Clinical course to 1 year of age in premature infants with patent ductus arteriosus: results of a multicenter randomized trial of indomethacin.

Reported are 1-year follow-up results of a randomized clinical trial comparing three strategies of managing clinically significant patent ductus arteriosus at the time of diagnosis in premature infants: (1) immediate administration of a three-dose course of intravenously administered indomethacin in addition to usual medical therapy (fluid restriction and use of diuretics or digitalis or both), with surgery as a backup measure, (2) usual medical therapy alone initially, with indomethacin as the first and surgery as the final backup measure, and (3) usual medical therapy alone initially, with surgery alone as backup. Of primary concern were the relative merits of these three managements strategies in the terms of the long-term occurrence of a wide range of health problems. Although at the time of neonatal hospitalization there was a significant excess of bleeding episodes in infants receiving indomethacin as part of initial treatment, and a significantly higher rate of retrolental fibroplasia in the those given usual medical therapy with surgery as backup, there were no statistically significant differences at 1 year of age related to these intermediate outcomes. In other regards, too, the treatment strategies appeared interchangeable in terms of the 1-year outcome.

Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study.

Among 3559 newborn infants with birth weight less than 1750 gm, 421 developing a hemodynamically significant patent ductus arteriosus were entered into a randomized trial to evaluate the role of indomethacin in the management of PDA. Indomethacin given concurrently with usual medical therapy at the time of diagnosis resulted in ductal closure in 79%, versus 35% with placebo (P less than 0.001). Indomethacin as backup to usual medical treatment resulted in similar closure rates. To assess overall effects through hospital discharge, three management strategies were compared. Although mortality did not differ significantly, infants given indomethacin only if usual therapy failed (strategy 2) had a lower incidence of bleeding than those to whom indomethacin was given with initial medical therapy (strategy 1) and lower rates of pneumothorax and retrolental fibroplasia than those to whom no indomethacin was administered, with surgery the only backup to medical therapy (strategy 3). Thus the administration of indomethacin only when medical treatment fails appears to be the preferable approach for the management of symptomatic PDA in premature infants.

The use of prostaglandin E1 in an infant with interruption of the aortic arch.

Infusion of prostaglandin E1 into the main pulmonary artery of an infant with interruption of the aortic arch and a closing ductus arteriosus resulted in dilation of the ductus arteriosus and improved systemic perfusion. Treatment with prostaglandin E1 is recommended for infants with interruption of the aortic arch, critical coarctation of the aorta, and other lesions in which systemic perfusion is limited by a restrictive ductus arteriosus.

Sepsis and congenital asplenia.

Fifty-nine children with congenital asplenia were reviewed for episodes of severe infection. Seven children had isolated asplenia and 52 had asplenia associated with complex congenital heart disease (asplenia syndrome). A control group of eusplenic children with comparable cardiac lesions were assembled and used for comparative statistical analysis. There were 16 instances of documented sepsis among 59 children (27%). In those less than six months of age, the invading organism was usually gram-negative (Escherichia coli or Klebsiella). In children six months of age or older, the infecting organism was usually a pneumococcus or H. influenzae. When those with asplenia syndrome were compared to the control population, the former group had a significantly greater incidence of sepsis. Children with asplenia syndrome who survived the first month of life were at greater risk of dying from sepsis than from their heart disease. It is recommended that prophylactic antibiotics be administered to children with congenital absence of the spleen, commencing at three months of age, to be continued indefinitely.