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rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial

Journal article
Authors David Ley
Boubou Hallberg
Ingrid Hansen-Pupp
Carlo Dani
Luca A. Ramenghi
Neil Marlow
Kathryn Beardsall
Faizah Bhatti
David Dunger
Jason D. Higginson
Ajit Mahaveer
Olachi J. Mezu-Ndubuisi
Peter Reynolds
Carmen Giannantonio
Mirjam van Weissenbruch
Norman Barton
Adina Tocoian
Mohamed Hamdani
Emily Jochim
Alexandra Mangili
Jou Ku Chung
Mark A. Turner
Lois E.H. Smith
Ann Hellström
Published in Journal of Pediatrics
Volume 206
Pages 56-65.e8
ISSN 0022-3476
Publication year 2019
Published at Institute of Neuroscience and Physiology, Department of Clinical Neuroscience
Pages 56-65.e8
Language en
Keywords bronchopulmonary dysplasia, intraventricular hemorrhage, neonatology, retinopathy of prematurity
Subject categories Pediatrics

Abstract

© 2018 The Author(s) Objective: To investigate recombinant human insulin-like growth factor 1 complexed with its binding protein (rhIGF-1/rhIGFBP-3) for the prevention of retinopathy of prematurity (ROP) and other complications of prematurity among extremely preterm infants. Study design: This phase 2 trial was conducted from September 2014 to March 2016. Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from <24 hours of birth to postmenstrual age 296/7 weeks) or standard neonatal care, with follow-up to a postmenstrual age of 404/7 weeks. Target exposure was ≥70% IGF-1 measurements within 28-109 µg/L and ≥70% intended therapy duration. The primary endpoint was maximum severity of ROP. Secondary endpoints included time to discharge from neonatal care, bronchopulmonary dysplasia, intraventricular hemorrhage, and growth measures. Results: Overall, 61 infants were allocated to rhIGF-1/rhIGFBP-3, 60 to standard care (full analysis set); 24 of 61 treated infants achieved target exposure (evaluable set). rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence. There was, however, a 53% decrease in severe bronchopulmonary dysplasia in the full analysis set (21.3% treated vs 44.9% standard care), and an 89% decrease in the evaluable set (4.8% vs 44.9%; P = .04 and P = .02, respectively) for severity distribution between groups. There was also a nonsignificant trend toward decrease in grades 3-4 intraventricular hemorrhage in the full analysis set (13.1% vs 23.3%) and in the evaluable set (8.3% vs 23.3%). Fatal serious adverse events were reported in 19.7% of treated infants (12/61) and 11.7% of control infants (7/60). No effect was observed on time to discharge from neonatal care/growth measures. Conclusions: rhIGF-1/rhIGFBP-3 did not affect development of ROP, but decreased the occurrence of severe bronchopulmonary dysplasia, with a nonsignificant decrease in grades 3-4 intraventricular hemorrhage. Trial registration: ClinicalTrials.gov: NCT01096784.

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