Thirty VLBW infants requiring assisted mechanical ventilation (either intermittent mandatory ventilation or continuous positive airway pressure)were entered in a double blind randomized controlled trial to try to ameliorate the severity of bronchopulmonary dysplasia (Vincer et al: Acta Pæd Scand 1987;76:894). They received either early prophylactic indomethacin (0.2 mg/kg) or an equal volume of saline placebo at 12, 24 and 36 hours after birth. As a safety measure, these infants were evaluated in the Perinatal Follow-Up Program of Nova Scotia at 2 years corrected gestational age. 5/12 in the indomethacin group and 1/12 in the placebo group developed CP (p=0.15, Fisher's Exact). One infant in the placebo group, who developed CP, probably received indomethacin by error because his plasma indomethacin level was 690 ngm/ml (levels were obtained in 24/30 study infants 1 hour after the last dose of indomethacin or placebo). If this infant is reassigned to the indomethacin group, the adjusted incidence of CP is 6/13 in indomethacin treated infants and 0/11 in placebo treated infants (p=0.02, Fisher's Exact). Other patient characteristics and outcomes are shown in the Table. Speculation: This data raises concern that early indomethacin may cause cerebral palsy. Results from other trials of early indomethacin are needed to confirm or refute the observations in this study.

Table 1 No caption available.
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