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Body Positioning for Premature Birth
N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment in study to end of study (a total of twelve hours)
Awards & highlights
Study Summary
This trial is studying how body position affects a baby's breathing, oxygen, carbon dioxide, lung volume, and more.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves body positioning rather than medication, there aren't typical drug side effects. However, changes in position could potentially affect an infant's breathing patterns or stability.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born at or before 32 weeks and is on a non-invasive breathing support.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment in study to end of study (a total of twelve hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment in study to end of study (a total of twelve hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimum electrical activity of the diaphragm (Edi mins)
Number of apenic events
Number of bradycardia events
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prone positioningExperimental Treatment1 Intervention
Group II: Supine positioningActive Control1 Intervention
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
497 Previous Clinical Trials
2,799,940 Total Patients Enrolled
Kristin Glass, MDStudy DirectorPenn State College of Medicine
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Eligibility Criteria:
This trial includes the following eligibility 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 baby was born at or before 32 weeks and is on a non-invasive breathing support.My infant has persistent pulmonary hypertension.My infant has a heart condition present at birth.The baby must be using NAVA for at least 24 hours before joining the study and be doing well.
Research Study Groups:
This trial has the following groups:- Group 1: Prone positioning
- Group 2: Supine positioning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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