Status:
COMPLETED
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Chorioamnionitis
Brain Injury
Eligibility:
All Genders
13+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Chorioamnionitits is an infection in the fluid and membranes surrounding the baby in utero. Intrauterine infection is associated with significant white and grey matter brain injury in newborns and is ...
Eligibility Criteria
Inclusion
- Participants had all of the following to qualify:
- Chorioamnionitis, defined as either 1) clinical diagnosis of choriomanionitis 2) maternal fever greater than or equal to 100 degrees F in the presence of rupture of membranes or 2 of the following: uterine tenderness, maternal WBC \> 15,000 cells/mm, fetal tachycardia \> 160 bpm, malodorous amniotic fluid, or in preterm group only, rupture of membranes and active preterm labor.
- Gestational age ≥ 24 completed weeks, by first trimester ultrasound or date of last menstrual period.
- No greater than 4 hours from onset of fever or diagnosis.
Exclusion
- Participants had none of the following:
- Asthma, steroid-dependent
- Clinical sepsis, whether viral or bacterial in nature, defined as fever with signs of cardiovascular compromise in mother (blood pressure \< 90/50, heart rate \> 120 bpm, need for oxygen due to maternal saturations below 92%, pneumonia, pyelonephritis, or meningitis)
- Seizure disorder
- Fetal weight or biparietal diameter less than the 10th% for gestational age
- Suspected major genetic or congenital abnormality
- Fetal distress which demands immediate delivery (poor fetal biophysical profile, late decelerations, sinusoidal fetal heart rate pattern)
- Participation in another therapeutic clinical trial
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00724594
Start Date
August 1 2008
End Date
August 1 2014
Last Update
April 12 2021
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425