Prophylactic CPAP for Preterm Infants

(PLaNT2 Trial)

Not yet recruiting at 9 trial locations
ES
AT
Overseen ByAnna Thomas, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

ES

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

Inborn newborns delivered by cesarean section (with or without labor)
Gestational age 35⁰⁄₇ to 36⁶⁄₇ weeks by best obstetrical estimate
Spontaneously breathing within 5 minutes after birth

Exclusion Criteria

Major congenital anomalies

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

Group I: Prophylactic CPAPExperimental Treatment1 Intervention
Group II: STANDARD CAREActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Thrasher Research Fund

Collaborator

Trials
135
Recruited
96,600+

University of Oklahoma

Collaborator

Trials
484
Recruited
95,900+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Pontificia Universidad Catolica de Chile

Collaborator

Trials
221
Recruited
165,000+

University of Alberta

Collaborator

Trials
957
Recruited
437,000+

University of Bristol

Collaborator

Trials
114
Recruited
25,030,000+

St. Louis University

Collaborator

Trials
197
Recruited
41,400+

University of Valencia

Collaborator

Trials
352
Recruited
54,000+