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PAL to Improve Oral Feeding for Infants With Chronic Lung Disease
N/A
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All infants born less than 33 weeks PMA
Requiring non-invasive respiratory support that inhibits the start of oral feeding, including: Continuous Positive Airway Pressure (CPAP), Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA), Non-Invasive Ventilator (NIV), High Flow Nasal Cannula (>2L), and Non-invasive positive pressure ventilation (NIPPV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-8 months
Awards & highlights
Study Summary
This trial is investigating whether a Pacifier Activated Lullaby (PAL) can help preterm infants with chronic lung disease and respiratory distress syndrome transition to oral feeding. The study will use a clinical trial design to compare an intervention group receiving the PAL to a no-contact control group.
Who is the study for?
This trial is for preterm infants with chronic lung disease and respiratory distress syndrome who need non-invasive breathing support and can handle a little bit of sound. They should be born before 33 weeks of pregnancy and enrolled before reaching 35 weeks. Babies with certain bowel issues, on invasive breathing support, in other music therapy studies, or without any respiratory support are not eligible.Check my eligibility
What is being tested?
The study tests the Pacifier Activated Lullaby (PAL) system to see if it helps premature babies with lung problems start eating by mouth sooner. Infants will be randomly placed into two groups: one receiving PAL sessions twice weekly until they need less respiratory support, then once right before their first oral feeding; the other group won't get this intervention.See study design
What are the potential side effects?
Since PAL involves auditory stimulation through a pacifier that plays lullabies when sucked correctly, potential side effects might include overstimulation or discomfort due to noise for sensitive infants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born before reaching 33 weeks of pregnancy.
Select...
I need breathing support that stops me from eating by mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oral Feeding
Secondary outcome measures
Length of Respiratory Support
Length of Stay
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Infants randomized in to the experimental group will receive the PAL intervention 2 times a week until the infant transitions to room air or < 2L high flow nasal cannula and is able to begin attempting feeds by mouth. The PAL is an FDA cleared medical device that has a sensor that will connect to the infant's pacifier and can read the infant's suck. Then, the device plays music as positive reinforcement to help improve sucking skills. This intervention typically lasts about 15 minutes and is implemented while the infant is receiving gavage feeds.
Group II: Control GroupActive Control1 Intervention
Infants randomized in to the control group will not receive music therapy intervention throughout NICU admission.
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,054 Total Patients Enrolled
University of GeorgiaOTHER
100 Previous Clinical Trials
34,598 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born before reaching 33 weeks of pregnancy.I need breathing support that stops me from eating by mouth.My infant is not involved in other music therapy studies.My infant has been diagnosed with a severe intestinal condition requiring surgery.My infant has a diagnosed bowel issue from birth.I need a machine to help me breathe.My baby was enrolled in the study before reaching 35 weeks of gestational age.I need some breathing support but can start eating by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Intervention Group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being considered for inclusion in the current medical experiment?
"This medical experiment is specifically seeking infants and toddlers between 1 day old and 33 weeks of age. For comparison, 635 clinical trials exist for those below 18 years-of-age while 1416 are available to patients above 65."
Answered by AI
Is enrollment open for this research endeavor?
"According to the details on clinicaltrials.gov, this investigation is not currently seeking applicants; though it was listed on June 8th 2022 and revised July 6th 2022. Although this trial isn't enrolling new participants at present, there are 2061 other studies that do have open enrollment slots."
Answered by AI
What type of individual is most conducive to taking part in this medical trial?
"This medical experiment calls for 60 participants that suffer from bronchopulmonary dysplasia and are between 1 Day and 33 Weeks old. Eligibility requires meeting these criteria."
Answered by AI
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