Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-02-20
2026-01-10
Brief Summary
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Detailed Description
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Both groups will undergo a bottle feeding assessment before, mid-term, and after the intervention period. Neurodevelopmental assessments will be conducted before and after the intervention period. Additionally, the investigator will conduct chart review to collect participants' birth and medical data. The primary outcomes are feeding performance parameters (e.g., the rate of milk transfer in the first 5 minutes of feeding, total oral intake volume, and milk leakage during bottle feeding) and neurodevelopment outcomes. Secondary outcomes include weight gain and hospital stay. Furthermore, a follow-up evaluation on feeding questionnaire at home and sensory processing function will be conducted when the infants reach three months of corrected age.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OS group
The participants receive the prefeeding oral stimulation intervention twice a day,10 days.
oral stimulation
Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes.
OS+ IM group
The participants receive both prefeeding oral stimulation and infant massage once a day, in random order, 10 days.
oral stimulation
Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes.
infants massage
IM is a 15-minute intervention, involving 5-min manual stroking on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min gentle flexion and extension exercises on the infant's arms and legs.
Interventions
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oral stimulation
Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes.
infants massage
IM is a 15-minute intervention, involving 5-min manual stroking on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min gentle flexion and extension exercises on the infant's arms and legs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 34\~40 weeks' postmenstrual age at enrollment
3. being fed by oral for at least 2 days but with poor feeding performance defined as consuming less than 80% of the prescribed volume for the half or more feedings
4. weaning the ventilator and maintaining stable physiological status
Exclusion Criteria
2. Confirmed or suspected chromosomal or genetic abnormalities
3. Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)
34 Weeks
ALL
Yes
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Facility Contacts
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Other Identifiers
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CMUH112-REC2-104
Identifier Type: -
Identifier Source: org_study_id
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