Neurodevelopmental (ND) Follow-Up at Three Years Corrected Age (CA) of Extremely Preterm Infants Treated with Prophylactic Indomethacin in the First 24 Hours of Life for the Prevention of Patent Ductus Arteriosus (PDA)

Abstract 1121 Neonatology: Clinical Studies in the Premature Infant Platform, Tuesday, 5/4

Prophylactic indomethacin (0.1mg/kg/dose, q24H × 6 days) initiated within the first 24 hours of life promoted closure of PDA in 90 preterm infants with birthweight (BW) between 600-1250 grams and gestational age (GA) between 23-29 weeks in a prospective, randomized, controlled trial (J Pediatr 1996; 128: 631-7). 46 of 47 placebo infants and 42 of 43 indomethacin infants survived. Because previous reports suggested indomethacin decreases cerebral blood flow and may play a role in the development of ischemic brain injury and developmental handicaps (J Pediatr 1991; 118: 112-5 and Lancet 1990; 335: 1491-95), 66 of 88 (75%) survivors were seen for ND follow-up at three years CA. Neurodevelopmental outcome was categorized as follows: Normal: no significant abnormalities on physical and/or neurological exam and developmental testing scores on the Bayley Scales of Infant Development < 1 SD below the mean; Mild to Moderately Abnormal: isolated muscle tone abnormalities, strabismus, unilateral blindness, hyperactivity and/or developmental testing scores between 1 and 2 SD below the mean; Impaired: blindness, spasticity, deafness, hydrocephalus, and/or severe delay with developmental testing scores more than 2 SD below the mean.

RESULTS: There were no significant differences in BW, GA, sex, % inborn, antenatal steroid administration, C/Section rate, race, Apgar scores and diagnosis between the two groups seen at ND follow-up. Neurodevelopmental outcome of the 66 infants is shown in the table below: (HC=head circumference)

Table 1 No caption

Analysis based on ordered logistic regression, controlling for GA, also indicates a higher risk of adverse neurodevelopmental outcome for placebo-treated infants than for those given indomethacin, with an odds ratio of 1.64 (95% CI, 0.53 to 5.26; p value not significant).

CONCLUSION: Prophylactic indomethacin administered in the first 24 hours of life for the prevention of PDA does not result in adverse neurodevelopmental outcome at approximately three years corrected age.