Neonatal Respiratory Distress Related ConditionsPEARLNCT07274527
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
A study testing Intrauterine pressure catheter and Standard obstetric care at discretion of delivery provider in people with Neonatal Respiratory Distress Related Conditions and Meconium, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neonatal Respiratory Distress Related Conditions, Meconium, Perinatal Morbidity
- 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
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 15 Apr 2030
- 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 greater than or equal to 18 years old
- Singleton pregnancy
- Gestational age of greater than or equal to 36 weeks 0 days gestation
- Cephalic presentation
- Cercial dilation between 2-10 centimeters
- Meconium
Who cannot join
- Major fetal anomaly
- Multiple gestation
- Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing
- Contraindication to internal monitors
- Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent
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
Polnaszek Assistant Professor and Principal Investigator, MD MPH, 414-805-6600, bpolnaszek@mcw.edu
About this study
Official title: The PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension.
Although amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly present.
Read more
The PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop meconium-stained amniotic fluid, confirmed using a simple, objective measurement ("meconium-crit"). Participants will be randomly assigned to receive either:
Lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion.
The main goal is to determine whether LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice.
By using a clear definition of meconium, a LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.
Read the detailed description
Meconium-stained amniotic fluid is a common intrapartum finding and is associated with increased newborn respiratory morbidity, NICU admission, and long-term developmental concerns. Prior research on amnioinfusion for meconium produced mixed results, largely because earlier trials included all meconium consistencies, used different fluid types and temperatures, did not monitor adherence to infusion protocols, and did not study biologic markers or long-term child outcomes. Because of these limitations, clinicians lack clear evidence about whether modern, standardized amnioinfusion can benefit infants exposed to meconium.
The PEARL Trial is designed to address these gaps using a methodologically rigorous, implementation-science-informed approach. The study enrolls maternal-infant dyads at ≥ 36 weeks' gestation with confirmed meconium, defined both visually and using an objective "meconium-crit" method that measures the proportion of meconium in the amniotic fluid. After eligibility is confirmed, participants are randomized to receive either a structured lactated Ringer's (LR) amnioinfusion protocol or standard obstetric care with no amnioinfusion.
The intervention consists of a 500-mL bolus of LR infused over 30 minutes through an intrauterine pressure catheter, followed by a maintenance infusion until the meconium clears or delivery occurs. Ultrasound checks, infusion parameters, and fluid characteristics are recorded using a fidelity checklist to ensure consistent delivery of the intervention.
The primary outcome is a composite measure of neonatal respiratory morbidity within 72 hours of birth, including need for oxygen, continuous positive airway pressure (CPAP), intubation, inhaled nitric oxide, surfactant therapy, NICU admission, or perinatal death. At birth, umbilical cord blood is collected for gases and for a multiplex panel of inflammatory cytokines and S100B, a biomarker associated with neurologic injury, to better understand biologic pathways linking meconium exposure to newborn outcomes. The investigators will also track long-term childhood respiratory morbidity including asthma treatment and severity, reactive airway disease, persistent pulmonary hypertension, bronchopulmonary dysplasia, health care utilization outcomes including but not limited to subspecialty referral, ancillary referrals, emergency room and rehospitalizations.
Long-term follow-up occurs at 12 months corrected age using the Ages and Stages Questionnaire (ASQ-3), a validated tool that screens for communication, motor, problem-solving, and social-emotional development. This allows the trial to explore whether improved intrapartum intervention translates into better developmental outcomes.
- Conditions
- Neonatal Respiratory Distress Related Conditions, Meconium, Perinatal Morbidity, Neonatal Acidosis, Cord Blood, Neonatal Brain Injury
- Being tested
- Intrauterine pressure catheter, Standard obstetric care at discretion of delivery provider
- Keywords
- Amnioinfusion, Meconium, Neonatal morbidity, Developmental Screening, Maternal Morbidity, Neonatal respiratory morbidity, Umbilical cord gas and biomarkers, Healthcare Utilization
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine pressure catheterDevice
Also called Amnioinfusion
Standardized warm amnioinfusion consisting of a 500 mL bolus of warmed (37°C) lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL/hour until the amniotic fluid clears or delivery.
