Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants

Starting soon · Not applicable

Conditions studied: Music

In brief

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.

Key facts

Study ID

NCT07506811

Run by

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

People needed

284

Starts

2026-09-20

Expected to finish

2029-07-31

Last updated by the study team

2026-04-02

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.