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Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers

ConditionsChorioamnionitis Affecting Fetus or NewbornAmnioinfusionNeonatal Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Maternal age ≥18 years

Singleton gestation

Gestational age ≥36 weeks

Labor at time of enrollment

Disqualifiers

Multifetal gestation

Known major fetal anomaly

Contraindication to vaginal delivery

Placenta previa

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Route obstetric care at the discretion of delivery provider.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standard of CarePlacebo comparator 1 intervention
Group B: Room Temperature Lactated Ringer AmnioinfusionExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Concentration of umbilical cord gas values

Umbilical cord gases including pH, lactate, base excess will be assessed.

Time frame
At delivery
2

Number of participants with composite neonatal respiratory morbidity

Composite neonatal morbidity including NICU admission, fever \>38 degree Celsius, therapeutic hypothermia, hypoxic-ischemic encephalopathy, seizures, intracranial hemorrhage and grade, hyperbilirubinemia requiring phototherapy, suspected and culture proven sepsis, antibiotics, respiratory distress, supplemental oxygen, mechanical ventilation, intubation, or neonatal death

Time frame
After delivery though 6 weeks postpartum
3

Time to defervesence

Evaluate the time of birthing person becoming afebrile from her maximum temperature collected intrapartum following the intervention.

Time frame
At delivery/birth
4

Feasibility metrics

Evaluate feasibility metrics including number of patients approached, consented, randomized and followed to completion

Time frame
From consent to 1 year postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: