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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)

Must not have

Infants diagnosed with surgical necrotizing enterocolitis

Infants who are diagnosed with congenital malformations of bowel or bowel perforations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-8 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My baby was born before reaching 33 weeks of pregnancy.

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I need breathing support that stops me from eating by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has been diagnosed with a severe intestinal condition requiring surgery.

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My infant has a diagnosed bowel issue from birth.

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I need a machine to help me breathe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oral Feeding

Secondary study objectives

Length of Respiratory Support

Length of Stay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met