Evidence map›Paper›PMID 27390109›Full record

ArticleEarly human development2016

Safety of histamine-2 receptor blockers in hospitalized VLBW infants.

Andrew Romaine, Daniel Ye, Zachary Ao, Francia Fang, Octavious Johnson, Taylor Blake, Daniel K Benjamin, C Michael Cotten, Daniela Testoni, Reese H Clark and 4 more

Abstract readMulticenter Study
In one paragraph

Article in Early human development, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 5% 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, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Cost-effectiveness of probiotics for necrotizing enterocolitis prevention in very low birth weight infants.Journal of perinatology : official journal of the California Perinatal Association · 2020
    Article
  4. Neonatal intestinal dysbiosis in necrotizing enterocolitis.Molecular medicine (Cambridge, Mass.) · 2018
    Review
  5. Article
  6. Review
  7. Article
  8. 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

14 authors at 1 institution in 1 country.

Andrew RomaineDuke Clinical Research Institute, Durham, NC, USA. Electronic address: aromaine@live.unc.edu.
Daniel YeDuke Clinical Research Institute, Durham, NC, USA. Electronic address: daniel.ye@duke.edu.
Zachary AoDuke Clinical Research Institute, Durham, NC, USA. Electronic address: aosterrr@gmail.com.
Francia FangDuke Clinical Research Institute, Durham, NC, USA. Electronic address: francia.fang@duke.edu.
Octavious JohnsonDuke Clinical Research Institute, Durham, NC, USA. Electronic address: octaviousjohnson33@yahoo.com.
Taylor BlakeDuke Clinical Research Institute, Durham, NC, USA. Electronic address: tsblake015@gmail.com.
Daniel K BenjaminDuke Clinical Research Institute, Durham, NC, USA. Electronic address: danny.benjamin@dm.duke.edu.
C Michael CottenDuke Clinical Research Institute, Durham, NC, USA. Electronic address: michael.cotten@duke.edu.
Daniela TestoniDuke Clinical Research Institute, Durham, NC, USA. Electronic address: danielatestoni@gmail.com.
Reese H ClarkPediatrix-Obstetrix Center for Research and Education, Sunrise, FL,USA. Electronic address: Reese_H_Clark@us.MEDNAX.com.
Vivian H ChuDuke Clinical Research Institute, Durham, NC, USA. Electronic address: vivian.chu@duke.edu.
P Brian SmithDuke Clinical Research Institute, Durham, NC, USA. Electronic address: brian.smith@dm.duke.edu.
Christoph P HornikDuke Clinical Research Institute, Durham, NC, USA. Electronic address: christoph.hornik@dm.duke.edu.
Best Pharmaceuticals for Children Act – Pediatric Trials Network
Clinical Research Institute · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemiaR01HD081044 · NICHD · DUKE UNIVERSITY · PI FISHER, BRIAN T, STEINBACH, WILLIAM J · 2014 to 2018
$3.2M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
NIH Summer Research Experience Programs (R25)R25HD076475 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2013 to 2023
$1.1M
PATIENT SAFETY RESEARCH DURING NEONATAL CARE (R21)R21HD080606 · NICHD · DUKE UNIVERSITY · PI SMITH, PHILLIP BRIAN · 2015 to 2016
$457k
FDA HHS R18 FD005292NCATS NIH HHS UL1 TR001117NIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD081044NICHD NIH HHS R21 HD080606NICHD NIH HHS R25 HD076475
6 · The paper itself

Abstract

backgroundHistamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data.

aimsWe sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in hospitalized very low birth weight (VLBW) infants. STUDY

designWe conducted a retrospective cohort study using a clinical database populated by an electronic health record shared by 348 neonatal intensive care units in the United States. SUBJECTS: We included all VLBW infants without major congenital anomalies. OUTCOME MEASURES: We used multivariable logistic regression with generalizing estimating equations to evaluate the association between days of H2 blocker exposure and risk of: 1) death or necrotizing enterocolitis (NEC); 2) death or sepsis; and 3) death, NEC, or sepsis.

resultsOf 127,707 infants, 20,288 (16%) were exposed to H2 blockers for a total of 6,422,352days. Median gestational age for infants exposed to H2 blockers was 27weeks (25th 75th percentile 26, 29). H2 blocker use decreased from 18% of infants in 1997 to 8% in 2012 (p<0.001). On multivariable analysis, infants were at increased risk of the combined outcome of death, NEC, or sepsis on days exposed to H2 blockers (odds ratio=1.14) (95% confidence interval 1.08, 1.19).

conclusionsH2 blocker use is associated with increased risk of the combined outcome of death, NEC, or sepsis in hospitalized VLBW infants.

Indexed as

Infant MortalityInfant, Very Low Birth WeightEnterocolitis, NecrotizingFemaleHistamine H2 AntagonistsHumansInfantInfant, NewbornIntensive Care Units, NeonatalMaleRetrospective StudiesSepsisHistamine H2 AntagonistsH2 blockersHistamine-2 receptor antagonistsInfantsNecrotizing enterocolitis

Identifiers

PMID27390109
PMCPMC4969147
OpenAlexW2464003619

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.