Evidence map›Paper›PMID 28969546›Full record

ReviewCurrent pharmaceutical design2017

IGF-1 as a Drug for Preterm Infants: A Step-Wise Clinical Development.

Ann Hellstrom, David Ley, Boubou Hallberg, Chatarina Lofqvist, Ingrid Hansen-Pupp, Luca A Ramenghi, Jan Borg, Lois E H Smith, Anna-Lena Hard

Open access · bronzeAbstract readReview
In one paragraph

Review in Current pharmaceutical design, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
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 3 countries.

Ann HellstromDepartment of Ophthalmology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
David LeyDepartment of Pediatrics, Institute of Clinical Sciences Lund, Lund University and Skane University Hospital, Lund, Sweden.
Boubou HallbergDepartment of Neonatology, Karolinska Institute and University Hospital, Stockholm, Sweden.
Chatarina LofqvistDepartment of Ophthalmology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Ingrid Hansen-PuppDepartment of Pediatrics, Institute of Clinical Sciences Lund, Lund University and Skane University Hospital, Lund, Sweden.
Luca A RamenghiGenova Neonatal Intensive Care Unit, Instituto Pediatrico Giannina Gaslini, Genova, Italy.
Jan BorgFormer Premacure AB, Uppsala, Sweden.
Lois E H SmithDepartment of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston, MA, United States.
Anna-Lena HardDepartment of Ophthalmology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
University of Gothenburg · SELund University · SEBoston Children's Hospital · USIstituto Giannina Gaslini · ITKarolinska University Hospital · SE

Funding

Dietary control of angiogenesis in retinopathy modelsR01EY017017 · NEI · BOSTON CHILDREN'S HOSPITAL · PI Zhongjie Fu, Lois Smith · 2006 to 2026
$11.8M
NEI NIH HHS R01 EY017017
6 · The paper itself

Abstract

backgroundInsulin-like growth factor 1 (IGF-1) is a mitogenic hormone involved in many processes such as growth, metabolism, angiogenesis and differentiation. After very preterm birth, energy demands increase while maternal supplies of nutrients and other factors are lost and the infant may become dependent on parenteral nutrition for weeks. Low postnatal IGF-1 concentrations in preterm infants are associated with poor weight gain, retinopathy of prematurity (ROP) and other morbidities. We will describe the process by which we aim to develop supplementation with recombinant human (rh) IGF-1 and its binding protein rhIGFBP-3 as a possible therapy to promote growth and maturation and reduce morbidities in extremely preterm infants.

methodsIn order to calculate a dose of IGF-1 tolerated by neonates, a pharmacokinetic study of transfusion with fresh frozen plasma was performed, which provided a relatively low dose of IGF-1, (on average 1.4 µg/kg), that increased serum IGF-1 to levels close to those observed in fetuses and preterm infants of similar GAs. Thereafter, a Phase I 3 hours IV infusion of rhIGF-1/rhIGFBP-3 was conducted in 5 infants, followed by a Phase II study with four sections (A-D). In the Phase II, sections A-D studies, time on infusion increased and younger gestational ages were included.

resultsIV infusion increased IGF-1 but with short half-life (0.5h) implying a need for continuous infusion. In order to obtain in utero levels of IGF-I, the dose was increased from 100 to 250 µg/kg/24 h and the infusion was prolonged from 3 weeks postnatal age until a postmenstrual age of 29 weeks and 6 days.

conclusionThe purpose has been to ensure high-quality research into the development of a new drug for preterm infants. We hope that our work will help to establish a new standard for the testing of medications for preterm infants.

Indexed as

Drug DevelopmentHumansInfant, NewbornInfusions, IntravenousInsulin-Like Growth Factor IPlasmaIGF1 protein, humanInsulin-Like Growth Factor Idrug developmentIGF-1pharmacokineticPreterm infantpreterm morbidity.

Identifiers

PMID28969546
PMCPMC5824464
OpenAlexW2763648921

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.