Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07506811
NA

Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants: a Randomized Open-label Parallel-controlled Trial Protocol

Key Details

Gender

All

Age Range

32 Weeks - 37 Weeks

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2026-09-20

Completion Date

2029-07-31

Last Updated

2026-04-02

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Music Therapy

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.

Locations (1)

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

Shanghai, Shanghai Municipality, China