Original articleNeurosensory Impairment after Surgical Closure of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants: Results from the Trial of Indomethacin Prophylaxis in Preterms
Section snippets
Patients
Infants with birth weights between 500 and 999 g were enrolled in the TIPP study between January 1996 and March 1998.3 The research ethics boards of all clinical centers in Canada, the United States, Australia, New Zealand, and Hong Kong approved the trial protocol, and written informed consent was obtained from a parent or guardian of each infant. Participating neonatal intensive care units were located either in tertiary care maternity hospitals or in tertiary care children’s hospitals.
Study Cohort and Status at First Diagnosis of PDA
Of the 1202 infants who were enrolled in the TIPP study, 9 infants died on their calendar day of birth. Adequate data for analysis of the composite outcome at 18 months were available for 1134 of the remaining 1193 infants (95%). There were 708 infants (62%) without a symptomatic PDA, 316 infants (28%) with PDA who were treated without surgery, and 110 infants (10%) who underwent PDA ligation. Table I shows the baseline characteristics of the infants and their mothers for the 2 subgroups of
Discussion
In this large international cohort of ELBW infants, surgical closure of a PDA was a strong risk factor for neurosensory impairment at 18 months. Compared with infants whose PDA was treated without surgery, infants who underwent PDA ligation also had increased risks of BPD and of severe ROP. Deaths appeared to be less common in infants who underwent PDA ligation than in infants in the comparison group. This may represent a true beneficial effect of surgical PDA closure on survival, in keeping
References (24)
- et al.
Management of patent ductus arteriosus: a comparison of operative v pharmacologic treatment
J Pediatr Surg
(1987) - et al.
Optimal management of patent ductus arteriosus in the neonate weighing less than 800 g
J Pediatr Surg
(1993) - et al.
Patent ductus arteriosus in micropreemies and full-term infants: the relative merits of surgical ligation versus indomethacin treatment
J Pediatr Surg
(2003) - et al.
Is surgical ligation of a patent ductus arteriosus the preferred initial approach for the neonate with extremely low birth weight?
J Pediatr Surg
(1996) - et al.
Interruption of patent ductus arteriosus in premature infants with respiratory distress syndrome
Ann Thorac Surg
(1976) - et al.
Randomized trial of early closure of symptomatic patent ductus arteriosus in small preterm infants
J Pediatr
(1978) - et al.
Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study
J Pediatr
(1983) Surgery and the tiny baby: sensorineural outcome at 5 years of age
J Paediatr Child Health
(1996)Outcome at 5 years of age of children 23 to 27 weeks’ gestation: refining the prognosis
Pediatrics
(2001)- et al.
Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants
N Engl J Med
(2001)
Impact of BPD, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the Trial of Indomethacin Prophylaxis in Preterms
JAMA
Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period
Pediatrics
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Supported by the Medical Research Council of Canada MT-13288. US centers were supported in part by grants from the National Institute of Child Health and Human Development (D U10 HD21364, U10 HD27851, U10 HD21373, U10 HD27881; M01 RR 00997, U10 HD27880; M01 RR 00070, U10 HD21385, U10 HD27904, U10 HD34216). INDOCID P.D.A. was donated by Merck Frosst.
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Other members of the study group are listed in the Appendix available at www.jpeds.com.