Evidence map›Paper›PMID 19190540›Full record

Trial reportPediatric research2009

A pharmacokinetic and dosing study of intravenous insulin-like growth factor-I and IGF-binding protein-3 complex to preterm infants.

Chatarina Löfqvist, Aimon Niklasson, Eva Engström, Lena E Friberg, Cecilia Camacho-Hübner, David Ley, Jan Borg, Lois E H Smith, Ann Hellström

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

Trial report in Pediatric research, 2009. 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 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.6field-weighted citation impact, top 6% 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 mapstarted 2010, after this paper: background citation

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

25 citing papers in PubMed, 60 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Elevated levels of IL-6 and IGFBP-1 predict low serum IGF-1 levels during continuous infusion of rhIGF-1/rhIGFBP-3 in extremely preterm infants.Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2020
    Article
  11. Review
  12. Article
  13. The role of serum apelin in retinopathy of prematurity.Clinical ophthalmology (Auckland, N.Z.) · 2017
    Article
  14. Review
  15. Review
  16. Retinopathy of prematurity: Past, present and future.World journal of clinical pediatrics · 2016
    Review
  17. Review
  18. Retinopathy of prematurity.Lancet (London, England) · 2013
    Review
  19. An ocular view of the IGF-IGFBP system.Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2013
    Review
  20. Article
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

9 authors at 5 institutions in 2 countries.

Chatarina LöfqvistDepartment of Ophthalmology, Sahlgrenska Academy at Gothenburg University, Göteborg 416 85, Sweden.
Aimon Niklasson
Eva Engström
Lena E Friberg
Cecilia Camacho-Hübner
David Ley
Jan Borg
Lois E H Smith
Ann Hellström
University of Gothenburg · SEHarvard University · USKarolinska Institutet · SELund University · SEUppsala University · SE

Funding

SYNAPTIC MECHANISMS IN HIPPOCAMPAL EPILEPTOGENESISP30HD018655 · NICHD · CHILDREN'S HOSPITAL BOSTON · PI POMEROY, SCOTT LOREN · 1985 to 2015
$26.2M
Dietary control of angiogenesis in retinopathy modelsR01EY017017 · NEI · BOSTON CHILDREN'S HOSPITAL · PI Zhongjie Fu, Lois Smith · 2006 to 2026
$11.8M
VASCULAR CELL IMMATURITY IN RETINOPATHY OF PREMATURITYR01EY008670 · NEI · CHILDREN'S HOSPITAL BOSTON · PI SMITH, LOIS · 1992 to 2007
$3.9M
Neuronal guidance molecules control revascularization in retinopathyR01EY022275 · NEI · BOSTON CHILDREN'S HOSPITAL · PI SMITH, LOIS · 2012 to 2014
$1.3M
Surrogate Markers for Early Stage Diabetic RetinopathyR21EY014811 · NEI · CHILDREN'S HOSPITAL BOSTON · PI SMITH, LOIS · 2002 to 2003
$398k
NEI NIH HHS EY008670NEI NIH HHS EY14811NEI NIH HHS R01 EY008670NEI NIH HHS R01 EY017017NEI NIH HHS R01 EY022275NEI NIH HHS R21 EY014811NICHD NIH HHS P01 HD18655NICHD NIH HHS P30 HD018655
6 · The paper itself

Abstract

In preterm infants, low levels of insulin like growth factor 1 (IGF-I) have been associated with impaired growth and retinopathy of prematurity. Our objective was to study safety and pharmacokinetics of i.v. administered rhIGF-I with its binding protein 3 (rhIGFBP-3) to preterm infants. At 3 d chronological age, an i.v. 3 h infusion of rhIGF-I/rhIGFBP-3 was administered followed by serial measurements of IGF-I and IGFBP-3. Infants were evaluated for physiologic safety measurements. The individual dose of rhIGF-I ranged from 1 to 12 microg/kg. The study was conducted at Queen Silvia Children's Hospital, Gothenburg, Sweden, between January and November 2007. Five patients (3 F) with mean (range) post menstrual age 27 wk (26-29) and birth weight 1022 g (810-1310) participated. IGF-I and IGFBP-3 levels before infusion were median (range) 18 (12-28) and 771 (651-1047) ng/mL, respectively. Immediately after study drug infusion, serum IGF-I and IGFBP-3 levels were 38 (25-59) and 838 (754-1182) ng/mL, respectively. Median (range) half-life for IGF-I and IGFBP-3 was 0.79 (0.59-1.42) and 0.87 (0.85-0.94) hours, respectively. Blood glucose, insulin, sodium, potassium, and physiologic safety measures were within normal ranges. The rhIGF-I/rhIGFBP-3 equimolar proportion was effective in increasing serum IGF-I levels and administration under these study conditions was safe and well tolerated.

Indexed as

Infant, PrematureBirth WeightFemaleGestational AgeHalf-LifeHumansInfant, NewbornInfusions, IntravenousInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor Binding ProteinsInsulin-Like Growth Factor IMaleRecombinant ProteinsIGFBP3 protein, humanInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor Binding ProteinsInsulin-Like Growth Factor IRecombinant Proteins

Identifiers

PMID19190540
PMCPMC4486044
OpenAlexW2123328228

What OpenQuestion holds

Textmetadata
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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.