drugset / Trial / NCT00724594
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Phase 1/2
Completed
46 enrolled
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2008-08
- Primary completion
- 2014-07
- Completion
- 2014-08
Publications
- Results Wiest DB, Chang E, Fanning D, Garner S, Cox T, Jenkins DD. Antenatal pharmacokinetics and placental transfer of N-acetylcysteine in chorioamnionitis for fetal neuroprotection. J Pediatr. 2014 Oct;165(4):672-7.e2. doi: 10.1016/j.jpeds.2014.06.044. Epub 2014 Jul 23.
- Jenkins DD, Wiest DB, Mulvihill DM, Hlavacek AM, Majstoravich SJ, Brown TR, Taylor JJ, Buckley JR, Turner RP, Rollins LG, Bentzley JP, Hope KE, Barbour AB, Lowe DW, Martin RH, Chang EY. Fetal and Neonatal Effects of N-Acetylcysteine When Used for Neuroprotection in Maternal Chorioamnionitis. J Pediatr. 2016 Jan;168:67-76.e6. doi: 10.1016/j.jpeds.2015.09.076. Epub 2015 Nov 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | N-acetylcysteine | Small molecule | 12.5 mg/kg | — |
| Subject | N-acetylcysteine | Small molecule | 25 mg/kg | — |
| Subject | N-acetylcysteine | Small molecule | 100 mg/kg | — |