PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Other music therapy, Bowel malformations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Pacifier Activated Lullaby (PAL) device might assist preterm infants with chronic lung disease in starting to feed by mouth. The PAL plays music when the baby sucks on a pacifier, encouraging better sucking skills. Babies in the trial will either receive this music therapy or be in a no-contact group. Ideal candidates are infants born before 33 weeks who are stable enough to hear sounds but require breathing assistance that prevents oral feeding. As an unphased trial, this study provides a unique opportunity for infants to potentially benefit from innovative music therapy while contributing to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Pacifier Activated Lullaby (PAL) intervention is safe for infants with chronic lung disease?

Research has shown that the Pacifier Activated Lullaby (PAL) is safe for preterm babies. Studies have examined its effects and found no major safety issues. The FDA has approved the PAL device, confirming it meets safety standards for use in neonatal intensive care units (NICUs). Additionally, a similar music-playing pacifier improved feeding skills without causing stress or growth problems in babies. These findings suggest that infants generally tolerate the PAL well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pacifier Activated Lullaby (PAL) intervention because it offers a unique approach to improving oral feeding in infants with chronic lung disease. Unlike traditional methods, which may rely on gradually introducing oral feeds or using different feeding techniques, PAL uses music as positive reinforcement. This innovative device connects to an infant's pacifier and plays soothing music when it detects sucking, encouraging better feeding habits. This method not only aims to enhance sucking skills but also provides a comforting and engaging experience for infants, potentially leading to faster transitions to oral feeding.

What evidence suggests that the Pacifier Activated Lullaby (PAL) intervention is effective for improving oral feeding in preterm infants with chronic lung disease?

Research has shown that the Pacifier Activated Lullaby (PAL) can help preterm infants learn to feed by mouth more effectively. In this trial, infants in the experimental group will receive the PAL intervention. The device plays music when the baby sucks on a pacifier, improving their sucking skills. One study found that a similar music-playing pacifier with a mother's voice reduced the time babies needed tube feeding, without causing stress or affecting growth. These early findings suggest that PAL might improve feeding skills in infants with chronic lung disease. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Approval from medical staff to begin intervention

My baby was born before reaching 33 weeks of pregnancy.

Medically stable to tolerate minimal levels of auditory stimulation

Exclusion Criteria

My infant is not involved in other music therapy studies.

Requiring no respiratory support

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Infants in the experimental group receive the PAL intervention 2 times a week until they transition to room air or <2L high flow nasal cannula and begin oral feeding attempts.

1-6 weeks

2 sessions per week

Control

Infants in the control group do not receive any music therapy intervention throughout NICU admission.

1-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on the transition to oral feeding and respiratory support.

1-8 months

What Are the Treatments Tested in This Trial?

Interventions

• Pacifier Activated Lullaby (PAL) intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 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 Group Active Control 1 Intervention

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

Pacifier Activated Lullaby (PAL) intervention is already approved in United States for the following indications:

Approved in United States as Pacifier Activated Lullaby for:

• Improving oral feeding in preterm infants with chronic lung disease and respiratory distress syndrome

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

Published Research Related to This Trial

Premature infants who were given pacifiers transitioned to total oral feeding faster than those in the lullaby and control groups, indicating that pacifiers can significantly aid in this critical developmental stage.

The study also found that pacifiers improved sucking success in infants, suggesting that using pacifiers and lullabies can enhance feeding skills and positively impact vital signs like heart rate and oxygen saturation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of giving pacifiers to premature infants and making them listen to lullabies on their transition period for total oral feeding and sucking success. Yildiz, A., Arikan, D.[2022]

The study analyzed 62 premature infants over a 2-year period to assess the impact of Pacifier Activated Lullaby (PAL) trials on weight gain, but found no significant difference in daily weight gain based on the number of PAL trials completed.

While there were trends indicating greater weight gain associated with PAL use, individual variability was high, and the most effective timing for PAL trials appears to be 30 minutes prior to feeding, as this timing resulted in the highest average music reinforcement received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the pacifier activated lullaby on weight gain of premature infants. Cevasco, AM., Grant, RE.[2019]

Pacifier use in infants can provide several benefits, including pain relief during minor medical procedures and a reduced risk of sudden infant death syndrome (SIDS), especially when used at sleep onset for infants one month and older.

While pacifiers can be helpful, prolonged use may lead to complications such as negative effects on breastfeeding, dental issues, and otitis media, prompting recommendations to wean children from pacifiers during the second half of their first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and benefits of pacifiers. Sexton, S., Natale, R.[2022]

Oral motor interventions (OMIs), particularly nonnutritive sucking (NNS) and NNS combined with oral/perioral stimulation, showed strong positive effects on improving feeding and swallowing physiology in preterm infants, helping to reduce the time it takes for them to transition to oral feeding.

