Evidence map›Paper›PMID 31101409›Full record

ArticleThe Journal of pediatrics2019

Dosing and Safety of Off-label Use of Caffeine Citrate in Premature Infants.

Mihai Puia-Dumitrescu, P Brian Smith, Jian Zhao, Angela Soriano, Elizabeth H Payne, Barrie Harper, Ellen Bendel-Stenzel, Fernando Moya, Rakesh Chhabra, Lawrence Ku and 3 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 11% 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

8 citing papers in PubMed, 28 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Immature control of breathing and apnea of prematurity: the known and unknown.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Review
  7. Article
  8. Evaluation of the Use of Caffeine Citrate Maintenance Doses >5 mg/kg/day in Preterm Neonates for Apnea of Prematurity.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    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

13 authors at 9 institutions in 1 country.

Mihai Puia-DumitrescuDepartment of Pediatrics, University of Washington, Seattle, WA; Department of Pediatrics, Duke University Medical Center, Durham, NC.
P Brian SmithDepartment of Pediatrics, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Jian ZhaoEMMES Corporation, Rockville, MD.
Angela SorianoEMMES Corporation, Rockville, MD.
Elizabeth H PayneEMMES Corporation, Rockville, MD.
Barrie HarperDuke Clinical Research Institute, Durham, NC.
Ellen Bendel-StenzelChildren's Hospitals and Clinics of Minnesota, Minneapolis, MN.
Fernando MoyaNew Hanover Regional Medical Center, Coastal Carolina Neonatology, Wilmington, NC.
Rakesh ChhabraHackensack University Medical Center, Hackensack, NJ.
Lawrence KuDepartment of Pediatrics, Duke University Medical Center, Durham, NC.
Matthew LaughonDuke Clinical Research Institute, Durham, NC; Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
Kelly C WadeDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA. Electronic address: Kelly.Wade@uphs.upenn.edu.
Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee
Emmes (United States) · USClinical Research Institute · USChildren's Hospital of Philadelphia · USChildren's Minnesota · USDuke Medical Center · USHackensack University Medical Center · USNew Hanover Regional Medical Center · USUniversity of North Carolina at Chapel Hill · USUniversity of Washington · US

Funding

Project-005U2COD023375 · OD · DUKE UNIVERSITY · PI Linda S Adair, Phillip Brian Smith · 2016 to 2026
$215.9M
Duke Research Training Program for PediatriciansT32HD043029 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2002 to 2017
$3.7M
North Carolina Clinical CenterUG1HD040492 · NICHD · DUKE UNIVERSITY · PI CHARLES Michael COTTEN, Matthew Laughon · 2016 to 2026
$3.4M
Safety of furosemide in premature infants at risk of bronchopulmonary dysplasiaR01FD005101 · FDA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2016 to 2018
$1.1M
Echocardiogram to Diagnose Pulmonary Hypertension in Premature InfantsR34HL124038 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2015 to 2016
$719k
Mentorship of Early-Career Clinicians in Bronchopulmonary Dysplasia Drug TherapiesK24HL143283 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2019 to 2023
$613k
FDA HHS R01 FD005101Intramural NIH HHS Z99 HD999999NHLBI NIH HHS K24 HL143283NHLBI NIH HHS R34 HL124038NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS HHSN275201800003INICHD NIH HHS T32 HD043029NICHD NIH HHS UG1 HD040492NIH HHS U2C OD023375
6 · The paper itself

Abstract

objectiveTo characterize the dosing and safety of off-label caffeine citrate in a contemporary cohort of extremely premature infants. STUDY

designWe used electronic health records (2010-2013) from 4 neonatal intensive care units to identify infants of ≤28 weeks of gestational age exposed to caffeine citrate. Safety outcomes included death, bronchopulmonary dysplasia, necrotizing enterocolitis, spontaneous intestinal perforation, intraventricular hemorrhage, patent ductus arteriosus ligation, seizures, and arrhythmias. We used multivariable logistic regression to evaluate the association of caffeine citrate exposure with clinical events.

resultsOf 410 infants with a median (IQR) gestational age of 26 (24-27) weeks, 95% received caffeine citrate for >0 days. Infants received a median (IQR) daily dose of 8 (5-10) mg/kg/day. Incidences of clinical events on day of caffeine citrate exposure were death 2%, patent ductus arteriosus ligation 12%, and medical and surgical necrotizing enterocolitis 5% and 4%, respectively. Bronchopulmonary dysplasia occurred in 37% of infants and was not associated with caffeine dose. Increased caffeine citrate dose was associated with lower odds of patent ductus arteriosus ligation and necrotizing enterocolitis.

conclusionsCaffeine citrate was used in extremely premature infants at younger gestation, at higher doses, and for longer durations than recommended on the drug label. Increased caffeine citrate exposure, dose, or therapy duration was not associated with increased risk of necrotizing enterocolitis.

Indexed as

Off-Label UseApneaBronchopulmonary DysplasiaCaffeineCerebral HemorrhageCitratesDuctus Arteriosus, PatentElectronic Health RecordsEnterocolitis, NecrotizingFemaleGestational AgeHumansInfant, Extremely PrematureInfant, Low Birth WeightInfant, NewbornInfant, PrematureCaffeinecaffeine citrateCitratesapneabronchopulmonary dysplasianecrotizing enterocolitis

Identifiers

PMID31101409
PMCPMC6661003
OpenAlexW2945465453

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.