Chorioamnionitis Affecting Fetus or NewbornAMNIO-BRAINNCT07610642
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
A study testing Intrauterine Pressure Catheter and Standard obstetric care at discretion of delivery provider in people with Chorioamnionitis Affecting Fetus or Newborn and Amnioinfusion, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion, Neonatal Brain Injury
- What is being tested?
- Intrauterine Pressure Catheter and Standard obstetric care at discretion of delivery provider
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 2. Purulent cervical drainage
- 3. Fetal tachycardia
- Cervical dilation sufficient for intrauterine pressure catheter placement
- Ability to provide informed consent
Who cannot join
- Multifetal gestation
- Known major fetal anomaly
- Contraindication to vaginal delivery
- Placenta previa
- Category III fetal heart tracing requiring immediate delivery
- Non-English-speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital and Medical College of Wisconsin Birth Center
Milwaukee, Wisconsin, 53045
Brock E Polnaszek, MD,MPH, 414-805-6600, bpolnaszek@mcw.edu
Brock E Polnaszek, MD,MPH
About this study
Official title: The AMNIO-BRAIN Trial: A Randomized Trial of Amnioinfusion for Chorioamnionitis Targeting Neonatal Brain Injury Biomarkers
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.
Read more
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.
Read the detailed description
The AMNIO-BRAIN Trial is designed to investigate whether intrapartum amnioinfusion, administered during labor, for patients with clinical chorioamnionitis can reduce molecular biomarkers of neonatal brain injury at birth. This study builds upon pilot randomized trial data demonstrating that room-temperature amnioinfusion lowers intrauterine temperature and is associated with reductions in umbilical artery lactate, a validated marker of anaerobic metabolism and tissue injury.
Current understanding of neonatal brain injury suggests that neurologic injury evolves through several biologic phases. During the initial or "priming" phase: inflammatory signaling, oxidative stress, mitochondrial dysfunction, and excitotoxicity contribute to neuronal injury before the latent and secondary injury phases occur. Clinical chorioamnionitis and maternal intrapartum fever are strongly associated with activation of these inflammatory pathways and may significantly worsen fetal neurologic injury.
Experimental animal data and translational studies suggest that early cooling during the priming phase may attenuate downstream neuronal injury. However, currently available neuroprotective therapies are initiated only after birth. Therefore, interventions capable of modulating intrauterine temperature and inflammation during labor may represent an important opportunity for earlier neuroprotection.
This prospective, randomized, controlled trial will enroll 80 maternal-infant dyads at ≥36 weeks' gestation with clinical chorioamnionitis. Participants will be randomized to either intrapartum amnioinfusion using room-temperature lactated Ringer's solution or standard obstetric care without amnioinfusion. The primary outcome will be umbilical artery cord blood concentration of S100B. S100D is a validated astroglia-specific biomarker associated with hypoxic-ischemic encephalopathy, MRI-confirmed neonatal brain injury, and adverse long-term neurodevelopmental outcomes. Secondary analyses will evaluate additional biomarkers of neurologic injury and inflammation, including GFAP, Tau, and IL-6, in addition to neonatal and maternal clinical outcomes.
Cord blood samples will undergo advanced proteomic analysis using the NULISAseq CNS Disease Panel, an innovative platform capable of attomolar -level biomarker detection. This study seeks to establish biologic plausibility for intrapartum neuroprotection and generate critical preliminary data for future definitive trials targeting neonatal neurologic outcomes.
- Being tested
- Intrauterine Pressure Catheter, Standard obstetric care at discretion of delivery provider
- Keywords
- Amnioinfusion, Neonatal morbidity, Maternal morbidity, Umbilical cord gas, Healthcare Utilization, Neonatal hypoxic brain injury, Chorioamnionitis, Neonatal brain biomarkers
- Medical subject headings
- Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Pressure CatheterDevice
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 providerOther
Route obstetric care at the discretion of delivery provider.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Standard obstetric care will be at the discretion of the delivery provider. Receives: 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. Receives: Device: Intrauterine Pressure Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery and/or part of routine childhood care through the first year of life.
Secondary outcomes (14)
Concentration of umbilical cord gas values
Umbilical cord gases including pH, lactate, base excess will be assessed.
