Evidence map›Paper›PMID 23095978›Full record

Trial reportPediatric research2013

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.

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 and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Pediatric research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01096784 (Determination of the rhIGF-1/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-1 Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity A Phase 2, Randomized Controlled, Assessor-blind, Dose Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study), which is not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01096784 phase2completednot on this map

Determination of the rhIGF-1/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-1 Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity A Phase 2, Randomized Controlled, Assessor-blind, Dose Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study

TypeinterventionalSponsorShireRan2010 to 2016Enrolled121ConditionsRetinopathy of Prematurity (ROP)ArmsrhIGF-I/rhIGFBP-3
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 66 citations in OpenAlex.

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  6. [Advances in pharmacological research for retinopathy of prematurity].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

David LeyDepartment of Pediatrics, Institution of Clinical Sciences, Lund University, Lund, Sweden. david.ley@med.lu.se
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
University of Gothenburg · SELund University · SEBoston Children's Hospital · USUmeå University · SEUppsala University · SE

Funding

Dietary control of angiogenesis in retinopathy modelsR01EY017017 · NEI · BOSTON CHILDREN'S HOSPITAL · PI Zhongjie Fu, Lois Smith · 2006 to 2026
$11.8M
Neuronal guidance molecules control revascularization in retinopathyR01EY022275 · NEI · BOSTON CHILDREN'S HOSPITAL · PI SMITH, LOIS · 2012 to 2014
$1.3M
NEI NIH HHS R01 EY017017NEI NIH HHS R01 EY022275
6 · The paper itself

Abstract

backgroundIn 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.

methodsIn 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.

resultsTreatment 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.

conclusionIn 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.

Indexed as

BrainFemaleHumansInfant, Extremely PrematureInfant, NewbornInfusions, IntravenousInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IMaleRetinopathy of PrematuritySwedenInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor I

Identifiers

PMID23095978
PMCPMC4028624
OpenAlexW2058670430

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.