Evidence map›Paper›PMID 36344872›Full record

ArticleWorld journal of pediatrics : WJP2023

Assessment of compatibility of rhIGF-1/rhIGFBP-3 with neonatal intravenous medications.

Nazila Salamat-Miller, Mark A Turner, Amey Bandekar, Nitin Dixit, Emily Jochim, Barry Mangum, Christopher McPherson, Srini Tenjarla, Sukhjeet Singh, You Seok Hwang and 1 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in World journal of pediatrics : WJP, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 47% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

11 authors at 3 institutions in 2 countries.

Nazila Salamat-MillerTakeda, 200 Shire Way, Lexington, MA, 02421, USA. nazila.miller@takeda.com.ORCID 0000-0001-5055-531X
Mark A TurnerInstitute of Translational Medicine, University of Liverpool, Liverpool, UK.
Amey Bandekar *Takeda, 200 Shire Way, Lexington, MA, 02421, USA.
Nitin DixitTakeda, 200 Shire Way, Lexington, MA, 02421, USA.
Emily Jochim *Takeda, 200 Shire Way, Lexington, MA, 02421, USA.
Barry MangumPaidion Research, Durham, NC, USA.
Christopher McPhersonWashington University, St. Louis, MO, USA.
Srini TenjarlaTakeda, 200 Shire Way, Lexington, MA, 02421, USA.
Sukhjeet Singh *Takeda, 200 Shire Way, Lexington, MA, 02421, USA.
You Seok Hwang *Takeda, 200 Shire Way, Lexington, MA, 02421, USA.
Norman Barton *Takeda, 200 Shire Way, Lexington, MA, 02421, USA.
Takeda (United States) · USUniversity of Liverpool · GBWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecombinant human (rh)IGF-1/IGFBP-3 protein complex, administered as a continuous intravenous infusion in preterm infants, is being studied for the prevention of complications of prematurity.

methodsWe conducted in vitro studies to evaluate the physical and chemical compatibility of rhIGF-1/IGFBP-3 with medications routinely administered to preterm neonates. In vitro mixing of rhIGF-1/IGFBP-3 drug product with small-molecule test medications plus corresponding controls was performed. Physical compatibility was defined as no color change, precipitation, turbidity, gas evolution, no clinically relevant change in pH/osmolality or loss in medication content. Chemical compatibility of small molecules was assessed using liquid chromatography (e.g., reverse-phase HPLC and ion chromatography), with incompatibility defined as loss of concentration of ≥ 10%. A risk evaluation was conducted for each medication based on in vitro compatibility data and potential for chemical modification.

resultsIn vitro physical compatibility was established for 11/19 medications: caffeine citrate, fentanyl, fluconazole, gentamicin, insulin, intravenous fat emulsion, midazolam, morphine sulfate, custom-mixed parenteral nutrition solution (with/without electrolytes), parenteral nutrition solution + intravenous fat emulsion, and vancomycin (dosed from a 5 mg/mL solution), but not for 8/19 medications: amikacin, ampicillin, dopamine, dobutamine, furosemide, meropenem, norepinephrine, and penicillin G, largely owing to changes in pH after mixing. Small-molecule compatibility was unaffected post-mixing, with no loss of small-molecule content. For physically compatible medications, risk analyses confirmed low probability and severity of a risk event.

conclusionCo-administration of rhIGF-1/rhIGFBP-3 drug product with various medications was assessed by in vitro studies using case-by-case risk analyses to determine the suitability of the products for co-administration.

Indexed as

Insulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IFat Emulsions, IntravenousHumansInfantInfant, NewbornInfant, PrematureInfusions, IntravenousRecombinant ProteinsFat Emulsions, IntravenousInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IRecombinant ProteinsChemical compatibilityIntravenousNeonatalPhysical compatibilityrhIGF-1/rhIGFBP-3

Identifiers

PMID36344872
PMCPMC9832074
OpenAlexW4308426632

What OpenQuestion holds

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LicenceCC BY
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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.