Standard obstetric care at discretion of delivery providerOther
Route obstetric care at discretion of delivery provider
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer Amnioinfusion | Experimental | Standardized amnioinfusion consisting of a 500 mL bolus of lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL/hour until the amniotic fluid clears or delivery. Re-administration is permitted if thick meconium persists or the deepest amniotic fluid pocket is <2 cm by ultrasound. Receives: Device: Intrauterine pressure catheter |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with composite neonatal respiratory morbidity
Composite neonatal respiratory morbidity including continuous positive airway pressure (CPAP) >6 hours, oxygen >24 hours, intubation, persistent pulmonary hypertension (PPHN), surfactant use, inhaled nitric oxide, extracorporeal membrane oxygenation (ECMO), neonatal intensive care unit (NICU) admission, or perinatal death.
Measured: 72 hours after delivery
Secondary outcomes (4)
Concentration of umbilical cord gas values
Umbilical cord gases including pH, lactate, base excess will be assessed.
Measured: At delivery
Concentration of umbilical cord blood biomarkers
Human Cytokine/Chemokine Panel A 48-Plex Discovery Assay® (HD48A; Eve Technologies) and other novel markers such as sCD40L, G-CSF, and IFNα2. Additionally, S100B as a validated marker for brain injury will be collected.
Measured: At delivery and if measured in the neonate as a part of usual care
Scores on developmental screening
Predominantly will capture standard developmental screening including the Ages and Stages Questionaires through 1 year of life. Additional information on developmental screening including Sarnat score and referral to subspecialists will be tracked.
Measured: 1 year after delivery
Number of participants with composite maternal morbidity
Composite morbidity will collect processes related to meconium including postpartum hemorrhage requiring intervention such as estimated blood loss >1000 mililiters (mL) or uterotonics, transexamic acid, blood transfusion or surgical interventions (dilation and curettage, Bakri, Jadha, laparotomy, interventional radiology), endometritis, intraamniotic infection, operative delivery (forceps, vaccum, cesarean), obstetric anal sphincter injury (OASIS), ICU admission, amniotic fluid embolism, and death.
Measured: Through 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start15 May 2026
- Primary completion15 Apr 2029 (estimated)
- Study completion15 Apr 2030 (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 Neonatal Respiratory Distress Related ConditionsStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Brock E. Polnaszek, MD MPH, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274527
- Sponsor's protocol ID
- PRO00054878
- Acronym
- PEARL
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Davis JD, Sanchez-Ramos L, McKinney JA, Lin L, Kaunitz AM. Intrapartum amnioinfusion reduces meconium aspiration syndrome and improves neonatal outcomes in patients with meconium-stained fluid: a systematic review and meta-analysis. Am J Obstet Gynecol. 2023 May;228(5S):S1179-S1191.e19. doi: 10.1016/j.ajog.2022.07.047. Epub 2023 Mar 18.
PubMed 37164492
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 PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
- ClinicalTrials.gov ID
- NCT07274527
- Acronym / sponsor ID
- PEARL / PRO00054878
- Conditions
- Neonatal Respiratory Distress Related Conditions, Meconium, Perinatal Morbidity, Neonatal Acidosis, Cord Blood, Neonatal Brain Injury
- Keywords
- Amnioinfusion, Meconium, Neonatal morbidity, Developmental Screening, Maternal Morbidity, Neonatal respiratory morbidity, Umbilical cord gas and biomarkers, Healthcare Utilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 10 Dec 2025 (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.
Meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension.
Although amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly present.
The PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop meconium-stained amniotic fluid, confirmed using a simple, objective measurement ("meconium-crit"). Participants will be randomly assigned to receive either:
Lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion.
The main goal is to determine whether LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice.
By using a clear definition of meconium, a LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.
Detailed description
Meconium-stained amniotic fluid is a common intrapartum finding and is associated with increased newborn respiratory morbidity, NICU admission, and long-term developmental concerns. Prior research on amnioinfusion for meconium produced mixed results, largely because earlier trials included all meconium consistencies, used different fluid types and temperatures, did not monitor adherence to infusion protocols, and did not study biologic markers or long-term child outcomes. Because of these limitations, clinicians lack clear evidence about whether modern, standardized amnioinfusion can benefit infants exposed to meconium.
The PEARL Trial is designed to address these gaps using a methodologically rigorous, implementation-science-informed approach. The study enrolls maternal-infant dyads at ≥ 36 weeks' gestation with confirmed meconium, defined both visually and using an objective "meconium-crit" method that measures the proportion of meconium in the amniotic fluid. After eligibility is confirmed, participants are randomized to receive either a structured lactated Ringer's (LR) amnioinfusion protocol or standard obstetric care with no amnioinfusion.
