Document Detail


Longitudinal infusion of a complex of insulin-like growth factor-I and IGF-binding protein-3 in five preterm infants: pharmacokinetics and short-term safety.
MedLine Citation:
PMID:  23095978     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In preterm infants, low levels of insulin-like growth factor-I (IGF-I) and IGF binding protein 3 (IGFBP-3) are associated with impaired brain growth and retinopathy of prematurity (ROP). Treatment with IGF-I/IGFBP-3 may be beneficial for brain development and may decrease the prevalence of ROP.
METHODS: In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3. Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
RESULTS: Treatment with rhIGF-I/rhIGFBP-3 was associated with higher serum IGF-I and IGFBP-3 concentrations (P < 0.001) than model-predicted endogenous levels. Of 74 IGF-I samples measured during study drug infusion, 37 (50%) were within the target range, 4 (5%) were above, and 33 (45%) were below. The predicted dose of rhIGF-I/rhIGFBP-3 required to establish circulating levels of IGF-I within the intrauterine range in a 1,000 g infant was 75-100 µg/kg/24 h. No hypoglycemia or other adverse effects were recorded.
CONCLUSION: In this study, continuous intravenous infusion of rhIGF-I/rhIGFBP-3 was effective in increasing serum concentrations of IGF-I and IGFBP-3, and was found to be safe.
Authors:
David Ley; Ingrid Hansen-Pupp; Aimon Niklasson; Magnus Domellöf; Lena E Friberg; Jan Borg; Chatarina Löfqvist; Gunnel Hellgren; Lois E H Smith; Anna-Lena Hård; Ann Hellström
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-10-24
Journal Detail:
Title:  Pediatric research     Volume:  73     ISSN:  1530-0447     ISO Abbreviation:  Pediatr. Res.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-08     Completed Date:  2013-06-11     Revised Date:  2014-04-08    
Medline Journal Info:
Nlm Unique ID:  0100714     Medline TA:  Pediatr Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  68-74     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01096784
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MeSH Terms
Descriptor/Qualifier:
Brain / growth & development*,  metabolism
Female
Humans
Infant, Extremely Premature
Infant, Newborn
Infusions, Intravenous
Insulin-Like Growth Factor Binding Protein 3 / administration & dosage,  blood*,  pharmacokinetics*
Insulin-Like Growth Factor I / administration & dosage,  metabolism*,  pharmacokinetics*
Male
Retinopathy of Prematurity / prevention & control*
Sweden
Chemical
Reg. No./Substance:
0/Insulin-Like Growth Factor Binding Protein 3; 67763-96-6/Insulin-Like Growth Factor I

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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