Prophylactic CPAP for Preterm Infants
(PLaNT2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The PLaNT 2 study will test whether giving breathing support soon after birth can help late preterm babies born by cesarean section (C-section). The goal is to lower breathing problems and the need for admission to the neonatal intensive care unit (NICU).
Late preterm babies are born a few weeks before their due date. They have a higher risk of breathing problems after birth, especially after a C-section. A recent international pilot study showed promising results with early breathing support in these babies. A larger study is now needed to find out if this approach works.
Continuous positive airway pressure (CPAP) is a common form of breathing support for newborns. It provides gentle air pressure through a mask or nasal prongs. CPAP is usually given after a baby develops breathing problems. PLaNT 2 will test giving CPAP shortly after birth, before breathing problems develop.
The study will include 300 babies born by C-section at 35 to 36 weeks of pregnancy. Babies who are breathing on their own within 5 minutes after birth may take part. The study will randomly assign babies to one of two groups:
* One group will receive 20 minutes of CPAP shortly after birth.
* The other group will receive the hospital's usual care. Babies in either group can receive CPAP or other breathing support later if they need it.
The main question is whether early CPAP lowers the number of babies admitted to the NICU for breathing support. Researchers will also look at the need for breathing support after birth. They will study parental stress, bonding between mothers and babies, and exclusive breastfeeding.
If this approach works, it could lower breathing problems and unnecessary NICU admissions. This could allow more babies to stay with their families. CPAP is already available in many hospitals, so this approach could be used in different health care settings around the world. It may also support early bonding, breastfeeding, and family-centered newborn care.
Who Is on the Research Team?
Edgardo Szyld, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for late preterm babies (born at 35–36 weeks) delivered by C-section who are breathing on their own within 5 minutes after birth. Babies with serious health issues or not meeting these criteria cannot join.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Prophylactic CPAP
Trial Overview
The study compares giving CPAP (gentle breathing support) soon after birth versus standard care in late preterm infants born by C-section. Babies are randomly assigned to either early CPAP for 20 minutes or usual hospital care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants assigned to this arm will receive 20 minutes of prophylactic continuous positive airway pressure (CPAP) at 5 to 6 cm H2O, started within 5 minutes after birth. CPAP may be provided at the radiant warmer or while the infant is on the mother's chest. Participants may receive additional CPAP or other respiratory support if clinically needed.
Participants assigned to this arm will receive standard care after birth without prophylactic CPAP. CPAP or other respiratory support may be provided if clinically needed according to usual clinical care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Thrasher Research Fund
Collaborator
University of Oklahoma
Collaborator
University of Alabama at Birmingham
Collaborator
Pontificia Universidad Catolica de Chile
Collaborator
University of Alberta
Collaborator
University of Bristol
Collaborator
St. Louis University
Collaborator
University of Valencia
Collaborator
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