Measured: At delivery
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
Measured: After delivery though 6 weeks postpartum
Time to defervesence
Evaluate the time of birthing person becoming afebrile from her maximum temperature collected intrapartum following the intervention.
Measured: At delivery/birth
Feasibility metrics
Evaluate feasibility metrics including number of patients approached, consented, randomized and followed to completion
Measured: From consent to 1 year postpartum
Scores on developmental screening
Will predominately capture standard developmental screening including the Ages and Stages Questionnaires through 1 year of life. Additional developmental screening including Sarnat score and referral to subspecialists will be tracked as well.
Measured: 1 year after delivery
Number of participants with composite maternal morbidity
Composite maternal morbidity consisting of amniotic fluid embolism, acute respiratory distress syndrome, pulmonary edema, intubation, PPH > 1000 milliliters including intervention such as estimated blood loss >1000 milliliters (mL) or uterotonics, tranexamic acid, blood transfusion or surgical interventions (dilation and curettage, Bakri, Jadha, laparotomy, interventional radiology), blood transfusion, hysterectomy, diffuse intravascular coagulation, endometritis, intraamniotic infection, maternal sepsis with culture, and death.
Measured: Hospitalization through 6 weeks postpartum
Number of participants in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Electronic (NICHD) Fetal Monitoring categories
Using standard NICHD data, we will collect and analyze standard electronic fetal monitoring data after randomization including things like rates of tachysystole, categories, declarations, total deceleration area, variability, and accelerations
Measured: During labor and delivery
Decisional Self Efficacy (DSE)
DSE measures self-confidence or belief in one's abilities in decision making, including shared-decision making for participating in trial. The 5-point scale, items are summed, divided by 11, multiplied by 25, and scores range from 0 [not at all confident] to 100 [very confident].
Measured: At delivery/birth
Labor Agentry Scale (LAS)
The Labour Agentry Scale (LAS) is a validated, unifactorial, 29-item or 10-item instrument measuring a person's perceived control, confidence, and positive experiences during childbirth. It uses a 7-point Likert scale (1 = never to 7 = almost always) to assess personal agency, with higher scores reflecting higher levels of control.
Measured: At delivery/birth
Value of neonatal temperature
The temperature of the baby at the time of delivery and route of collection (axillary, oral, or rectal) will be collected and reported.
Measured: At delivery/birth
Number of childhood participants with healthcare utilization
Capturing all hospitalizations, emergency room visits, subspeciality referrals, ancillary referrals, and follow-up visits in the first year of life.
Measured: 1 year after delivery
Maternal intraamniotic infection treatment success
Defined as resolution of fever within 16 hours of antibiotic administration and the absence of endometritis through 6 weeks postpartum.
Measured: Delivery hospitalization until 6 weeks postpartum
Number of childhood participants with healthcare utilization
Capturing all hospitalizations, emergency room visits, subspeciality referrals, ancillary referrals, and follow-up visits in the first year of life
Measured: 1 year after delivery
Number of maternal participants with healthcare utilization
Capturing all hospitalizations, emergency room visits, subspeciality referrals, ancillary referrals, and follow-up visits in the first year of life.
Measured: From delivery until 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start15 Oct 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chorioamnionitis Affecting Fetus or NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brock E. Polnaszek, MD MPH, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610642
- Sponsor's protocol ID
- PRO00059233
- Acronym
- AMNIO-BRAIN
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD data at this time is not a part of our consent process but may be considered on a case-by-case basis with contacting the principal investigator (e.g. a metanalysis) with de-identified data.
Publications
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.
PubMed 39117278
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AMNIO-BRAIN Trial: A Randomized Trial of Amnioinfusion for Chorioamnionitis Targeting Neonatal Brain Injury Biomarkers
- ClinicalTrials.gov ID
- NCT07610642
- Acronym / sponsor ID
- AMNIO-BRAIN / PRO00059233
- Keywords
- Amnioinfusion, Neonatal morbidity, Maternal morbidity, Umbilical cord gas, Healthcare Utilization, Neonatal hypoxic brain injury, Chorioamnionitis, Neonatal brain biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The AMNIO-BRAIN Trial is designed to investigate whether intrapartum amnioinfusion, administered during labor, for patients with clinical chorioamnionitis can reduce molecular biomarkers of neonatal brain injury at birth. This study builds upon pilot randomized trial data demonstrating that room-temperature amnioinfusion lowers intrauterine temperature and is associated with reductions in umbilical artery lactate, a validated marker of anaerobic metabolism and tissue injury.
