Early neonatal dexamethasone treatment for prevention of bronchopulmonary dysplasia. Randomised trial and meta-analysis evaluating the duration of dexamethasone therapy.
The aim of the aborted trial was to determine whether the short early dexamethasone (DX) given after the birth improves the early outcome. We also reviewed the evidence (meta-analysis) to determine whether the duration of early DX treatment influences the early outcome, particularly in terms of bronchopulmonary dysplasia (BPD). The participants of the randomised multicentre, double-blinded placebo-controlled trial had a birth weight 500-999 g, gestation < or = 31.0 weeks, and respiratory failure by the age of 4 h. The infants received either four doses of DX (0.25 mg/kg at 12 h intervals) or placebo. The meta-analysis was performed to determine the beneficial and adverse effects of early short (<96 h duration) versus early prolonged (>96 h) DX treatment. The trial was discontinued after 109 infants had been enrolled. There was a non-significant improvement in the outcome (survival without BPD, severe intracranial haemorrhage or periventricular leukomalacia; RR 1.27; 95% CI 0.87-1.85). The risks for gastrointestinal perforation and hyperglycaemia tended to increase. A total of 15 trials were included in the meta-analysis: 10 involved prolonged (i.e. >96 h; 1594 infants) and five short interventions (1069 infants). Early prolonged DX decreased the RR for BPD to 0.72 (95% CI 0.61-0.87), whereas early short DX course did not significantly decrease the risk (RR 0.82; 95% CI 0.64-1.05). Gastrointestinal haemorrhages and perforations were significantly increased only in the early prolonged DX group.


CONCLUSIONS
The dosage and duration of early corticosteroid given to small premature infants influences the risk of the side-effects and the early outcome.
Anttila
Eija
E
Department of Paediatrics, University of Oulu, 5000, 90014 Oulu, Finland.
Peltoniemi
Outi
O
Haumont
Dominique
D
Herting
Egbert
E
ter Horst
Henk
H
Heinonen
Kirsti
K
Kero
Pentti
P
Nykänen
Päivi
P
Oetomo
Sidarto Bambang
SB
Hallman
Mikko
M
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control*; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D003907:Dexamethasone