Recruiting

Amnioinfusion

Sponsor:

Medical College of Wisconsin

Code:

NCT07610642

Conditions

Chorioamnionitis Affecting Fetus or Newborn

Amnioinfusion

Neonatal Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intrauterine Pressure Catheter

Standard obstetric care at discretion of delivery provider

Study Details

Brief 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

Study ID

NCT07610642

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Maternal age ≥18 years
  • Singleton gestation
  • Gestational age ≥36 weeks
  • Labor at time of enrollment
  • Clinical chorioamnionitis or intra-amniotic infection defined according to ACOG criteria, including: Maternal temperature ≥38.0°C At least one associated clinical finding, including:
  • 1\. Maternal leukocytosis
  • 2\. Purulent cervical drainage
  • 3\. Fetal tachycardia
  • Cervical dilation sufficient for intrauterine pressure catheter placement
  • Ability to provide informed consent

Exclusion Criteria:

  • Multifetal gestation
  • Known major fetal anomaly
  • Contraindication to vaginal delivery
  • Placenta previa
  • Category III fetal heart tracing requiring immediate delivery
  • Non-English-speaking

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Standard of Care

Standard obstetric care will be at the discretion of the delivery provider.

experimental: Room Temperature Lactated Ringer Amnioinfusion

Standardized room temperature amnioinfusion consisting of a 500 mL 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.

Interventions

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.

Standard obstetric care at discretion of delivery provider

Route obstetric care at the discretion of delivery provider.

Primary outcome measure

  • S100B measured through NULISAseq CNS Disease Panel 120 [ Time Frame: At delivery and/or part of routine childhood care through the first year of life. ]

Central Contacts and Locations

Central contacts

Brock E Polnaszek, MD,MPH

(414)-805-6600bpolnaszek@mcw.edu

Locations

Froedtert Hospital and Medical College of Wisconsin Birth Center

Recruiting

Milwaukee, Wisconsin, United States, 53045

Contacts

Brock E Polnaszek, MD,MPH

414-805-6600bpolnaszek@mcw.edu

Principal Investigator:

Brock E Polnaszek, MD,MPH

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Amnioinfusion
  • Neonatal morbidity
  • Maternal morbidity
  • Umbilical cord gas
  • Healthcare Utilization
  • Neonatal hypoxic brain injury
  • Chorioamnionitis
  • Neonatal brain biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.