Amnioinfusion for Infant Respiratory Distress Syndrome
(PEARL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a procedure called amnioinfusion can help newborns breathe better when thick meconium is present in the amniotic fluid during labor. Meconium in the amniotic fluid can cause serious breathing problems for newborns. Participants will be randomly assigned to receive either the amnioinfusion treatment or standard care without it. Pregnant individuals must be at least 36 weeks along with a confirmed presence of thick meconium in the amniotic fluid to join. The trial will also examine signs of inflammation in the umbilical cord blood and monitor the child's development up to 12 months after birth. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving newborn care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this amnioinfusion protocol is safe for newborns?
Research shows that amnioinfusion, the process of adding fluid into the uterus, has been studied for its potential to help newborns with breathing problems caused by thick meconium. Previous studies suggest this technique can reduce breathing issues in newborns. However, those studies had limitations, such as inconsistent methods and measurement of important health markers.
Amnioinfusion is generally well-tolerated and usually doesn't cause serious side effects. Significant harm to mothers or babies from the fluid infusion itself has not been reported. Since this treatment has been studied before, there is considerable confidence in its safety. However, every medical procedure carries some risk, making ongoing research crucial to ensure safety and effectiveness.12345Why are researchers excited about this trial?
Researchers are excited about amnioinfusion for Infant Respiratory Distress Syndrome because it offers a novel approach to managing this condition. Unlike the standard care, which typically involves supportive measures and ventilation, amnioinfusion directly targets the problem by infusing a warm saline solution into the uterus. This method helps clear meconium and improves amniotic fluid levels, potentially reducing complications for the newborn. By focusing on enhancing the in-utero environment, this technique might offer immediate benefits to infants at risk of respiratory issues after birth.
What evidence suggests that amnioinfusion might be an effective treatment for infant respiratory distress syndrome?
Research has shown that amnioinfusion, which involves adding sterile fluid into the womb, may help newborns breathe better. In this trial, participants may receive a warm lactated Ringer amnioinfusion. Studies have linked this treatment to improved lung function and higher survival rates in newborns. Some research also suggests it can reduce the need for cesarean deliveries. By helping to clear thick meconium (a baby's first stool) from the amniotic fluid, amnioinfusion might lower the risk of serious breathing problems after birth. Although past studies had some limitations, these findings provide promising evidence of its potential benefits.16789
Are You a Good Fit for This Trial?
This trial is for pregnant individuals at or beyond 36 weeks of gestation with thick meconium-stained amniotic fluid. They must be confirmed using 'meconium-crit'. The study excludes those not meeting these specific conditions, but detailed exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either warm lactated Ringer's amnioinfusion or standard care without amnioinfusion during labor
Immediate Follow-up
Neonatal respiratory morbidity is assessed within 72 hours after birth
Long-term Follow-up
Families are contacted when the child is 12 months old to complete a developmental questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Amnioinfusion
Trial Overview
The PEARL Trial tests if warm lactated Ringer's (LR) amnioinfusion can reduce newborn breathing problems compared to standard care without amnioinfusion. It involves a standardized protocol and measures inflammation markers and potential brain injury through cord blood analysis.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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. Re-administration is permitted if thick meconium persists or the deepest amniotic fluid pocket is \<2 cm by ultrasound.
Standard obstetric care will be at the discretion of the delivery provider.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
The Gerber Foundation
Collaborator
Citations
Amnioinfusion's Protective Effects on Respiratory and ...
The main goal is to determine whether warm LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical ...
Serial amnioinfusions as a regenerative therapy for ...
Potential benefits of amnioinfusion: improved postnatal pulmonary function and increased neonatal survival rates, thereby potentially allowing ...
Amnioinfusion: a review
Randomized studies comparing amnioinfusion to no therapy have shown that amnioinfusion is associated with lower cesarean delivery rates, decreased numbers of ...
Respiratory Distress in the Newborn
Prenatal administration of corticosteroids between 24 and 34 weeks' gestation reduces the risk of respiratory distress syndrome of the newborn ...
Neonatal Survival After Serial Amnioinfusions for Bilateral ...
This prospective, nonrandomized clinical trial assesses neonatal outcomes after serial amnioinfusions initiated before 26 weeks' gestation ...
Serial Amnioinfusion as Regenerative Therapy for Pulmonary ...
In conclusion, SAT may provide fetal pulmonary palliation by reducing the risk of newborn pulmonary compromise secondary to oligohydramnios.
Neonatal Respiratory Distress Syndrome - StatPearls - NCBI
Neonatal respiratory distress syndrome, or RDS, is a common cause of respiratory distress in a newborn, presenting within hours after birth.
New developments in neonatal respiratory management
INSURE was successful in approximately 30% of preterm infants below 32 weeks of gestational age, while those failed INSURE required longer periods of ...
Respiratory Management of the Preterm Infant
The aim of these authors was to evaluate respiratory failure leading to additional ventilatory support in preterm infants with respiratory distress syndrome ( ...
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