Despite some improvements in feeding physiology, none of the OMIs consistently resulted in significant weight gain or growth, highlighting the need for further research to establish their overall effectiveness and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based systematic review: effects of oral motor interventions on feeding and swallowing in preterm infants. Arvedson, J., Clark, H., Lazarus, C., et al.[2018]

Preterm infants who used pacifiers while being fed through orogastric tubes gained weight more effectively, averaging 7 grams more per day compared to those who did not use pacifiers.

The use of pacifiers also allowed these infants to start total oral feeding earlier and led to earlier discharge from the hospital, indicating potential benefits for their overall development and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effect of pacifier use on orogastric tube-fed preterm infants: A randomized controlled trial. Calik, C., Esenay, F.[2020]

In a study involving 32 premature infants, the use of music reinforcement during nonnutritive sucking significantly increased their nipple feeding rates after the intervention.

The intervention involved a 15-minute session where a pacifier activated music, helping infants transition from nonnutritive to nutritive sucking, which is crucial for their feeding development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music-reinforced nonnutritive sucking on feeding rate of premature infants. Standley, JM.[2019]

In a study of 250 healthy babies, pacifier use was linked to a higher rate of early weaning, with 50.8% of pacifier users stopping breastfeeding by six months compared to only 22.4% of non-pacifier users.

The research found that nearly two-thirds of pacifier users stopped exclusive breastfeeding before two months, highlighting a significant association between pacifier use and reduced breastfeeding duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pacifier use and its relationship with early weaning in infants born at a Child-Friendly Hospital]. Soares, ME., Giugliani, ER., Braun, ML., et al.[2020]

The study evaluated the effectiveness and safety of cue-based feeding strategies in 55 infants with bronchopulmonary dysplasia compared to a control group of 60 infants using traditional provider-driven feeding methods.

Both the Oral Feeding Readiness Scale and the Oral Feeding Quality Scale were validated, supporting the use of cue-based feeding strategies as a beneficial approach for infants with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement study of effectiveness of cue-based feeding in infants with bronchopulmonary dysplasia in the neonatal intensive care unit. Davidson, E., Hinton, D., Ryan-Wenger, N., et al.[2019]

Non-nutritive sucking (NNS) using a pacifier significantly improved oxygen saturation levels in preterm infants during and after nasogastric feeding, indicating better physiological responses.

Infants who practiced NNS transitioned to nipple feeding more quickly, gained weight better, and were discharged earlier compared to those who did not use NNS, highlighting its positive impact on behavioral outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-nutritive sucking for preterm infants in Egypt. Kamhawy, H., Holditch-Davis, D., Alsharkawy, S., et al.[2022]

In a study of 70 preterm infants, those who used pacifiers transitioned to full breastfeeding significantly faster (123 hours) compared to those who did not use pacifiers (168 hours), indicating that pacifier use can facilitate breastfeeding.

Pacifier use also improved sucking skills in preterm infants, which is crucial for their feeding development, and led to earlier hospital discharge, suggesting a practical benefit for neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial. Kaya, V., Aytekin, A.[2018]

The pacifier-activated-lullaby (PAL) system significantly reduced the length of gavage feeding for premature infants at 34 weeks adjusted gestational age, with three PAL trials being more effective than one.

Female infants learned to nipple feed faster than male infants, and while PAL infants tended to go home sooner after starting nipple feeding, this trend was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants. Standley, JM., Cassidy, J., Grant, R., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05446389

NCT05446389 | PAL to Improve Oral Feeding for Infants ... 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 ...

2. withpower.com withpower.com/trial/phase-lung-diseases-5-2022-545ed

PAL to Improve Oral Feeding for Infants With Chronic Lung ... Research shows that using pacifiers and playing lullabies can help premature infants transition to full oral feeding more successfully and improve their ...

3. ctv.veeva.com ctv.veeva.com/study/pal-to-improve-oral-feeding-for-infants-with-chronic-lung-disease

PAL to Improve Oral Feeding for Infants With Chronic Lung ... The purpose of this study is to investigate the effects of the Pacifier Activated Lullaby (PAL) intervention on the transition to oral ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3934339/

A Pacifier-Activated Music Player With Mother's Voice ... A brief intervention with a pacifier-activated music player using mother's voice can decrease tube feeding duration without adverse effects on stress or growth.

5. clinicaltrial.be clinicaltrial.be/en/details/354?only_recruiting=0&only_eligible=0

PAL to Improve Oral Feeding for Infants With Chronic Lung... When the infant is on <2L of respiratory support they will receive one more PAL session within 24 hours prior to their first oral feeding ...