PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

NCT05446389 | Terminated FDA Device

• 1 other identifier: 2091032
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of the Pacifier Activated Lullaby (PAL) intervention on the transition to oral feeding for preterm infants with chronic lung disease and respiratory distress syndrome that require non-invasive respiratory support at 34 weeks PMA. This study will utilize a clinical trial design. Participants will be randomized into two groups. One group will receive the PAL intervention, the other group serving as a no contact control. Participants will be matched based on sex, gestational age at birth, and neurologic injury. Infants in the intervention group will receive two PAL sessions a week until successfully transitioned to \<2L of respiratory support and then receive one PAL session within 24 hours of their first oral feeding attempt.

Conditions

Bronchopulmonary Dysplasia; Preterm Birth; Chronic Lung Disease of Prematurity; Respiratory Distress Syndrome in Premature Infant

Keywords

Music Therapy; NICU; Pacifier Activated Lullaby; Premature Infant; Chronic Lung Disease; Oral Feeding

Outcome Measures

Primary Outcomes (1)

• Oral Feeding

  Time to full transition from gavage to oral feeding by mouth as measured by days

  1-6 weeks

Secondary Outcomes (2)

• Length of Stay

  1-8 months

• Length of Respiratory Support

  1-16 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Device: Pacifier Activated Lullaby ®

Control Group

NO INTERVENTION

Infants randomized in to the control group will not receive music therapy intervention throughout NICU admission.

Interventions

Pacifier Activated Lullaby ® DEVICE

Pacifier Activated Lullaby (PAL®) is a medical device that encourages and reinforces the development of non-nutritive sucking (NNS) of premature infants. This is accomplished by giving positive feedback in the form of music/mother's voice as an auditory input in direct response to effective sucking.

Intervention Group

Eligibility Criteria

• Age: 1 Day - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All infants born less than 33 weeks PMA
• Infants enrolled prior to 35 weeks PMA
• Medically stable to tolerate minimal levels of auditory stimulation
• Approval from medical staff to begin intervention
• 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)

You may not qualify if:

• Infants participating in other music therapy studies.
• Infants in custody of Children's Division
• Requiring non-invasive respiratory support that does not inhibit the start of oral feeding, including High Flow Nasal Cannula (≤ 2L), Nasal Cannula
• Requiring no respiratory support
• Requiring invasive respiratory support
• Infants who are diagnosed with congenital malformations of bowel or bowel perforations
• Infants diagnosed with surgical necrotizing enterocolitis

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of Georgia: collaborator

Study Sites (1)

University of Missouri Healthcare

Columbia, Missouri, 65212, United States

Location

Related Publications (6)

• Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N. The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.

  PMID: 32086439 BACKGROUND

• Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.

  PMID: 24534413 BACKGROUND

• Glackin SJ, O'Sullivan A, George S, Semberova J, Miletin J. High flow nasal cannula versus NCPAP, duration to full oral feeds in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F329-F332. doi: 10.1136/archdischild-2016-311388. Epub 2016 Dec 23.

  PMID: 28011792 BACKGROUND

• Hanin M, Nuthakki S, Malkar MB, Jadcherla SR. Safety and Efficacy of Oral Feeding in Infants with BPD on Nasal CPAP. Dysphagia. 2015 Apr;30(2):121-7. doi: 10.1007/s00455-014-9586-x. Epub 2014 Nov 8.

  PMID: 25380678 BACKGROUND

• Hatch LD 3rd, Clark RH, Carlo WA, Stark AR, Ely EW, Patrick SW. Changes in Use of Respiratory Support for Preterm Infants in the US, 2008-2018. JAMA Pediatr. 2021 Oct 1;175(10):1017-1024. doi: 10.1001/jamapediatrics.2021.1921.

  PMID: 34228110 BACKGROUND

• Jain D, Bancalari E. New Developments in Respiratory Support for Preterm Infants. Am J Perinatol. 2019 Jul;36(S 02):S13-S17. doi: 10.1055/s-0039-1691817. Epub 2019 Jun 25.

  PMID: 31238352 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only one person (the primary investigator, who will be implementing the intervention) will be unmasked for this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will utilize a clinical trial design. Participants will be randomized into two groups. One group will receive the PAL intervention, the other group serving as a no contact control. Participants will be matched based on sex, gestational age at birth, and neurologic injury. Infants in the intervention group will receive two PAL sessions a week until successfully transitioned to \<2L of respiratory support and then receive one PAL session within 24 hours of their first oral feeding attempt.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: June 8, 2022
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)