Evidence map›Paper›PMID 26545726›Full record

Trial reportThe Journal of pediatrics2016

Fetal and Neonatal Effects of N-Acetylcysteine When Used for Neuroprotection in Maternal Chorioamnionitis.

Dorothea D Jenkins, Donald B Wiest, Denise M Mulvihill, Anthony M Hlavacek, Sarah J Majstoravich, Truman R Brown, Joseph J Taylor, Jason R Buckley, Robert P Turner, Laura Grace Rollins and 6 more

4 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT00724594 phase1 / phase2completednot on this map

Safety of N-acetylcysteine in Maternal Chorioamnionitis

TypeinterventionalSponsorMedical University of South CarolinaRan2008 to 2014Enrolled46ConditionsChorioamnionitis, Brain InjuryArmsN-acetylcysteine, Control
NCT03499249 phase2completednot on this mapstarted 2018, after this paper: background citation

A Phase 2 Trial of N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy

TypeinterventionalSponsorBaylor College of MedicineRan2018 to 2024Enrolled13ConditionsBiliary AtresiaArmsN-Acetyl cysteine
NCT04643821 early_phase1completednot on this map

N-Acetylcysteine and Vitamin D in Infants With Hypoxic Ischemic Encephalopathy Treated With Hypothermia

TypeinterventionalSponsorMedical University of South CarolinaRan2015 to 2020Enrolled30ConditionsHIE - Perinatal Hypoxic - Ischemic EncephalopathyArmsN-acetylcysteine, NAC, and calcitriol
NCT06260566 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase 1 Trial of Tolerability of Enteral N-Acetylcysteine in Infants

TypeinterventionalSponsorSanjiv HarpavatRan2026 to 2031Enrolled12ConditionsBiliary AtresiaArmsN-Acetylcysteine
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

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  10. Fetal Cerebral Blood Flow (Dys)autoregulation.Diagnostics (Basel, Switzerland) · 2025
    Review
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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

16 authors at 3 institutions in 1 country.

Dorothea D JenkinsDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC. Electronic address: jenkd@musc.edu.
Donald B WiestDepartment of Clinical Pharmacy and Outcome Science, Medical University of South Carolina, Charleston, SC.
Denise M MulvihillDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Anthony M HlavacekDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Sarah J MajstoravichDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Truman R BrownDepartment of Neuroscience's Center for Advanced Imaging Research, Medical University of South Carolina, Charleston, SC.
Joseph J TaylorDepartment of Neuroscience's Center for Advanced Imaging Research, Medical University of South Carolina, Charleston, SC; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.
Jason R BuckleyDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Robert P TurnerDepartment of Clinical Pediatrics and Neurology, University of South Carolina School of Medicine and Palmetto Health Richland Children's Hospital, Columbia, SC.
Laura Grace RollinsDepartment of Clinical Psychology, University of Massachusetts, Boston, MA.
Jessica P BentzleyDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Kathryn E HopeDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Andrew B BarbourDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Danielle W LoweDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Renee H MartinDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Eugene Y ChangDepartment of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC.
Medical University of South Carolina · USUniversity of Massachusetts Boston · USUniversity of South Carolina · US

Funding

Safety of N-acetylcysteine in Maternal ChorioamnionitisR01NS052448 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI JENKINS, DOROTHEA DENISE · 2007 to 2009
$1.5M
NINDS NIH HHS NS52448NINDS NIH HHS R01 NS052448
6 · The paper itself

Abstract

objectiveTo evaluate the clinical safety of antenatal and postnatal N-acetylcysteine (NAC) as a neuroprotective agent in maternal chorioamnionitis in a randomized, controlled, double-blinded trial. STUDY

designTwenty-two mothers >24 weeks gestation presenting within 4 hours of diagnosis of clinical chorioamnionitis were randomized with their 24 infants to NAC or saline treatment. Antenatal NAC (100 mg/kg/dose) or saline was given intravenously every 6 hours until delivery. Postnatally, NAC (12.5-25 mg/kg/dose, n = 12) or saline (n = 12) was given every 12 hours for 5 doses. Doppler studies of fetal umbilical and fetal and infant cerebral blood flow, cranial ultrasounds, echocardiograms, cerebral oxygenation, electroencephalograms, and serum cytokines were evaluated before and after treatment, and 12, 24, and 48 hours after birth. Magnetic resonance spectroscopy and diffusion imaging were performed at term age equivalent. Development was followed for cerebral palsy or autism to 4 years of age.

resultsCardiovascular measures, cerebral blood flow velocity and vascular resistance, and cerebral oxygenation did not differ between treatment groups. Cerebrovascular coupling was disrupted in infants with chorioamnionitis treated with saline but preserved in infants treated with NAC, suggesting improved vascular regulation in the presence of neuroinflammation. Infants treated with NAC had higher serum anti-inflammatory interleukin-1 receptor antagonist and lower proinflammatory vascular endothelial growth factor over time vs controls. No adverse events related to NAC administration were noted.

conclusionsIn this cohort of newborns exposed to chorioamnionitis, antenatal and postnatal NAC was safe, preserved cerebrovascular regulation, and increased an anti-inflammatory neuroprotective protein.

trial registrationClinicalTrials.gov: NCT00724594.

Indexed as

AcetylcysteineCerebrovascular CirculationChorioamnionitisDouble-Blind MethodEchoencephalographyElectroencephalographyFemaleFetusHumansInfantInfant, NewbornMagnetic Resonance ImagingMaleMothersNeuroprotective AgentsPregnancyAcetylcysteineNeuroprotective Agents

Identifiers

PMID26545726
PMCPMC4698030
OpenAlexW1956521517

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.