Trial reportThe Journal of pediatrics2019
rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial.
Trial report in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 97 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Determination of the rhIGF-1/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-1 Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity A Phase 2, Randomized Controlled, Assessor-blind, Dose Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study
A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity
Who cites it
97 citing papers in PubMed, 4 syntheses or guidelines pooled it, 152 citations in OpenAlex.
- Placental hormones, IGF-1, and early-life growth: endocrine links between birth size and infant metabolic programming-a systematic review.European journal of pediatrics · 2026Pooled it
- Guideline
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Pooled it
- An exploratory study of clinical factors associated with IGF-1 and IGFBP-3 in preterm infants.Pediatric research · 2024Trial
- Trial
- Body composition and neuromotor development in the year after NICU discharge in premature infants.Pediatric research · 2020Trial
- Review
- Bronchopulmonary dysplasia and prematurity-associated lung disease: emerging therapies to improve lifelong respiratory outcomes.European journal of pediatrics · 2026Review
- Translational Development of Physiologic IGF-1 Replacement for the Prevention of Bronchopulmonary Dysplasia.Biomedicines · 2026Article
- Preventive application of lung growth factors and lack of attenuation of phenotype disruption of lung resident MSC from preterm infants by hyperoxia.Molecular and cellular pediatrics · 2026Article
- A critical moment for neonatology: appeals from the Lancet Child & Adolescent Health Commission.Italian journal of pediatrics · 2026Article
- Randomised Phase 2b trial of rhIGF-1/rhIGFBP-3 (OHB-607) for bronchopulmonary dysplasia prevention in preterm neonates: study protocolBMJ paediatrics open · 2026Article
- Recombinant human IGF-1 alleviates dyslipidemia induced by lactational maternal dietary restriction.Frontiers in pediatrics · 2026Article
- Unfolded protein response in bronchopulmonary dysplasia: mechanisms, pathways, and therapeutic implications.Frontiers in cell and developmental biology · 2026Review
- Promising Preventive Strategies for Intraventricular Hemorrhage in Preterm Neonates: A Critical Review.Journal of clinical medicine · 2025Review
- Current and Emerging Therapies for Prevention and Treatment of Bronchopulmonary Dysplasia in Preterm Infants.Paediatric drugs · 2025Review
- Association of early postnatal decline in fetal hemoglobin with bronchopulmonary dysplasia in very low birth weight infants: a cohort study.BMC pregnancy and childbirth · 2025Article
- Resolvin D1 improves bleomycin-induced alveolar maturation arrest in newborn rats.Scientific reports · 2025Article
- Targeting adenosine APurinergic signalling · 2025Review
37 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors at 17 institutions in 5 countries.
Funding
Abstract
objectiveTo 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
designThis phase 2 trial was conducted from September 2014 to March 2016. Infants born at a gestational age of 23
resultsOverall, 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.
conclusionsrhIGF-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 registrationClinicalTrials.gov: NCT01096784.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.