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Randomized Control Trial of Postnatal rhIGF-1/rhIGFBP-3 Replacement in Preterm Infants: Post-hoc Analysis of Its
Sandra Horsch1,2, Alessandro Parodi3, Boubou Hallberg2
1HELIOS Klinikum Berlin-Buch, Berlin, Germany.
Insights
Postnatal insulin-like growth factor-1/IGF binding protein-3 (rhIGF-1/rhIGFBP-3) showed a trend toward reducing brain injury in preterm infants. The protective effect was most evident in infants without germinal matrix hemorrhage/intraventricular hemorrhage at treatment initiation.
Area of Science:
- Neonatology
- Pediatric Neurology
- Endocrinology
Background:
- Prematurity is associated with significant comorbidities, including brain injury.
- Postnatal insulin-like growth factor-1 (IGF-1) replacement therapy is being investigated to mitigate these risks.
- A previous phase II trial evaluated recombinant human IGF-1/IGF binding protein-3 (rhIGF-1/rhIGFBP-3) in extremely preterm infants.
Purpose of the Study:
- To conduct a post-hoc analysis of cranial ultrasound (CUS) data from a phase II trial.
- To evaluate the effect of rhIGF-1/rhIGFBP-3 on the incidence of various types of brain injury in extremely preterm infants.
Main Methods:
- Exploratory post-hoc analysis of a phase II randomized controlled trial (NCT01096784).
- Infants (<28 weeks gestational age) received either rhIGF-1/rhIGFBP-3 or standard of care (SOC).
- Serial CUS were performed, and germinal matrix hemorrhage/intraventricular hemorrhage (GMH-IVH), periventricular hemorrhagic infarction (PHI), and white matter injury (WMI) were assessed.
Main Results:
- A trend towards reduced grade II-III GMH-IVH and PHI was observed in the rhIGF-1/rhIGFBP-3 group compared to SOC.
- In infants without baseline GMH-IVH, treated infants showed reduced progression to GMH-IVH (25.0% vs. 40.4%), though not statistically significant.
- No significant effects of rhIGF-1/rhIGFBP-3 on white matter injury were detected.
Conclusions:
- Postnatal rhIGF-1/rhIGFBP-3 may offer a protective effect against GMH-IVH/PHI in extremely preterm infants.
- This potential benefit appears most pronounced in infants without evidence of GMH-IVH at the start of treatment.
- Further research is warranted to confirm these findings and elucidate the mechanisms of action.
Abstract:
Background: Postnatal insulin-like growth factor-1 (IGF-1) replacement with recombinant human (rh)IGF-1 and IGF binding protein-3 (rhIGF-1/rhIGFBP-3) is being studied as a potential treatment to reduce comorbidities of prematurity. We have recently reported on a phase II, multicenter, randomized, controlled trial comparing postnatal rhIGF-1/rhIGFBP-3 replacement with standard of care (SOC) in extremely preterm infants (NCT01096784). Maximum severity of retinopathy of prematurity was the primary endpoint of the trial and presence of GMH-IVH/PHI one of the pre-specified secondary endpoints. Infants therefore received serial cranial ultrasound scans (CUS) between birth and term age. In this post-hoc analysis we present a detailed analysis of the CUS data of this trial and evaluate the effect of postnatal rhIGF-1/rhIGFBP-3 replacement on the incidence of different kinds of brain injury in extremely preterm infants. Methods: This report is an exploratory post-hoc analysis of a phase II trial in which infants <28 weeks gestational age were randomly allocated to rhIGF-1/rhIGFBP-3 or SOC. Serial cranial ultrasounds were performed between birth and term-equivalent age. Presence of germinal matrix hemorrhage and intraventricular hemorrhage (GMH-IVH), periventricular hemorrhagic infarction (PHI), post-hemorrhagic ventricular dilatation, and white matter injury (WMI) were scored by two independent masked readers. Results: The analysis included 117 infants; 58 received rhIGF-1/rhIGFBP-3 and 59 received SOC. A trend toward less grade II-III GMH-IVH and PHI was observed in treated infants vs. SOC. A subanalysis of infants without evidence of GMH-IVH at study entry (n = 104) showed reduced progression to GMH-IVH in treated infants (25.0% [13/52] vs. 40.4% [21/52]; not significant). No effects of rhIGF-1/rhIGFBP-3 on WMI were observed. Conclusion: The potential protective effect of rhIGF-1/rhIGFBP-3 on the occurrence of GMH-IVH/PHI appeared most pronounced in infants with no evidence of GMH-IVH at treatment start.
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