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Results From the Trial of Indomethacin Prophylaxis in Preterms

Barbara Schmidt, MD, MSc; Elizabeth V. Asztalos, MD, MSc; Robin S. Roberts, MSc; Charlene M. T. Robertson, MD; Reginald S. Sauve, MD; Michael F. Whitfield, MD; for the Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators

JAMA. 2003;289:1124-1129.

Context  Despite more than 2 decades of outcomes research after very preterm birth, clinicians remain uncertain about the extent to which neonatal morbidities predict poor long-term outcomes of extremely low-birth-weight (ELBW) infants.

Objective  To determine the individual and combined prognostic effects of bronchopulmonary dysplasia (BPD), ultrasonographic signs of brain injury, and severe retinopathy of prematurity (ROP) on 18-month outcomes of ELBW infants.

Design  Inception cohort assembled for the Trial of Indomethacin Prophylaxis in Preterms (TIPP).

Setting and Participants  A total of 910 infants with birth weights of 500 to 999 g who were admitted to 1 of 32 neonatal intensive care units in Canada, the United States, Australia, New Zealand, and Hong Kong between 1996 and 1998 and who survived to a postmenstrual age of 36 weeks.

Main Outcome Measures  Combined end point of death or survival to 18 months with 1 or more of cerebral palsy, cognitive delay, severe hearing loss, and bilateral blindness.

Results  Each of the neonatal morbidities was similarly and independently correlated with a poor 18-month outcome. Odds ratios were 2.4 (95% confidence interval [CI], 1.8-3.2) for BPD, 3.7 (95% CI, 2.6-5.3) for brain injury, and 3.1 (95% CI, 1.9-5.0) for severe ROP. In children who were free of BPD, brain injury, and severe ROP the rate of poor long-term outcomes was 18% (95% CI, 14%-22%). Corresponding rates with any 1, any 2, and all 3 neonatal morbidities were 42% (95% CI, 37%-47%), 62% (95% CI, 53%-70%), and 88% (64%-99%), respectively.

Conclusion  In ELBW infants who survive to a postmenstrual age of 36 weeks, a simple count of 3 common neonatal morbidities strongly predicts the risk of later death or neurosensory impairment.

Author Affiliations: Departments of Pediatrics (Dr Schmidt) and Clinical Epidemiology and Biostatistics (Dr Schmidt and Mr Roberts), McMaster University, Hamilton, Ontario; Department of Pediatrics, University of Toronto, Toronto, Ontario (Dr Asztalos); Child Health Outcomes Unit, Glenrose Rehabilitation Hospital, Edmonton, Alberta (Dr Robertson); Departments of Pediatrics and Community Health Sciences, University of Calgary, Calgary, Alberta (Dr Sauve) and Department of Department of Pediatrics, University of British Columbia, Vancouver (Dr Whitfield).

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