Randomized Control Trial of Postnatal rhIGF-1/rhIGFBP-3 Replacement in Preterm Infants

Autor: Sandra, Horsch, Alessandro, Parodi, Boubou, Hallberg, Mariya, Malova, Isabella M, Björkman-Burtscher, Ingrid, Hansen-Pupp, Neil, Marlow, Kathryn, Beardsall, David, Dunger, Mirjam, van Weissenbruch, Lois E H, Smith, Mohamed, Hamdani, Alexandra, Mangili, Norman, Barton, Luca A, Ramenghi, Ann, Hellström, David, Ley
Rok vydání: 2019
Předmět:
Zdroj: Frontiers in Pediatrics
ISSN: 2296-2360
Popis: 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
Databáze: OpenAIRE