Evidence map›Paper›PMID 25064164›Full record

Trial reportThe Journal of pediatrics2014

Antenatal pharmacokinetics and placental transfer of N-acetylcysteine in chorioamnionitis for fetal neuroprotection.

Donald B Wiest, Eugene Chang, Deanna Fanning, Sandra Garner, Toby Cox, Dorothea D Jenkins

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
3.0field-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 mapstarted 2015, after this paper: background citation

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
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
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  16. Loss ofFrontiers in neuroscience · 2023
    Article
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  20. Antioxidants (Basel, Switzerland) · 2021
    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

6 authors at 1 institution in 1 country.

Donald B WiestDepartment of Clinical Pharmacy & Outcome Sciences, Medical University of South Carolina, Charleston, SC. Electronic address: wiestdb@musc.edu.
Eugene ChangDepartment of Obstetrics & Gynecology, Medical University of South Carolina, Charleston, SC.
Deanna FanningDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Sandra GarnerDepartment of Clinical Pharmacy & Outcome Sciences, Medical University of South Carolina, Charleston, SC.
Toby CoxDepartment of Clinical Pharmacy & Outcome Sciences, Medical University of South Carolina, Charleston, SC.
Dorothea D JenkinsDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Medical University 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 R01 NS052448PHS HHS R01NSO52448
6 · The paper itself

Abstract

objectiveTo determine the pharmacokinetics (PK) and placental transfer of intravenous (i.v.) N-acetylcysteine (NAC) in mothers with a clinical diagnosis of chorioamnionitis (CA) and determine the PK of i.v. NAC in their infants. STUDY

designIn this prospective, double-blind study i.v. NAC 100 mg/kg/dose or saline was administered within 4 hours of CA diagnosis to pregnant women ≥24 weeks' gestation and then every 6 hours until delivery. Maternal PK and placental transfer were determined with maternal blood and matched maternal and cord venous blood. Neonatal PK estimates were determined from i.v. NAC (12.5-25 mg/kg/dose) administered every 12 hours for 5 doses. Noncompartmental analyses were performed for maternal and neonatal PK estimates.

resultsEleven mothers (5 preterm, 6 near-term) and 12 infants (1 set of twins) received NAC. Maternal clearance (CL) of NAC was faster than in nonpregnant adults, with a terminal elimination half-life of 1.2 ± 0.2 hours. The NAC cord to maternal ratio was 1.4 ± 0.8, suggesting rapid placental transfer and slower rate of fetal CL. Neonatal PK estimates for near-term compared with preterm infants showed a significantly shorter terminal elimination half-life (5.1 vs 7.5 hours, respectively) and greater CL (53.7 vs 45.0 mL/h/kg, respectively).

conclusionsMaternal CL and placental transfer of NAC was rapid, with umbilical cord concentrations frequently exceeding maternal concentrations. The administration of NAC to mothers with CA achieves predictable NAC plasma concentrations in the fetus, indicating that antenatal neuroprotection may be possible for these newborns at high risk for neuroinflammation.

Indexed as

AcetylcysteineChorioamnionitisDouble-Blind MethodFemaleFetal BloodFree Radical ScavengersHumansInflammationInfusions, IntravenousMaleMaternal-Fetal ExchangeMothersNeuroprotective AgentsPilot ProjectsPlacentaPregnancyAcetylcysteineFree Radical ScavengersNeuroprotective Agents

Identifiers

PMID25064164
PMCPMC4177316
OpenAlexW2063209437

What OpenQuestion holds

Textmetadata
LicenceTDM
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.