CLOSURE OF A HEMODYNAMICALLY SIGNIFICANT PDA WITH INDOMETHACIN IN PRETERM INFANTS UNDER 1000 G

Background: Efficiency and side effects of indomethacin therapy for cl osure of a hemodynamically significant PDA in extremely pre mature inf ants under 1000 g was investigated in a prospective clinical trial. Me thod: Clinical, two-dimensional-echocardiographic and Doppler-sonograp hic findings were used to assess the hemodynamic significance of PDA. After an i.v. fluid substitution of 6-7 ml/kg x h for 6h we administer ed 3 doses of 0.2 mg/kg indomethacin (Vonum) intramuscularly at 12 hou r intervals, followed by a maintenance dose of 0.1 mg/kg at 24 hour in tervals for at most 5 days. Treatment was discontinued as soon as the PDA was closed. If there was no therapeutic effect at all after the th ird administration of indomethacin, a surgical PDA ligation was perfor med with no further delay. Results: Between January 1990 and December 1991 30 preterm infants under 1000 g (mean birth weight 855 g, +/- 120 g) fulfilled the therapy criteria. The first indomethacin administrat ion on average took place on the 7th (+/-4) day of life, the whole tre atment on average lasted 4.4 (+/-2) days. In 25 patients (83 %) PDA cl osure occurred under therapy, the other 5 patients without sufficient therapeutic success were treated by surgical PDA ligation on the secon d or third day after the beginning of therapy. The indomethacin treatm ent was well tolerated by the patients, renal failure (diuresis less t han 1 ml/kg x h) occurred in only 3 infants all of whom improved quick ly after frusemide therapy. No further complications were observed tha t could directly be related to indomethacin treatment. Three of the pr eterm infants died later on because of peritonitis after gastric perfo ration, necrotizing enterocolitis and fungal septicaemia respectively. Conclusion: Indomethacin treatment of PDA is an effective and well-to lerated alternative to surgical ligation even in extremely premature p reterm infants.