Charleston, South Carolina 29425


Purpose:

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


Study summary:

Chorioamnionitits is an intrauterine infection—an infection in the fluid and membranes surrounding the baby in utero. The infection, and the baby's response to the infection, can cause inflammation in the baby's brain which affects development. Intrauterine infection is associated with significant white and grey matter brain injury in newborns and is particularly important in the pathogenesis of periventricular leukomalacia (PVL) and cerebral palsy (CP). Brain injury, particularly CP, has been shown to be 4-9 times higher in babies exposed to intrauterine infection than in normal infants. Treating both the mother and baby with antibiotics is part of routine care, however this has not been shown to change the risk for brain injury in the baby. N-acetylcysteine (NAC) is a promising anti-oxidant therapy that has shown effective neuroprotection in an animal model of chorioamnionitis, and has a favorable safety profile with limited and manageable side effects. There are extensive clinical experience and safety data in pregnant mothers and preterm infants, established from acetaminophen overdose and European studies of NAC for prevention of chronic lung disease of prematurity. In this pilot clinical trial, scientists will determine the safety of two different doses of NAC given to pregnant women who present with chorioamnionitis at greater than 24 weeks gestation. In the trial, intravenous NAC will be given to mothers antenatally (and to their infants postnatally) who present with the diagnosis of chorioamnionitis, to evaluate safety and pharmacokinetics (PK) in mothers and infants. Mothers at 24 weeks gestation or greater and their infants will be randomized to receive either saline or one of two different doses of NAC within 4 hours of a clinical diagnosis of chorioamnionitis. NAC will be given to the mothers every 6 hours until delivery and every 12 hours to the infants after delivery for 2 days. Information gained from this trial will be used to determine the best dose of NAC and to help estimate effect and sample sizes for a subsequent large clinical trial.


Criteria:

Inclusion Criteria: Participants must have 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 Criteria: Participants must have none of the following: - Asthma - 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


NCT ID:

NCT00724594


Primary Contact:

Principal Investigator
Dorothea D. Jenkins, MD
Medical University of South Carolina

Deanna Fanning, RN
Phone: 843-792-7021
Email: fanningd@musc.edu


Backup Contact:

Email: lgrollins@gmail.com
Laura Grace Rollins
Phone: 843-792-7965


Location Contact:

Charleston, South Carolina 29425
United States

Deanna Fanning, RN
Phone: 843-792-7021
Email: fanningd@musc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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