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Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)

NCT00724594 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-04-12

Study results available
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Summary

The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease brain injury in babies exposed to intrauterine infection without causing significant side effects.

Conditions

  • Chorioamnionitis
  • Brain Injury

Interventions

DRUG

N-acetylcysteine

NAC (100 mg/kg/dose) was given intravenously to mothers within 4 hours of diagnosis of chorioamnionitis, and every 6 hours until delivery. NAC was given to preterm (12.5 mg/kg/dose) and term infants (25 mg/kg/dose) every 12 hours for 5 doses after birth.

DRUG

Control

Saline was given in the same volume, at the same timing as NAC infusions

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Dorothea D. Jenkins, MD · Medical University of South Carolina

  • Eugene Chang, MD · Medical University of South Carolina (Obstetric Principal Investigator)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724594 on ClinicalTrials.gov