The intervention consists of a 500-mL bolus of LR infused over 30 minutes through an intrauterine pressure catheter, followed by a maintenance infusion until the meconium clears or delivery occurs. Ultrasound checks, infusion parameters, and fluid characteristics are recorded using a fidelity checklist to ensure consistent delivery of the intervention.
The primary outcome is a composite measure of neonatal respiratory morbidity within 72 hours of birth, including need for oxygen, continuous positive airway pressure (CPAP), intubation, inhaled nitric oxide, surfactant therapy, NICU admission, or perinatal death. At birth, umbilical cord blood is collected for gases and for a multiplex panel of inflammatory cytokines and S100B, a biomarker associated with neurologic injury, to better understand biologic pathways linking meconium exposure to newborn outcomes. The investigators will also track long-term childhood respiratory morbidity including asthma treatment and severity, reactive airway disease, persistent pulmonary hypertension, bronchopulmonary dysplasia, health care utilization outcomes including but not limited to subspecialty referral, ancillary referrals, emergency room and rehospitalizations.
Long-term follow-up occurs at 12 months corrected age using the Ages and Stages Questionnaire (ASQ-3), a validated tool that screens for communication, motor, problem-solving, and social-emotional development. This allows the trial to explore whether improved intrapartum intervention translates into better developmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer Amnioinfusion | Experimental | Device: Intrauterine pressure catheterStandardized amnioinfusion consisting of a 500 mL bolus of lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL/hour until the amniotic fluid clears or delivery. Re-administration is permitted if thick meconium persists or the deepest amniotic fluid pocket is <2 cm by ultrasound. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Maternal age greater than or equal to 18 years old
- Singleton pregnancy
- Gestational age of greater than or equal to 36 weeks 0 days gestation
- Cephalic presentation
- Cercial dilation between 2-10 centimeters
Key exclusion criteria (5 listed)
- Major fetal anomaly
- Multiple gestation
- Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing
- Contraindication to internal monitors
- Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent
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 catheterAlso: AmnioinfusionStandardized warm amnioinfusion consisting of a 500 mL bolus of warmed (37°C) lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL/hour until the amniotic fluid clears or delivery. | Device | Lactated Ringer Amnioinfusion |
| Standard obstetric care at discretion of delivery providerRoute obstetric care at discretion of delivery provider | Other | Standard of Care |
Primary outcome
Number of participants with composite neonatal respiratory morbidity
Time frame: 72 hours after delivery
Composite neonatal respiratory morbidity including continuous positive airway pressure (CPAP) >6 hours, oxygen >24 hours, intubation, persistent pulmonary hypertension (PPHN), surfactant use, inhaled nitric oxide, extracorporeal membrane oxygenation (ECMO), neonatal intensive care unit (NICU) admission, or perinatal death.
4 secondary outcomes
Concentration of umbilical cord gas values
Time frame: At delivery
Concentration of umbilical cord blood biomarkers
Time frame: At delivery and if measured in the neonate as a part of usual care
Scores on developmental screening
Time frame: 1 year after delivery
Number of participants with composite maternal morbidity
Time frame: Through 6 weeks 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 37164492Davis JD, Sanchez-Ramos L, McKinney JA, Lin L, Kaunitz AM. Intrapartum amnioinfusion reduces meconium aspiration syndrome and improves neonatal outcomes in patients with meconium-stained fluid: a systematic review and meta-analysis. Am J Obstet Gynecol. 2023 May;228(5S):S1179-S1191.e19. doi: 10.1016/j.ajog.2022.07.047. Epub 2023 Mar 18.
- 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.
Related trials for Neonatal Respiratory Distress Related Conditions
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Not yet recruiting
Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells - Intensive Care Unit
Glucose, Metabolism
Not yet recruitingPhase 4
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Infant, Premature, Intubation, Intratracheal
RecruitingObservational study
Physiological Studies in the Prone Position in Patients With ARDS
Acute Respiratory Distress Syndrome, Mechanical Ventilation
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.
Froedtert Hospital and Medical College of Wisconsin Birth Center
Milwaukee, United States
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 Neonatal Respiratory Distress Related Conditions and Meconium, 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 6 inclusion and 5 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with composite neonatal respiratory morbidity (time frame: 72 hours after delivery). 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 NCT07274527, 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.