Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intrauterine Pressure Catheter — DEVICE
  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 — OTHER
  Route obstetric care at the discretion of delivery provider.

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

May 2026

Primary completion

Nov 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Brock E Polnaszek, MD,MPH
  (414)-805-6600
  [email protected]

Locations (1)

Find similar trials in Milwaukee, WI

Related Studies

• Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure
  Recruiting · Medical College of Wisconsin · Milwaukee, Wisconsin