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NCT07610642 · ClinicalTrials.gov registry record · NA
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
A NA study, sponsored by Medical College of Wisconsin.
- Not yet
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT07610642 is a NA study that has not yet begun recruiting, run by Medical College of Wisconsin. The registered enrollment target is 80 participants.
The verdict
NCT07610642, a NA study, has not yet begun recruiting, sponsored by Medical College of Wisconsin.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the brain does not get enough oxygen or blood flow. This can lead to serious health problems, including developmental delays and lifelong disabilities. While there is a cooling treatment after birth that can help, it starts only after delivery and may come too late to prevent the earliest stages of injury. Research suggests that some brain injury may actually begin during labor, especially when there is an infection in the uterus called chorioamnionitis. This infection can cause inflammation and fever in the mother, which may increase stress on the baby and affect the baby's brain. This study is testing whether a commonly used labor procedure called amnioinfusion can help. Amnioinfusion involves placing fluid similar to your biologic amniotic fluid into the uterus during labor. It is already used safely in many deliveries for other reasons. In prior research, this treatment slightly lowered the temperature inside the uterus and improved signs that the baby was no longer under stress. In this study, 80 pregnant subjects with chorioamnionitis will be randomly assigned to receive amnioinfusion during labor or receive standard care without amnioinfusion. All patients will continue to receive normal treatment for infection. After delivery, researchers will collect a small sample of blood from the umbilical cord. This blood will be tested for markers that can show whether the baby may have experienced stress or injury to the brain.
Interventions
- OTHER Standard obstetric care at discretion of delivery provider
- DEVICE Intrauterine Pressure Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2027-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07610642
The ClinicalTrials.gov registry entry for NCT07610642 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard obstetric care at discretion of delivery provider is the first listed.
NCT07610642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07610642 about?
NCT07610642 is a clinical study titled "Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers". The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the brain does not get enough oxygen or blood flow. This can lead to serio...
What is the current status of trial NCT07610642?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2026-07-01. Estimated completion is 2027-12.
What interventions are being tested in trial NCT07610642?
The interventions under investigation include: Standard obstetric care at discretion of delivery provider (OTHER), Intrauterine Pressure Catheter (DEVICE).
Who is sponsoring clinical trial NCT07610642?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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