Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants

NCT07506811 | Not Yet Recruiting DMC

• 1 other identifier: XH-23-085
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

Background Newborns perceive the world through sound, and music therapy in the neonatal intensive care unit has been shown to have significant benefits in terms of heart rate, oxygen saturation, sucking/feeding capacity, and length of hospital stay. However, it is still unclear what kind of music therapy can better promote early extrauterine growth in preterm infants, and further exploration and practice are needed. Music therapy is an emerging interdisciplinary discipline that integrates musicology, medicine, and psychology. In the uterine environment, the most important rhythmic sounds that the fetus can hear is the mother's heartbeat, as well as the fetus's own heartbeat. The maternal heart rate ranges from 60 to 100 beats/min, and the corresponding speed of 60-100 beats/min in music is medium speed. The fetal heart rate is 110-160 beats/min, and the corresponding speed of 110-160 beats/min in music is considered fast. Music slower than 40-50 beats/min is slow. The primary objective of this study is to investigate the effect of music therapy at different music speeds in preterm infants, at the time to full enteral feeding. Methods This is a single-center, randomized, open-label, parallel-controlled trial including 284 preterm newborns with gestational age or corrected gestational age ≥32 weeks admitted into the neonatal intensive care unit. The infants will be randomly allocated to receive music I, II, III or control therapy. The music therapy is provided with the same music in three different tempos: 40-50 beats/min, 60-100 beats/min, and 110-160 beats/min, by two professional licensed music therapists using the same instrument and singing, before morning and afternoon feeding time every day during hospitalization. The primary outcome is the time to achieving full enteral feeding. The secondary outcomes include sucking/feeding capacity, physical growth rate, complications, length of hospital stay, behavior state (Test of Infant Motor Performance (TIMP), Bayley III Infant Development Scale), and brain imaging (resting functional magnetic resonance imaging). Hypothesis: The investigator expect that either music therapy applied at 40-50 beats/min or 110-160 beats/min will result in early full enteral feeding, and reductions in length of hospital stay and complications in preterm infants.

Conditions

Music

Keywords

preterm infant; feeding; Music therapy; music speed

Outcome Measures

Primary Outcomes (1)

• Whole enteral feeding age

  Whole enteral feeding age will be measured as age at full enteral feeding, which is 150 ml/(kg·d) enteral feeding.

  From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

Secondary Outcomes (12)

• Physical growth rate

  From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

• Gastrointestinal condition: 1. Daily feeding amount

  From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

• Gastrointestinal condition: 2. Gastrointestinal function indicators

  From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

• Gastrointestinal condition: 3. Calcium and phosphorus metabolism

  From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

• Gastrointestinal condition: 4. Liver and kidney function

  From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.

Study Arms (4)

control group

NO INTERVENTION

Control group will receive no music therapy intervention outside of routine daily care.

Music therapy group I

EXPERIMENTAL

Music therapy group I will receive music at a speed of 40-50 beats/min. Each music therapy group will receive therapy in the form of the same set of four music suites in the same melodic style and rhythm.

Behavioral: Music Therapy

Music Therapy Group II

EXPERIMENTAL

Music therapy group II will receive music at 60-100 beat/min. Each music therapy group will receive therapy in the form of the same set of four music suites in the same melodic style and rhythm.

Behavioral: Music Therapy

Music Therapy Group III

EXPERIMENTAL

Music therapy group III will receive music at 110-160 beats/min. Each music therapy group will receive therapy in the form of the same set of four music suites in the same melodic style and rhythm.

Behavioral: Music Therapy

Interventions

Music Therapy BEHAVIORAL

The intervention will be conducted while the infants are hospitalized, 30 minutes before morning and afternoon feeds. The intervention sessions will last for 20 minutes per session. During the treatment, the same therapist, in the same order, and with the same instrument, will in turn play the four repertoires to each of the three intervention groups.

Music Therapy Group II; Music Therapy Group III; Music therapy group I

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants of gestational age ≥32 weeks or corrected gestational age ≥32 weeks
• Admitted to hospital within 24 hours after birth
• Apgar score ≥8 points
• Normal auditory function according to examination of brainstem auditory evoked potential

You may not qualify if:

• Congenital system defects including congenital heart disease, nervous system malformations, diaphragmatic hernias, gastrointestinal malformations
• Serious complications, such as intracranial hemorrhage, respiratory failure, or serious infection, and those requiring mechanical ventilation

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Conservatory of Music: collaborator

Study Sites (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yongjun Zhang, Dr

  Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongjun Zhang, Dr

CONTACT

8625078999; zhangyongjun@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 2, 2026
• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)