Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers

NCT07610642 | Not Yet Recruiting FDA Device

• 1 other identifier: PRO00059233
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• S100B measured through NULISAseq CNS Disease Panel 120

  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 pathology from blood with unprecedented sensitivity and specificity, as well as S100B for brain specific brain injury.

  At delivery and/or part of routine childhood care through the first year of life.

Secondary Outcomes (14)

• Concentration of umbilical cord gas values

  At delivery

• Number of participants with composite neonatal respiratory morbidity

  After delivery though 6 weeks postpartum

• Time to defervesence

  At delivery/birth

• Feasibility metrics

  From consent to 1 year postpartum

• Scores on developmental screening

  1 year after delivery

Study Arms (2)

Standard of Care

PLACEBO COMPARATOR

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

Other: Standard obstetric care at discretion of delivery provider

Room Temperature Lactated Ringer Amnioinfusion

EXPERIMENTAL

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.

Device: Intrauterine Pressure Catheter

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.

Room Temperature Lactated Ringer Amnioinfusion

Standard obstetric care at discretion of delivery provider OTHER

Route obstetric care at the discretion of delivery provider.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Maternal leukocytosis
• \. Purulent cervical drainage
• \. Fetal tachycardia
• Cervical dilation sufficient for intrauterine pressure catheter placement
• Ability to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and Medical College of Wisconsin Birth Center

Milwaukee, Wisconsin, 53045, United States

Location

Related Publications (1)

• Polnaszek BE, Rossen J, Scarpaci M, Murphy LM, Whelan AR, Hamel M, Rouse DJ, Tuuli MG, Lewkowitz AK. Amnioinfusion for reducing umbilical artery lactate among fetuses at risk of neurologic injury: a pilot randomized clinical trial. Am J Obstet Gynecol MFM. 2024 Oct;6(10):101446. doi: 10.1016/j.ajogmf.2024.101446. Epub 2024 Aug 8. No abstract available.

  PMID: 39117278 BACKGROUND

MeSH Terms

Conditions

Chorioamnionitis

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Brock E Polnaszek, MD,MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Primary Investigator MD, MPH

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)