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Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants

ConditionMusic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-37
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

284 Participants
are divided into 4 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: Music therapy group IExperimental treatment 1 intervention
Group C: Music Therapy Group IIExperimental treatment 1 intervention
Group D: Music Therapy Group IIIExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

1

Physical growth rate

Physical growth rate will be measured through head circumference and weight growth rate per week.

Time frame
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.
2

Gastrointestinal condition: 1. Daily feeding amount

Gastrointestinal conditions will be measured through daily feeding amount.

Time frame
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.
3

Gastrointestinal condition: 2. Gastrointestinal function indicators

Gastrointestinal conditions will be measured through gastrointestinal function indicators: gastrin-17, pepsinogen I and pepsinogen II.

Time frame
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.
4

Gastrointestinal condition: 3. Calcium and phosphorus metabolism

Gastrointestinal conditions will be measured through nutritional indicators: calcium and phosphorus, alkaline phosphatase.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Conservatory of Music

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: