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Meta-Analysis
. 2010 Jan 20;2010(1):CD000164.
doi: 10.1002/14651858.CD000164.pub2.

Phenobarbital prior to preterm birth for preventing neonatal periventricular haemorrhage

Caroline A Crowther  1 , Danielle D Crosby, David J Henderson-Smart
Affiliations
Meta-Analysis

Phenobarbital prior to preterm birth for preventing neonatal periventricular haemorrhage

Caroline A Crowther et al. Cochrane Database Syst Rev. .

Abstract

Background: Preterm infants are at risk of periventricular haemorrhage. Phenobarbital might prevent ischaemic injury or reduce fluctuations in blood pressure and blood flow in the brain.

Objectives: To assess the benefits and harms of giving phenobarbital to women at risk of imminent very preterm birth with the primary aim of preventing periventricular haemorrhage in the infant.

Search strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2008).

Selection criteria: Randomised trials with reported data that compared neonatal and maternal outcomes following prenatal exposure to phenobarbital, with outcomes in controls with or without placebo.

Data collection and analysis: We independently assessed trial eligibility and quality and extracted data. We included eligible trials in the initial analysis and prespecified sensitivity analyses to evaluate the effect of trial quality.

Main results: Nine trials (1752 women) were included. Analyses of all included trials showed a significant reduction in the rates of all grades of periventricular haemorrhage (PVH) (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.50 to 0.83; nine trials; 1591 women) and severe grades PVH (3 and 4) (RR 0.41, 95% CI 0.20 to 0.85; eight trials; 1527 women) in infants whose mothers had been given prenatal phenobarbital. These results were influenced by trials of poor quality which contributed excessive weight in the analysis due to their higher rates of severe PVH. When only the two higher quality trials were included, these beneficial effects disappeared for all grades of PVH (RR 0.90, 95% CI 0.75 to 1.08; two trials; 945 women), and severe grades of PVH (RR 1.05, 95% CI 0.60 to 1.83; two trials; 945 women).No difference was found in the incidence of neurodevelopmental abnormalities at paediatric follow up at 18 to 24 months or seven years of age between children born to mothers given prenatal phenobarbital and children not so exposed. Maternal sedation was more likely in women receiving phenobarbital (RR 2.06, 95% CI 1.79 to 2.37; one trial; 576 women).

Authors' conclusions: The evidence in this review does not support the use of prophylactic maternal phenobarbital administration to prevent periventricular haemorrhage in preterm infants or to protect them from neurological disability in childhood. Phenobarbital administration may lead to maternal sedation. If any future trials are carried out, they should measure neurodevelopmental status at follow up.

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Conflict of interest statement

None known.

