Body Positioning for Premature Birth

Overseen By Mitchell Kresch, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Congenital heart disease, Pulmonary hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 hours

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

Who Is on the Research Team?

Kristin Glass, MD

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for premature infants born at or before 32 weeks of gestation who are stable on non-invasive NAVA ventilation for over 24 hours. It's not suitable for babies with conditions like persistent pulmonary hypertension, contraindications to NAVA, esophageal issues, or congenital heart disease.

Inclusion Criteria

My baby was born at or before 32 weeks and is on a non-invasive breathing support.

The baby must be using NAVA for at least 24 hours before joining the study and be doing well.

Exclusion Criteria

Infants who cannot use NAVA due to certain medical conditions or cannot have a tube placed in their nose or mouth will not be included.

My infant has persistent pulmonary hypertension.

My infant has a heart condition present at birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants are positioned in either supine or prone positions to assess the effect on breathing workload and oxygenation

12 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine

Trial Overview The study examines the effects of prone (lying face down) versus supine (lying on the back) body positions in premature infants using non-invasive NAVA. Researchers will assess breathing effort, oxygen and carbon dioxide levels, lung volume and compliance, and frequency of events like apnea.

How Is the Trial Designed?

Group I: Prone positioning Experimental Treatment 1 Intervention

Group II: Supine positioning Active Control 1 Intervention

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+