Sensory Motor Interventions on Preterm Infants

NCT06263127 | Not Yet Recruiting DMC

• 1 other identifier: CMUH112-REC2-104
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm Infants

Keywords

NICU; Massage; Preterm infants; oral stimulation

Outcome Measures

Primary Outcomes (2)

• Oral intake

  The volume of oral intake in the feeding

  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

  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

  14 days

• Hospital stay

  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)

  the 1st and 14th day of the intervention period

• Infant/Toddler Sensory Profile-Chinese Version(ITSP-C)

  conducted at around 3 months of corrected age

• Premature Bottle Feeding Questionnaire(PBFQ)

  conducted at around 3 months old of corrected age

Study Arms (2)

OS group

EXPERIMENTAL

The participants receive the prefeeding oral stimulation intervention twice a day,10 days.

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.

Behavioral: oral stimulation; Behavioral: infants massage

Interventions

oral stimulation BEHAVIORAL

Prefeeding OS is a 5-minute oral sensorimotor intervention, containing peri- and intra-oral stimulation for 3 minutes and pacifier sucking for 2 minutes.

Also known as: oral sensoriomotor stimulation

OS group; OS+ IM group

infants massage BEHAVIORAL

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.

Also known as: body massage

OS+ IM group

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \< 34 weeks' gestational age
• \~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

You may not qualify if:

• Congenital anomalies
• Confirmed or suspected chromosomal or genetic abnormalities
• Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 16, 2024
• Study Start: February 20, 2024
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)