Current understanding of neonatal brain injury suggests that neurologic injury evolves through several biologic phases. During the initial or "priming" phase: inflammatory signaling, oxidative stress, mitochondrial dysfunction, and excitotoxicity contribute to neuronal injury before the latent and secondary injury phases occur. Clinical chorioamnionitis and maternal intrapartum fever are strongly associated with activation of these inflammatory pathways and may significantly worsen fetal neurologic injury.
Experimental animal data and translational studies suggest that early cooling during the priming phase may attenuate downstream neuronal injury. However, currently available neuroprotective therapies are initiated only after birth. Therefore, interventions capable of modulating intrauterine temperature and inflammation during labor may represent an important opportunity for earlier neuroprotection.
This prospective, randomized, controlled trial will enroll 80 maternal-infant dyads at ≥36 weeks' gestation with clinical chorioamnionitis. Participants will be randomized to either intrapartum amnioinfusion using room-temperature lactated Ringer's solution or standard obstetric care without amnioinfusion. The primary outcome will be umbilical artery cord blood concentration of S100B. S100D is a validated astroglia-specific biomarker associated with hypoxic-ischemic encephalopathy, MRI-confirmed neonatal brain injury, and adverse long-term neurodevelopmental outcomes. Secondary analyses will evaluate additional biomarkers of neurologic injury and inflammation, including GFAP, Tau, and IL-6, in addition to neonatal and maternal clinical outcomes.
Cord blood samples will undergo advanced proteomic analysis using the NULISAseq CNS Disease Panel, an innovative platform capable of attomolar -level biomarker detection. This study seeks to establish biologic plausibility for intrapartum neuroprotection and generate critical preliminary data for future definitive trials targeting neonatal neurologic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Other: Standard obstetric care at discretion of delivery providerStandard obstetric care will be at the discretion of the delivery provider. |
| Room Temperature Lactated Ringer Amnioinfusion | Experimental | Device: Intrauterine Pressure CatheterStandardized 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (6 listed)
- Multifetal gestation
- Known major fetal anomaly
- Contraindication to vaginal delivery
- Placenta previa
- Category III fetal heart tracing requiring immediate delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine Pressure CatheterStandardized 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. | Device | Room Temperature Lactated Ringer Amnioinfusion |
| Standard obstetric care at discretion of delivery providerRoute obstetric care at the discretion of delivery provider. | Other | Standard of Care |
Primary outcome
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.
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.
14 secondary outcomes
Concentration of umbilical cord gas values
Time frame: At delivery
Number of participants with composite neonatal respiratory morbidity
Time frame: After delivery though 6 weeks postpartum
Time to defervesence
Time frame: At delivery/birth
Feasibility metrics
Time frame: From consent to 1 year postpartum
Scores on developmental screening
Time frame: 1 year after delivery
Number of participants with composite maternal morbidity
Time frame: Hospitalization through 6 weeks postpartum
Number of participants in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Electronic (NICHD) Fetal Monitoring categories
Time frame: During labor and delivery
Decisional Self Efficacy (DSE)
Time frame: At delivery/birth
Labor Agentry Scale (LAS)
Time frame: At delivery/birth
Value of neonatal temperature
Time frame: At delivery/birth
Number of childhood participants with healthcare utilization
Time frame: 1 year after delivery
Maternal intraamniotic infection treatment success
Time frame: Delivery hospitalization until 6 weeks postpartum
Number of childhood participants with healthcare utilization
Time frame: 1 year after delivery
Number of maternal participants with healthcare utilization
Time frame: From delivery until 1 year postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 39117278Polnaszek 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.
- Individual participant dataSharing planned: No. IPD data at this time is not a part of our consent process but may be considered on a case-by-case basis with contacting the principal investigator (e.g. a metanalysis) with de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Pressure Catheter and Standard obstetric care at discretion of delivery provider in people with Chorioamnionitis Affecting Fetus or Newborn and Amnioinfusion, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brock E Polnaszek, MD,MPH ((414)-805-6600, bpolnaszek@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07610642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.