Body Positioning for Premature Birth

ND
MK
Overseen ByMitchell Kresch, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center
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?

This trial examines how different body positions affect the breathing effort of premature babies. It compares two positions: lying on their back (supine) and lying on their tummy (prone) to assess impacts on breathing effort, oxygen and carbon dioxide levels, lung volume, and the frequency of breathing problems like apnea (when the baby stops breathing). Babies born at or before 32 weeks who have used a non-invasive breathing assistance method called Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) for at least 24 hours qualify as candidates for this study. The researchers aim to determine if changing positions can make breathing easier and safer for these infants. As an unphased trial, this study provides a unique opportunity to understand how simple interventions can improve breathing in premature infants.

Do I need to stop my baby's current medications for the trial?

The trial information does not specify whether you need to stop your baby's current medications. It's best to discuss this with the trial coordinators or your baby's doctor.

What prior data suggests that this body positioning technique is safe for premature infants?

Research has shown that Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) is safe and well-tolerated for helping preterm infants breathe. Studies have found that this method eases breathing by adjusting support based on the infants' own efforts, reducing the risk of breathing problems.

Reports indicate that NAVA improves how well the machine aligns with the baby's natural breathing, allowing it to work smoothly with the baby's attempts to breathe. One study found that babies using NAVA had similar success in staying off breathing tubes compared to other methods, but experienced fewer breathing issues.

These findings suggest that NAVA is a safe option for assisting preterm babies with breathing, focusing on providing the right amount of help without overwhelming their system.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of different body positioning techniques, prone and supine, on premature infants receiving Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA). Unlike other treatments that primarily focus on medication or invasive procedures, this trial investigates how simple changes in body position might enhance breathing support. The prone positioning technique, in particular, could potentially improve lung function and oxygenation by allowing better expansion of the lungs. This trial aims to provide insights that could lead to more effective and non-invasive care strategies for premature babies.

What evidence suggests that this trial's body positioning techniques could be effective for premature infants?

Research has shown that Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) can help preterm infants breathe more easily. Studies have found it to be a safe and effective method for supporting their breathing. NAVA helps the ventilator align with the baby's natural breathing efforts, potentially leading to better health outcomes. Specifically, it has improved lung function and reduced the risk of breathing issues. This trial tests NAVA with babies in two positions: lying on their backs (supine) and on their stomachs (prone) to determine which position is most beneficial.23467

Who Is on the Research Team?

KG

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Prone positioningExperimental Treatment1 Intervention
Group II: Supine positioningActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

Citations

Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) ...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 ...
Non-invasive neurally adjusted ventilatory assist in preterm ...Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is a safe, feasible and effective way to support respiration in preterm infants. • Intact neural ...
Non-Invasive Ventilation with Neurally Adjusted Ventilatory ...Conclusions: This study found similar extubation failure rates among ELBW infants as in prior studies. However, the NAVA group had lower rates ...
Non‐invasive neurally adjusted ventilatory assist (NIV‐ ...NIV-NAVA has been proposed to provide better outcomes in pre-term infants by improving patient–ventilator synchrony, measuring respiratory work, ...
NIV-NAVA versus NCPAP immediately after birth in ...Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) applied immediately after birth did not reduce work of breathing in premature infants compared to ...
Optimizing synchronized non-invasive support: Clinical ...NIV-NAVA improved synchronization in extremely premature infants compared to synchronized intermittent ventilation.15 A crossover randomized trial in preterm ...
Feasibility and physiological effects of noninvasive neurally ...NAVA assists the patient in proportion to the respiratory effort based on the detection of the electrical activity of the diaphragm (Edi) by an ...
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