PMID- 23095978
OWN - NLM
STAT- MEDLINE
DCOM- 20130611
LR  - 20211021
IS  - 1530-0447 (Electronic)
IS  - 0031-3998 (Print)
IS  - 0031-3998 (Linking)
VI  - 73
IP  - 1
DP  - 2013 Jan
TI  - 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.
PG  - 68-74
LID - 10.1038/pr.2012.146 [doi]
AB  - 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 microg/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 microg/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.
FAU - Ley, David
AU  - Ley D
AD  - Department of Pediatrics, Institution of Clinical Sciences, Lund University, 
      Lund, Sweden. david.ley@med.lu.se
FAU - Hansen-Pupp, Ingrid
AU  - Hansen-Pupp I
FAU - Niklasson, Aimon
AU  - Niklasson A
FAU - Domellof, Magnus
AU  - Domellof M
FAU - Friberg, Lena E
AU  - Friberg LE
FAU - Borg, Jan
AU  - Borg J
FAU - Lofqvist, Chatarina
AU  - Lofqvist C
FAU - Hellgren, Gunnel
AU  - Hellgren G
FAU - Smith, Lois E H
AU  - Smith LE
FAU - Hard, Anna-Lena
AU  - Hard AL
FAU - Hellstrom, Ann
AU  - Hellstrom A
LA  - eng
SI  - ClinicalTrials.gov/NCT01096784
GR  - R01 EY017017/EY/NEI NIH HHS/United States
GR  - R01 EY022275/EY/NEI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20121024
PL  - United States
TA  - Pediatr Res
JT  - Pediatric research
JID - 0100714
RN  - 0 (Insulin-Like Growth Factor Binding Protein 3)
RN  - 67763-96-6 (Insulin-Like Growth Factor I)
SB  - IM
MH  - Brain/*growth & development/metabolism
MH  - Female
MH  - Humans
MH  - Infant, Extremely Premature
MH  - Infant, Newborn
MH  - Infusions, Intravenous
MH  - Insulin-Like Growth Factor Binding Protein 3/administration & 
      dosage/*blood/*pharmacokinetics
MH  - Insulin-Like Growth Factor I/administration & 
      dosage/*metabolism/*pharmacokinetics
MH  - Male
MH  - Retinopathy of Prematurity/*prevention & control
MH  - Sweden
PMC - PMC4028624
MID - NIHMS575411
EDAT- 2012/10/26 06:00
MHDA- 2013/06/12 06:00
PMCR- 2014/05/21
CRDT- 2012/10/26 06:00
PHST- 2012/10/26 06:00 [entrez]
PHST- 2012/10/26 06:00 [pubmed]
PHST- 2013/06/12 06:00 [medline]
PHST- 2014/05/21 00:00 [pmc-release]
AID - pr2012146 [pii]
AID - 10.1038/pr.2012.146 [doi]
PST - ppublish
SO  - Pediatr Res. 2013 Jan;73(1):68-74. doi: 10.1038/pr.2012.146. Epub 2012 Oct 24.