MusicNCT07506811
Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants
A study testing Music Therapy in people with Music, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 37 weeks
- Conditions the study is for
- Music
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Jingwen Lyu, Doctor, +86-021-25078335, jingwen_lv@163.com
About this study
Official title: Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants: a Randomized Open-label Parallel-controlled Trial Protocol
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Music
- Being tested
- Music Therapy
- Keywords
- preterm infant, feeding, Music therapy, music speed
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Secondary outcomes (12)
Physical growth rate
Physical growth rate will be measured through head circumference and weight growth rate per week.
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.
Gastrointestinal condition: 1. Daily feeding amount
Gastrointestinal conditions will be measured through daily feeding amount.
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.
Gastrointestinal condition: 2. Gastrointestinal function indicators
Gastrointestinal conditions will be measured through gastrointestinal function indicators: gastrin-17, pepsinogen I and pepsinogen II.
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.
Gastrointestinal condition: 3. Calcium and phosphorus metabolism
Gastrointestinal conditions will be measured through nutritional indicators: calcium and phosphorus, alkaline phosphatase.
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.
Gastrointestinal condition: 4. Liver and kidney function
Gastrointestinal conditions will be measured through liver and kidney function: alanine transaminase, and urea nitrogen.
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.
Gastrointestinal condition: 4. Sucking ability score
Gastrointestinal conditions will be measured through sucking ability score of premature infants.
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.
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.
Measured: 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.
Measured: 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.
Measured: Corrected age at 18 months.
Other: 1. Length of hospitalization
Length of hospitalization will be recorded.
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: 2. Discharge weight
Discharge weight will be measured.
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusicStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Conservatory of Music
- Responsible party
- Principal investigator, Yongjun Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yongjun Zhang, Dr, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506811
- Sponsor's protocol ID
- XH-23-085
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Music Tempos on Feeding Outcomes in Preterm Infants: a Randomized Open-label Parallel-controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07506811
- Acronym / sponsor ID
- XH-23-085
- Conditions
- Music
- Keywords
- preterm infant, feeding, Music therapy, music speed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Conservatory of Music
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Control group will receive no music therapy intervention outside of routine daily care. |
| Music therapy group I | Experimental | Behavioral: Music TherapyMusic 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. |
| Music Therapy Group II | Experimental | Behavioral: Music TherapyMusic 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. |
| Music Therapy Group III | Experimental | Behavioral: Music TherapyMusic 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. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyThe 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. | Behavioural | Music Therapy Group II, Music Therapy Group III, Music therapy group I |
Primary outcome
Whole enteral feeding age
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.
Whole enteral feeding age will be measured as age at full enteral feeding, which is 150 ml/(kg·d) enteral feeding.
12 secondary outcomes
Physical growth rate
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.
Gastrointestinal condition: 1. 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.
Gastrointestinal condition: 2. Gastrointestinal function indicators
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.
Gastrointestinal condition: 3. Calcium and phosphorus metabolism
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.
Gastrointestinal condition: 4. Liver and kidney function
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.
Gastrointestinal condition: 4. Sucking ability score
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.
Nervous system development assessment: 1. The Test of Infant Motor Performance.
Time frame: From correct gestational age from 34 weeks to 4 months.
Nervous system development assessment: 2. The Bayley III Infant Development Scale.
Time frame: From correct gestational age from 34 weeks to 18 months.
Nervous system development assessment: 3. Resting fMRI
Time frame: Corrected age at 18 months.
Other: 1. Length of hospitalization
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: 2. Discharge weight
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: 3. Amino acids
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongjun Zhang, Dr principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Music, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Zhang, Dr (8625078999, zhangyongjun@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole enteral feeding age (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.