Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers

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.

Primary Outcome

Panel 120 enables ultrasensitive, multiplexed quantification of 120+ neuro-specific and inflammatory proteins from just 10 µL (25 µL input) of umbilical cord blood. Panel 120 can detect and track key biomarkers of amyloid and tau pathologies, synaptic function, neurodegeneration, and inflammation in a single panel with unmatched precision and reproducibility. With assays specific the brain-derived Tau isoforms (pTau217, pTau181, pTau231, and tTau), the panel provides a comprehensive view of tau

Interventions

• OTHER Standard obstetric care at discretion of delivery provider
• DEVICE Intrauterine Pressure Catheter