Evidence map›Paper›PMID 27870826›Full record

Trial reportPediatric research2017

Development and verification of a pharmacokinetic model to optimize physiologic replacement of rhIGF-1/rhIGFBP-3 in preterm infants.

Jou-Ku Chung, Boubou Hallberg, Ingrid Hansen-Pupp, Martin A Graham, Gerald Fetterly, Jyoti Sharma, Adina Tocoian, Nerissa C Kreher, Norman Barton, Ann Hellström and 1 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

15 citing papers in PubMed, 18 citations in OpenAlex.

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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 4 institutions in 2 countries.

Jou-Ku ChungShire, Lexington, Massachusetts.
Boubou HallbergDepartment of Neonatology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Ingrid Hansen-PuppDepartment of Clinical Sciences Lund, Pediatrics, Skåne University Hospital, Lund University, Lund, Sweden.
Martin A GrahamKinderPharm/PKPD Bioscience Inc., Exton, Pennsylvania.
Gerald FetterlyKinderPharm/PKPD Bioscience Inc., Exton, Pennsylvania.
Jyoti SharmaKinderPharm/PKPD Bioscience Inc., Exton, Pennsylvania.
Adina TocoianShire, Zug, Switzerland.
Nerissa C KreherShire, Lexington, Massachusetts.
Norman BartonShire, Lexington, Massachusetts.
Ann HellströmInstitute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
David LeyDepartment of Clinical Sciences Lund, Pediatrics, Skåne University Hospital, Lund University, Lund, Sweden.
Takeda (United States) · USSkåne University Hospital · SEKarolinska Institutet · SEUniversity of Gothenburg · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundrhIGF-1/rhIGFBP-3 is being investigated for prevention of retinopathy of prematurity in extremely preterm infants.

methodsA population pharmacokinetic model was developed using data from phase I/II (Sections A-C) trials of rhIGF-1/rhIGFBP-3 and additional studies in preterm infants to predict optimal dosing to establish/maintain serum IGF-1 within physiological intrauterine levels. In Section D of the phase II study, infants (gestational age (GA) (wk+d) 23+0 to 27+6) were randomized to rhIGF-1/rhIGFBP-3, administered at the model-predicted dose of 250 µg/kg/d continuous i.v. infusion up to postmenstrual age (PMA) 29 wk+6 d or standard of care. An interim pharmacokinetic analysis was performed for the first 10 treated infants to verify dosing.

resultsSerum IGF-1 data were reviewed for 10 treated/9 control infants. Duration of therapy in treated infants ranged 1-34.5 d. At baseline (before infusion and <24 h from birth), mean (SD) IGF-1 was 19.2 (8.0) μg/l (treated) and 15.4 (4.7) μg/l (controls). Mean (SD) IGF-1 increased to 45.9 (19.6) μg/l at 12 h in treated infants, and remained within target levels for all subsequent timepoints. For treated infants, 88.8% of the IGF-1 measurements were within target levels (controls, 11.1%).

conclusionThrough the reported work, we determined appropriate rhIGF-1/rhIGFBP-3 dosing to achieve physiological intrauterine serum IGF-1 levels in extremely preterm infants.

Indexed as

Blood GlucoseComputer SimulationFemaleGestational AgeHumansInfant, Extremely PrematureInfant, NewbornInfant, PrematureInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IMaleRecombinant ProteinsReference ValuesTime FactorsBlood GlucoseInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IRecombinant Proteins

Identifiers

PMID27870826
OpenAlexW2556073487

What OpenQuestion holds

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Registered trials

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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.