Evidence map›Paper›PMID 42401326›Full record

Trial reportThe Journal of pediatrics2026

Parenteral Lipid Dose and Bilirubin Neurotoxicity in Extremely Preterm Infants: A Factorial Randomized Trial.

Lindsay F Holzapfel, Jon E Tyson, Steven M Shapiro, Claudia Pedroza, Eric Reynolds, Kyung Hyun Lee, Matthew A Rysavy, Alan Kleinfeld, Andrew H Huber, Mar Romero Lopez and 2 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04584983 (Bilirubin Neurotoxicity), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04584983 phase2active not recruitingnot on this map

Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan2021 to 2026Enrolled134ConditionsBilirubin EncephalopathyArmsusual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Lindsay F HolzapfelDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Division of Perinatal Neonatal Medicine, Department of Pediatrics, Children's Memorial Hermann Hospital, Houston, TX. Electronic address: Lindsay.n.fleig@uth.tmc.edu.
Jon E TysonDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Institute for Clinical Research and Learning Healthcare, McGovern Medical School at the University of Texas Science Center at Houston, Houston, TX.
Steven M ShapiroDepartment of Neurology, University of Kansas Medical Center, Kansas City, KS.
Claudia PedrozaDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Institute for Clinical Research and Learning Healthcare, McGovern Medical School at the University of Texas Science Center at Houston, Houston, TX.
Eric ReynoldsDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Division of Perinatal Neonatal Medicine, Department of Pediatrics, Children's Memorial Hermann Hospital, Houston, TX.
Kyung Hyun LeeDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Institute for Clinical Research and Learning Healthcare, McGovern Medical School at the University of Texas Science Center at Houston, Houston, TX.
Matthew A RysavyDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Division of Perinatal Neonatal Medicine, Department of Pediatrics, Children's Memorial Hermann Hospital, Houston, TX; Institute for Clinical Research and Learning Healthcare, McGovern Medical School at the University of Texas Science Center at Houston, Houston, TX.
Alan KleinfeldFluoresprobe Sciences, San Diego, CA.
Andrew H HuberFluoresprobe Sciences, San Diego, CA.
Mar Romero LopezDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Division of Perinatal Neonatal Medicine, Department of Pediatrics, Children's Memorial Hermann Hospital, Houston, TX; Institute for Clinical Research and Learning Healthcare, McGovern Medical School at the University of Texas Science Center at Houston, Houston, TX.
Amir M KhanDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Division of Perinatal Neonatal Medicine, Department of Pediatrics, Children's Memorial Hermann Hospital, Houston, TX.
Cody ArnoldDepartment of Pediatrics, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX; Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University, Palo Alto, CA.

Funding

Institutional Career Development CoreKL2TR003168 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MILLER, CHARLES C · 2019 to 2023
$4.9M
NCATS NIH HHS KL2 TR003168NICHD NIH HHS L40 HD109887
6 · The paper itself

Abstract

objectiveTo assess whether a lower maximum dose of soybean oil lipid emulsion reduces bilirubin neurotoxicity measured by brainstem auditory evoked response wave V latency. STUDY

designSingle-center Bayesian randomized trial (January 2021-January 2024) in a level IV neonatal intensive care unit. Infants born at <27 weeks or ≤750 g were stratified by phototherapy regimen, randomized to 1.5 vs 3.0 g/kg/day maximum soybean oil lipid emulsion (Intralipid) doses through day 14.

resultsOf 143 eligible infants, 134 were enrolled (67 lower dose, 65 higher dose). Mean [SD] daily lipid administration was 1.1 [0.3] vs 1.96 [0.58] g/kg/day. Unbound bilirubin levels were similar between groups although values ≥ 30 and ≥ 40 nM occurred more often in the higher dose group (14.5% vs 28.6% and 6.5% vs 16.1%), even at low total serum bilirubin levels (3-8 mg/dL). Adjusted wave V latency did not differ between groups (7.36 ms [0.53] vs 7.22 ms [0.57], aMD: -0.14 [95% CrI -0.34, 0.06]), with no interaction with phototherapy dose. Clinical outcomes and growth were comparable.

conclusionsThe lower maximum lipid dose did not reduce brainstem auditory evoked response wave V latency. Elevated unbound bilirubin levels occurred at the higher dose, suggesting the need for a multicenter safety trial in extremely preterm infants.

trial registrationClinicalTrials.gov https://clinicaltrials.gov/study/NCT04584983.

Indexed as

BilirubinFat Emulsions, IntravenousSoybean OilBayes TheoremDose-Response Relationship, DrugEvoked Potentials, Auditory, Brain StemFemaleHumansInfant, Extremely PrematureInfant, NewbornIntensive Care Units, NeonatalMaleBilirubinFat Emulsions, IntravenousSoybean Oilbilirubin neurotoxicitybrainstem auditory evoke responseclinical trialextremely preterm infantintravenous lipid emulsionsneonatal nutritionneurodevelopmental impairmentunbound bilirubinwave V latency

Identifiers

PMID42401326
PMCPMC13428500

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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.