Prophylactic CPAP for Late Preterm Infants Born by C-Section to Reduce NICU Admission

ClinicalTrials.gov ID: NCT07929506

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Official title

Prophylactic CPAP for Late Preterm Infants Born by C-Section to Reduce NICU Admission: A Multicenter Randomized Controlled Trial (PLaNT 2 Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07929506
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Indiana University; Other
Enrollment: 300 participants

Conditions and interventions

Conditions

Late Preterm Infant

Interventions

Prophylactic CPAP Other
Standard of Care Other

Other

Eligibility (public fields only)

Age range: 0 Minutes to 5 Minutes
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2027 (Estimated)
Primary completion: Jan 2029 (Estimated)
Completion: Jul 2029 (Estimated)
Last update posted: Nov 10, 2026

2027 – 2029

United States locations

U.S. sites: 6
U.S. states: 5
U.S. cities: 6

Facility	City	State	ZIP	Site status
Women and Infants Center, UAB	Birmingham	Alabama	35233	—
UC Davis Medical Center	Sacramento	California	95817	—
Sharp Mary Birch Hospital for Women & Newborns	San Diego	California	92123-2700	—
Riley Hospital	Indianapolis	Indiana	46202	—
SSM Health St. Mary's Hospital	St Louis	Missouri	63104	—
Children'S Hospital Oklahoma City	Oklahoma City	Oklahoma	73104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07929506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 15, 2026