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Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers

NCT07610642 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-29

No results posted yet for this 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.

Conditions

  • Chorioamnionitis Affecting Fetus or Newborn
  • Amnioinfusion
  • Neonatal Brain Injury

Interventions

DEVICE

Intrauterine Pressure Catheter

Standardized room temperature amnioinfusion consisting of a 500mL bolus of (24°C) lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL/hour. Infusion continues until 1L is infused or delivery occurs.

OTHER

Standard obstetric care at discretion of delivery provider

Route obstetric care at the discretion of delivery provider.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-11-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610642 on ClinicalTrials.gov