Evidence map›Paper›PMID 36007918›Full record

Trial reportAmerican journal of perinatology2024

The Association between Prenatal Nicotine Exposure and Offspring's Hearing Impairment.

Erin M Cleary, Douglas A Kniss, Lida M Fette, Brenna L Hughes, George R Saade, Mara J Dinsmoor, Uma M Reddy, Cynthia Gyamfi-Bannerman, Michael W Varner, William H Goodnight and 11 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in American journal of perinatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

21 authors.

Erin M ClearyDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.ORCID 0000-0003-0574-5020
Douglas A KnissDepartment of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.
Lida M FetteGeorge Washington University Biostatistics Center, Washington, District of Columbia.
Brenna L HughesBrown University, Providence, Rhode Island.
George R SaadeUniversity of Texas Medical Branch, Galveston, Texas.
Mara J DinsmoorNorthwestern University, Chicago, Illinois.ORCID 0000-0002-4643-8871
Uma M Reddythe Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Cynthia Gyamfi-BannermanColumbia University, New York, New York.
Michael W VarnerUniversity of Utah Health Sciences Center, Salt Lake City, Utah.ORCID 0000-0001-9455-3973
William H GoodnightUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Alan T N TitaUniversity of Alabama at Birmingham, Birmingham, Alabama.
Geeta K SwamyDuke University, Durham, North Carolina.
Kent D HeyborneUniversity of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado.
Edward K ChienCase Western Reserve University, Cleveland, Ohio.
Suneet P ChauhanUniversity of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, Texas.
Yasser Y El-SayedStanford University, Stanford, California.
Brian M CaseyUniversity of Texas Southwestern Medical Center, Dallas, Texas.
Samuel ParryUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Hyagriv N SimhanDepartment of Obstetrics, Gynecology and Reproductive SciencesUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Peter G NapolitanoMadigan Army Medical Center, Joint Base Lewis-McChord, Washington, District of Columbia.
Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units (MFMU) Network

Funding

Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research NetU10HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI CLIFTON, REBECCA GERSNOVIEZ · 2009 to 2021
$174.2M
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
SARS-CoV-2 Vaccine Pregnancy RegistryU24HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI Rebecca Gersnoviez Clifton · 2021 to 2026
$39.2M
MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTRU01HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI THOM, ELIZABETH ANN · 1998 to 2008
$27.0M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
NICHD Maternal Fetal Medicine Units NetworkU10HD034116 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI CASEY, BRIAN M · 1996 to 2015
$19.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD034208 · NICHD · UNIVERSITY OF UTAH · PI VARNER, MICHAEL W. · 1996 to 2015
$16.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD027869 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 1991 to 2015
$12.8M
NICHD Maternal Fetal Medicine Units NetworkU10HD040485 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAPNER, RONALD · 2001 to 2015
$12.5M
NICHD Maternal Fetal Medicine Units NetworkU10HD040560 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI THORP, JOHN M · 2001 to 2015
$10.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1 TR001873NICHD NIH HHS U01 HD036801NICHD NIH HHS U10 HD027869NICHD NIH HHS U10 HD027915NICHD NIH HHS U10 HD034116NICHD NIH HHS U10 HD034208NICHD NIH HHS U10 HD036801NICHD NIH HHS U10 HD040485NICHD NIH HHS U10 HD040500NICHD NIH HHS U10 HD040512NICHD NIH HHS U10 HD040544NICHD NIH HHS U10 HD040545NICHD NIH HHS U10 HD040560NICHD NIH HHS U10 HD053097NICHD NIH HHS U10 HD068258NICHD NIH HHS U10 HD068268NICHD NIH HHS U10 HD068282NICHD NIH HHS U24 HD036801NICHD NIH HHS UG1 HD027869NICHD NIH HHS UG1 HD027915NICHD NIH HHS UG1 HD034116NICHD NIH HHS UG1 HD034208NICHD NIH HHS UG1 HD040485NICHD NIH HHS UG1 HD040500NICHD NIH HHS UG1 HD040512NICHD NIH HHS UG1 HD040544NICHD NIH HHS UG1 HD040545NICHD NIH HHS UG1 HD040560NICHD NIH HHS UG1 HD053097NICHD NIH HHS UG1 HD068258NICHD NIH HHS UG1 HD068268NICHD NIH HHS UG1 HD068282NICHD NIH HHS UG1 HD087192NICHD NIH HHS UG1 HD087230
6 · The paper itself

Abstract

objectivesThe objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction. MATERIALS AND

methodsSecondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8 kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine >5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure (

resultsOf 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55-4.20), but the difference was not significantly different (adjusted odds ratio [aOR] = 1.0, 95% CI 0.30-3.31). This association was similar when exposure was stratified as heavy (>100 ng/mL, aOR 0.72, 95% CI 0.15-3.51) or mild (5-100 ng/mL, aOR 1.28, 95% CI 0.33-4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude.

conclusionIn a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs. KEY POINTS: · Nicotine exposure was quantified from maternal urine.. · Nicotine exposure was identified in 30% of the cohort.. · Exposure was not associated with offspring hearing dysfunction..

Indexed as

CotinineCytomegalovirus InfectionsHearing LossNicotinePrenatal Exposure Delayed EffectsAdultFemaleHumansInfant, NewbornLogistic ModelsMaleMultivariate AnalysisOtoacoustic Emissions, SpontaneousPregnancyCotinineNicotine

Identifiers

PMID36007918
PMCPMC9958273

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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.