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| Name | Class |
|---|---|
| Shanghai Conservatory of Music | UNKNOWN |
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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.
Music therapy is an emerging interdisciplinary field that integrates musicology, medicine, and psychology. With its core advantages of being painless and non-invasive, it has shown high acceptance and safety in fields such as pediatric medicine and child healthcare, and is widely used in interventions for chronic diseases and the care of children with special needs. Its core mechanism is based on the physical resonance properties of music: as sound waves of specific frequencies, music can resonate with the body's inherent physiological rhythms (such as heart rate, breathing, and blood pressure), coordinating organ functions and regulating neural excitation or inhibition to achieve therapeutic effects for both body and mind. For infants, especially premature babies, hearing is their primary channel for perceiving the world. Fetuses can already perceive rhythmic sounds such as the mother's heartbeat during the prenatal period. By 30-35 weeks' gestation, the hearing of all infants including premature infants is relatively mature, allowing them to distinguish different sounds and respond to rhythm and melody. The stable auditory environment in the womb [such as the mother's heart rate of 60-100 beats per minute (beats/min) and the fetus's own heart rate of 110-160 beats/min] forms the foundation of early auditory experiences, and appropriate musical stimulation can continue this sense of rhythm, providing crucial support for neural development.
Over the past 20 years, the application of music therapy in neonatal intensive care units (NICUs) has received widespread attention. Research has confirmed that music interventions can effectively alleviate anxiety in preterm infants, reduce heart rate and respiratory rate, improve blood oxygen saturation, increase feeding intake, shorten feeding time, and even have positive effects on cognitive and psychological development. Relevant clinical guidelines in the United States clearly recommend that music for preterm infants should be soothing and harmonious, with a steady rhythm and no sudden jumps in notes (such as lullabies sung by a female voice , piano, or guitar pieces). However, existing studies still have significant limitations: first, most research focuses on the overall effects of music interventions without exploring the independent effects of core musical elements (such as tempo, pitch, and timbre); second, there is currently no systematic research on the specific effects of music tempo on the physiological rhythms and feeding functions of preterm infants. There is a lack of comparative analyses of music at different tempos (fast, medium, slow), which prevents precise intervention parameters from being provided for clinical practice.
Addressing the research gaps, this study will focus on the effects of music therapy at different tempos on the feeding efficiency of preterm infants, with the goal of promoting their growth and development. Through a prospective randomized open-label controlled trial, it will primarily examine the differences in feeding outcomes for preterm infants exposed to music of medium tempo (60-100 beats/min, simulating maternal heart rate), fast tempo (110-160 beats/min, simulating fetal heart rate), and slow tempo (40-50 beats/min), tracking the time to achieve full enteral feeding, and providing empirical evidence for the optimal clinical selection of music therapy.
The study has two major innovations: first, it will focus on the underexplored variable of "tempo," systematically comparing for the first time the intervention effects of music at different tempos (fast, medium, slow), thereby filling the gap in current research on targeted studies of core music parameters. Second, by presenting rhythmic music at standardized tempos (such as structured melodies simulating maternal and fetal heart rates) that can precisely match the physiological rhythm perception needs of preterm infants, the intervention's specificity and reproducibility will be enhanced. This design not only addresses the issue of ambiguous parameters in previous studies but also ensures the reliability of the results through a standardized approach, providing both theoretical and practical references for the clinical standardization of music therapy for preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical growth rate | Physical growth rate will be measured through head circumference and weight growth rate per week. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjun Zhang, Dr | Contact | 8625078999 | zhangyongjun@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongjun Zhang, Dr | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Gastrointestinal conditions will be measured through 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 | Gastrointestinal conditions will be measured through gastrointestinal function indicators: gastrin-17, pepsinogen I and pepsinogen II. | 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 | Gastrointestinal conditions will be measured through nutritional indicators: calcium and phosphorus, alkaline phosphatase. | 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 | Gastrointestinal conditions will be measured through liver and kidney function: alanine transaminase, and urea nitrogen. | 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. Sucking ability score | Gastrointestinal conditions will be measured through sucking ability score of premature infants. | 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. |
| Nervous system development assessment: 1. The Test of Infant Motor Performance. | The Test of Infant Motor Performance (TIMP) is composed of a scoring system for performance in 42 postures and movements in infants of corrected gestational age from 34 weeks to 4 months. | From correct gestational age from 34 weeks to 4 months. |
| Nervous system development assessment: 2. The Bayley III Infant Development Scale. | The Bayley III Infant Development Scale is used for the assessment of infants and young children and consists of three parts: a functional scale, an exercise scale, and a social behavior record scale, for children of corrected age up to 18 months. | From correct gestational age from 34 weeks to 18 months. |
| Nervous system development assessment: 3. Resting fMRI | An MRI scan of subjects in the state of no specific task and without systematic thinking will be used to explore changes in internal activity of the brain, using amplitude of low frequency fluctuation (ALFF), regional homogeneity (ReHo), brain functional connections, other techniques to conduct in-depth comparative studies of brain function. | Corrected age at 18 months. |
| Other: 1. Length of hospitalization | Length of hospitalization will be recorded. | 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: 2. Discharge weight | Discharge weight will be measured. | 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: 3. Amino acids | Amino acids such as lysine will be tested as exploratory indicators to assess development. | 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. |
| D000091642 | Urogenital Diseases |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |