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Randomized Control ...
Randomized Control Trial of Postnatal rhIGF-1/rhIGFBP-3 Replacement in Preterm Infants: Post-hoc Analysis of Its Effect on Brain Injury
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- Horsch, S. (author)
- Karolinska Institute,HELIOS Klinikum Berlin-Buch,Harvard University,Boston Children's Hospital
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- Parodi, A. (author)
- Gaslini Children's Hospital
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- Hallberg, B. (author)
- Karolinska Institutet,Karolinska Institute
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- Björkman-Burtscher, Isabella M. (author)
- Gothenburg University,Göteborgs universitet,University of Gothenburg,Lund University,Lunds universitet,Neuroradiologi,Forskargrupper vid Lunds universitet,Neuroradiology,Lund University Research Groups,Skåne University Hospital,Institutionen för kliniska vetenskaper, Avdelningen för radiologi,Institute of Clinical Sciences, Department of Radiology
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- Björkman-Burtscher, Isabella (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för radiologi,Institute of Clinical Sciences, Department of Radiology
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- Hansen-Pupp, Ingrid (author)
- Lund University,Lunds universitet,Neonatalogi,Forskargrupper vid Lunds universitet,Neonatology,Lund University Research Groups,Skåne University Hospital
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- Marlow, N. (author)
- University College London
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- Beardsall, K. (author)
- University of Cambridge
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- Dunger, D. (author)
- University of Cambridge
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- van Weissenbruch, M. (author)
- Amsterdam UMC - Vrije Universiteit Amsterdam
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Smith, L. E. H. (author)
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- Hamdani, M. (author)
- Takeda Pharmaceutical Company Ltd, US
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- Mangili, A. (author)
- Takeda Pharmaceutical Company Ltd, US
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- Barton, N. (author)
- Takeda Pharmaceutical Company Ltd, US
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- Ramenghi, L. A. (author)
- University of Genoa,Gaslini Children's Hospital
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- Hellström, Ann, 1959 (author)
- University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology
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- Ley, David (author)
- Lund University,Lunds universitet,Neonatalogi,Forskargrupper vid Lunds universitet,Neonatology,Lund University Research Groups,Skåne University Hospital
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(creator_code:org_t)
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- 2020-10-09
- 2020
- English.
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In: Frontiers in Pediatrics. - : Frontiers Media SA. - 2296-2360. ; 8
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Keyword
- neonate
- brain injury
- cerebral hemorrhage
- recombinant human IGF-1
- extremely preterm
- intraventricular hemorrhage
- premature-infants
- neurodevelopmental
- outcomes
- ultrasound
- children
- therapy
- term
- mri
- Pediatrics
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Horsch, S.
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Parodi, A.
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Hallberg, B.
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Björkman-Burtsch ...
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Björkman-Burtsch ...
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Hansen-Pupp, Ing ...
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Marlow, N.
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Beardsall, K.
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Dunger, D.
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van Weissenbruch ...
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Smith, L. E. H.
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Hamdani, M.
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Mangili, A.
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Barton, N.
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Ramenghi, L. A.
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Hellström, Ann, ...
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Ley, David
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Pediatrics
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
- Articles in the publication
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Frontiers in Ped ...
- By the university
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University of Gothenburg
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Lund University
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Karolinska Institutet