CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
N-acetylcysteine +1 moredrug
Likely dose
N-acetylcysteine 100 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00724594
NCT00724594Phase 2Completed
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Safety of N-acetylcysteine in Maternal Chorioamnionitis

Medical University of South Carolina·interventional·Posted Jul 29, 2008·Updated Apr 12, 2021

In Brief

A Phase 2 clinical trial evaluating N-acetylcysteine and Control for Chorioamnionitis and Brain Injury. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChorioamnionitis, Brain Injury
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 17.9 years ago

Interventions

N-acetylcysteinedrug

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.

Controldrug

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