Preterm InfantsNCT06263127
Sensory Motor Interventions on Preterm Infants
A study testing oral stimulation and infants massage in people with Preterm Infants, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. Read more about this study
- Who is it for?
- Ages Up to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants
- What is being tested?
- oral stimulation and infants massage
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2024to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- < 34 weeks' gestational age
- 34~40 weeks' postmenstrual age at enrollment
- 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
- weaning the ventilator and maintaining stable physiological status
Who cannot join
- Congenital anomalies
- Confirmed or suspected chromosomal or genetic abnormalities
- Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital
Taichung, 404
Yu-Rou Chiang, Bachelor, 0910-897-089, y198473@gmail.com
Pei-Yu Yang, Master, 0975-681-610, Yangpy888@gmail.com
About this study
Official title: The Effectiveness of Prefeeding Oral Stimulation and Infant Massage on Preterm Infants in the Neonatal Care Unit
Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.
Read the detailed description
Currently, two rehabilitation approaches, Prefeeding oral stimulation (OS) and infant massage (IM), are often used by health professionals to facilitate preterm infants' oral feeding abilities. The purpose of this study is to compare the effectiveness of prefeeding OS and the combined approach of prefeeding OS and IM in improving feeding performance and development of preterm infants. Participants will randomly allocated to two groups and receive either OS or combined OS plus IM. Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes. IM is a 15-minute intervention, including 5-min manual massage on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min passive exercise of moving the infant's arms and legs once. The OS group will receive OS twice a day for 10 days. The combined group will receive OS once and IM once a day for 10 days.
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
- Preterm Infants
- Being tested
- oral stimulation, infants massage
- Keywords
- NICU, Massage, Preterm infants, oral stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral stimulationBehavioural
Also called oral sensoriomotor 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 massageBehavioural
Also called body 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.
| Study group | Role | What they receive |
|---|---|---|
| OS group | Experimental | The participants receive the prefeeding oral stimulation intervention twice a day,10 days. Receives: Behavioral: oral stimulation |
| OS+ IM group | Experimental | The participants receive both prefeeding oral stimulation and infant massage once a day, in random order, 10 days. Receives: Behavioral: oral stimulation; Behavioral: infants massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral intake
The volume of oral intake in the feeding
Measured: the 1st, 8th, and 14th day of the intervention period
Transition time of oral feeding
the number of days from the first day of the intervention to the day at full oral feeding
Measured: from the date of the first day of the intervention until the date of full oral feeding, assesed up to 4 weeks
Secondary outcomes (5)
weight gain
weight gain from the first day to the last day of the intervention period
Measured: 14 days
Hospital stay
the number of days from the first day of the intervention to the day of discharge
Measured: from the date of the first day of the intervention until the date of hospital discharge, assessed up to 6 weeks
Neonatal Neurobehavioral Examination-Chinese Version(NNE-C)
It consists of three subtests: (1) Muscle Tone and Movement Patterns (12-36 points), (2) Primitive Reflexes (13-39 points), and (3) Behavioral Responses (12-36 points). A higher score means more mature motor pattern.
Measured: the 1st and 14th day of the intervention period
Infant/Toddler Sensory Profile-Chinese Version(ITSP-C)
A self-reported questionnaire completed by the primary caregiver will be used to assess sensory processing of infants from birth to three years old. It consists of 5 subscales: General Perception, Auditory Processing, Visual Processing, Tactile Processing, and Vestibular Processing. The items of the five subscales can be classified into 4 quadrants: Low registration (13-65 points), sensory seeking (6-30 points), sensation sensitivity (12-60 points), and sensory avoiding (5-25 points). A lower score means a stronger sensory quadrant pattern.
Measured: conducted at around 3 months of corrected age
Premature Bottle Feeding Questionnaire(PBFQ)
A self-reported questionnaire consists of 15-item feeding problematic behaviors. The primary caregiver will fill out each question using a 4-point scale according to the infant's feeding performance at home. The feeding score is from 15 to 60 points. A higher score means poorer feeding performance.
Measured: conducted at around 3 months old of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263127
- Sponsor's protocol ID
- CMUH112-REC2-104
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2024
- Last updated
- 16 Feb 2024
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Prefeeding Oral Stimulation and Infant Massage on Preterm Infants in the Neonatal Care Unit
- ClinicalTrials.gov ID
- NCT06263127
- Acronym / sponsor ID
- CMUH112-REC2-104
- Conditions
- Preterm Infants
- Keywords
- NICU, Massage, Preterm infants, oral stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 16 Feb 2024 (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.
Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.
Detailed description
Currently, two rehabilitation approaches, Prefeeding oral stimulation (OS) and infant massage (IM), are often used by health professionals to facilitate preterm infants' oral feeding abilities. The purpose of this study is to compare the effectiveness of prefeeding OS and the combined approach of prefeeding OS and IM in improving feeding performance and development of preterm infants. Participants will randomly allocated to two groups and receive either OS or combined OS plus IM. Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes. IM is a 15-minute intervention, including 5-min manual massage on the infant's head, neck, back, upper limbs, and lower limbs twice and 5-min passive exercise of moving the infant's arms and legs once. The OS group will receive OS twice a day for 10 days. The combined group will receive OS once and IM once a day for 10 days.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OS group | Experimental | Behavioral: oral stimulationThe participants receive the prefeeding oral stimulation intervention twice a day,10 days. |
| OS+ IM group | Experimental | Behavioral: oral stimulation, Behavioral: infants massageThe participants receive both prefeeding oral stimulation and infant massage once a day, in random order, 10 days. |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- < 34 weeks' gestational age
- 34~40 weeks' postmenstrual age at enrollment
- 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
- weaning the ventilator and maintaining stable physiological status
Key exclusion criteria (3 listed)
- Congenital anomalies
- Confirmed or suspected chromosomal or genetic abnormalities
- Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)
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 |
|---|---|---|
| oral stimulationAlso: oral sensoriomotor stimulationPrefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes. | Behavioural | OS group, OS+ IM group |
| infants massageAlso: body massageIM 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. | Behavioural | OS+ IM group |
Primary outcome
Oral intake
Time frame: the 1st, 8th, and 14th day of the intervention period
The volume of oral intake in the feeding
Transition time of oral feeding
Time frame: from the date of the first day of the intervention until the date of full oral feeding, assesed up to 4 weeks
the number of days from the first day of the intervention to the day at full oral feeding
5 secondary outcomes
weight gain
Time frame: 14 days
Hospital stay
Time frame: from the date of the first day of the intervention until the date of hospital discharge, assessed up to 6 weeks
Neonatal Neurobehavioral Examination-Chinese Version(NNE-C)
Time frame: the 1st and 14th day of the intervention period
Infant/Toddler Sensory Profile-Chinese Version(ITSP-C)
Time frame: conducted at around 3 months of corrected age
Premature Bottle Feeding Questionnaire(PBFQ)
Time frame: conducted at around 3 months old of corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral stimulation and infants massage in people with Preterm Infants, run by China Medical University Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral intake (time frame: the 1st, 8th, and 14th day of the intervention period). The study lists 2 primary outcomes in all. 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 16 Feb 2024.