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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Pacifier Activated Lullaby (PAL) for improving oral feeding in infants with chronic lung disease?

Research shows that using pacifiers and playing lullabies can help premature infants transition to full oral feeding more successfully and improve their sucking ability. Additionally, non-nutritive sucking with a pacifier has been found to positively affect the health and behavior of preterm infants. ^{1 2 3 4 5}

Is the Pacifier Activated Lullaby (PAL) intervention safe for use in infants?

The Pacifier Activated Lullaby (PAL) intervention has been studied in premature infants and has not shown any significant safety concerns. Pacifier use, in general, is considered safe for infants and is associated with benefits like pain relief and reduced risk of sudden infant death syndrome, though prolonged use may affect breastfeeding and dental health. ^{2 6 7 8 9}

How is the Pacifier Activated Lullaby (PAL) treatment different from other treatments for infants with chronic lung disease?

The Pacifier Activated Lullaby (PAL) treatment is unique because it uses music to encourage non-nutritive sucking in premature infants, which helps them transition to oral feeding more quickly. This approach is different from other treatments as it combines a pacifier with music reinforcement to improve feeding skills, rather than relying solely on traditional feeding methods. ^{1 2 6 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Pacifier use and its relationship with early weaning in infants born at a Child-Friendly Hospital]. [2020]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based systematic review: effects of oral motor interventions on feeding and swallowing in preterm infants. [2018]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Non-nutritive sucking for preterm infants in Egypt. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effects of the pacifier activated lullaby on weight gain of premature infants. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Risks and benefits of pacifiers. [2022]

9. Pakistan pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

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