Figures

1
1
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
1.1
1.1. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 1 All periventricular haemorrhage (PVH).
1.2
1.2. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 2 Severe (grades 3 and 4) PVH.
1.3
1.3. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 3 Perinatal mortality.
1.4
1.4. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 4 Infant death prior to discharge or severe PVH.
1.5
1.5. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 5 Early infant death or any PVH.
1.6
1.6. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 6 Early infant death or severe PVH.
1.7
1.7. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 7 Low Apgar score at 5 minutes.
1.8
1.8. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 8 Use of mechanical ventilation.
1.9
1.9. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 9 Respiratory distress syndrome.
1.10
1.10. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 10 Pulmonary air leak.
1.11
1.11. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 11 Patent ductus arteriosus.
1.12
1.12. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 12 Cerebral palsy at 18‐36 months follow up.
1.13
1.13. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 13 Cerebral palsy at 7 year follow up.
1.14
1.14. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 14 Other neuromotor impairment at 36 month follow up.
1.15
1.15. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 15 Developmental delay at 18‐22 months follow up.
1.16
1.16. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 16 Visual impairment at 18‐36 months follow up.
1.17
1.17. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 17 Hearing impairment at 18‐36 months follow up.
1.18
1.18. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 18 Bayley Mental Developmental Index at 18‐24 months.
1.19
1.19. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 19 Bayley Psychomotor Developmental Index at 18‐24 months.
1.20
1.20. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 20 Wechsler Intelligence Scale for Children at 7 year follow up.
1.21
1.21. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 21 Wide Range Achievement Test at 7 year follow up.
1.22
1.22. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 22 Achenbach Teacher's Report Form at 7 year follow up.
1.23
1.23. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 23 Child Behavioral Check List total at 7 year follow up.
1.24
1.24. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 24 Height (cm) at 18‐24 months follow up (mean, standard deviation).
1.25
1.25. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 25 Height < 5th centile at 18‐24 month follow up.
1.26
1.26. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 26 Weight (kg) at 18‐24 month follow up (mean, standard deviation).
1.27
1.27. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 27 Weight < 5th centile at 18‐24 month follow up.
1.28
1.28. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 28 Head circumference (cm) at childhood follow up (mean, standard deviation).
1.29
1.29. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 29 Head circumference < 5th centile at childhood follow up.
1.30
1.30. Analysis
Comparison 1 Phenobarbital versus control ‐ all studies, Outcome 30 Maternal sedation.
2.1
2.1. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 1 All periventricular haemorrhage (PVH).
2.2
2.2. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 2 Severe (grades 3 and 4) PVH.
2.3
2.3. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 3 Perinatal mortality.
2.4
2.4. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 4 Infant death prior to discharge or severe PVH.
2.5
2.5. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 5 Early infant death or any PVH.
2.6
2.6. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 6 Early infant death or severe PVH.
2.7
2.7. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 7 Low Apgar score at 5 minutes.
2.8
2.8. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 8 Use of mechanical ventilation.
2.9
2.9. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 9 Respiratory distress syndrome.
2.10
2.10. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 10 Pulmonary air leak.
2.11
2.11. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 11 Patent ductus arteriosus.
2.12
2.12. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 12 Cerebral palsy at 18‐36 months follow up.
2.13
2.13. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 13 Cerebral palsy at 7 year follow up.
2.14
2.14. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 14 Other neuromotor impairment at 36 month follow up.
2.15
2.15. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 15 Visual impairment at 18‐36 months follow up.
2.16
2.16. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 16 Hearing impairment at 18‐36 months follow up.
2.17
2.17. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 17 Bayley Mental Developmental Index at 18‐24 months.
2.18
2.18. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 18 Bayley Psychomotor Developmental Index at 18‐24 months.
2.19
2.19. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 19 Wechsler Intelligence Scale for Children at 7 year follow up.
2.20
2.20. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 20 Wide Range Achievement Test at 7 year follow up.
2.21
2.21. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 21 Achenbach Teacher's Report Form at 7 year follow up.
2.22
2.22. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 22 Child Behavioral Check List total at 7 year follow up.
2.23
2.23. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 23 Height (cm) at childhood follow up.
2.24
2.24. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 24 Height < 5th centile at childhood follow up.
2.25
2.25. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 25 Weight (kg) at childhood follow up.
2.26
2.26. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 26 Weight < 5th centile at childhood follow up.
2.27
2.27. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 27 Head circumference (cm) at childhood follow up.
2.28
2.28. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 28 Head circumference < 5th centile at childhood follow up.
2.29
2.29. Analysis
Comparison 2 Phenobarbital versus control ‐ excluding trial with non‐concealment at randomisation (C quality), Outcome 29 Maternal sedation.
3.1
3.1. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 1 All periventricular haemorrhage (PVH).
3.2
3.2. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 2 Severe (grades 3 and 4) PVH.
3.3
3.3. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 3 Perinatal mortality.
3.4
3.4. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 4 Early infant death or any PVH.
3.5
3.5. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 5 Low Apgar score at 5 minutes.
3.6
3.6. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 6 Use of mechanical ventilation.
3.7
3.7. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 7 Pulmonary air leak.
3.8
3.8. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 8 Patent ductus arteriosus.
3.9
3.9. Analysis
Comparison 3 Phenobarbital versus control ‐ high‐quality trials only (A for allocation concealment and < 20% exclusions), Outcome 9 Maternal sedation.
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Update of

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References to other published versions of this review

Crowther 1995
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