Abstract
To assess the efficacy of prophylactic indomethacin [I] in preventing clinically significant patent ductus arteriosus (PDA), 61 infants were prospectively randomized by birth weight (Group A: <900 g; Group B: 900-1300 g) to receive either placebo [P] or [I] intravenously. The first dose (0.2 mg/kg), given within 12 hours of birth, was followed by two q12 hourly doses (0.1 mg/kg). Investigators were unaware of the study drug given. PDA was considered clinically significant if a murmur and/or positive 2-D Doppler was associated with two of four additional findings: bounding pulses, hyperdynamic precordium, pulmonary plethora, or failure to wean from mechanical ventilation within 48 hours. After the initial course of prophylactic [I] or [P], therapeutic [I] was prescribed for clinically significant PDA unless contraindicated.
Prophylactic [I] appeared efficacious in preventing significant PDA in premature infants < 900 grams; however, [I] resulted in no significant impact upon intensity or duration of oxygen requirements or survival.
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Setzer, E., Torres-Arraut, E., Gomez-Del-Rio, M. et al. CARDIOPULMONARY EFFECTS OF PROPHYLACTIC INDOMETHACIN IN THE VERY-LOW-BIRTH-WEIGHT INFANT. Pediatr Res 18 (Suppl 4), 346 (1984). https://doi.org/10.1203/00006450-198404001-01517
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DOI: https://doi.org/10.1203/00006450-198404001-01517