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

ABSTRACT:

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 23^0/7 weeks to 27^6/7 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 29^6/7 weeks) or standard neonatal care, with follow-up to a postmenstrual age of 40^4/7 weeks. Target exposure was ≥70% IGF-1 measurements within 28-109 µg/L and ≥70% intended therapy duration. The p

SUBMITTER: Ley D 

PROVIDER: S-EPMC6389415 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature