2.2. Analysis
Comparison 2 Early versus delayed selective surfactant treatment in infants less than 30 weeks' gestation, Outcome 2 Mortality at discharge.
2.3
2.3. Analysis
Comparison 2 Early versus delayed selective surfactant treatment in infants less than 30 weeks' gestation, Outcome 3 Chronic lung disease.
2.4
2.4. Analysis
Comparison 2 Early versus delayed selective surfactant treatment in infants less than 30 weeks' gestation, Outcome 4 CLD or death at 36 weeks' PMA.
3.1
3.1. Analysis
Comparison 3 Early versus delayed selective surfactant treatment by steroid exposure, Outcome 1 Neonatal mortality.
3.2
3.2. Analysis
Comparison 3 Early versus delayed selective surfactant treatment by steroid exposure, Outcome 2 Mortality at discharge.
3.3
3.3. Analysis
Comparison 3 Early versus delayed selective surfactant treatment by steroid exposure, Outcome 3 Bronchopulmonary dysplasia.
3.4
3.4. Analysis
Comparison 3 Early versus delayed selective surfactant treatment by steroid exposure, Outcome 4 BPD or death at 28 to 30 days.
3.5
3.5. Analysis
Comparison 3 Early versus delayed selective surfactant treatment by steroid exposure, Outcome 5 Chronic lung disease.
3.6
3.6. Analysis
Comparison 3 Early versus delayed selective surfactant treatment by steroid exposure, Outcome 6 CLD or death at 36 weeks' PMA.
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Update of

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