Sensory Motor Interventions on Preterm Infants

February 14, 2024 updated by: China Medical University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pei-Yu Yang, Master
        • Sub-Investigator:
          • Yea-Shwu Hwang, ScD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. < 34 weeks' gestational age
  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:

  1. Congenital anomalies
  2. Confirmed or suspected chromosomal or genetic abnormalities
  3. Unsolved seizure, sepsis, necrotizing enterocolitis(NEC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OS group
The participants receive the prefeeding oral stimulation intervention twice a day,10 days.
Behavioral: 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.
Other Names:
  • oral sensoriomotor stimulation
Experimental: OS+ IM group
The participants receive both prefeeding oral stimulation and infant massage once a day, in random order, 10 days.
Behavioral: 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.
Other Names:
  • oral sensoriomotor stimulation
Behavioral: 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 Names:
  • body massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral intake
Time Frame: the 1st, 8th, and 14th day of the intervention period
The volume of oral intake in the feeding
the 1st, 8th, and 14th day of the intervention period
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
from the date of the first day of the intervention until the date of full oral feeding, assesed up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight gain
Time Frame: 14 days
weight gain from the first day to the last day of the intervention period
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
the number of days from the first day of the intervention to the day of discharge
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
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.
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
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.
conducted at around 3 months of corrected age
Premature Bottle Feeding Questionnaire(PBFQ)
Time Frame: conducted at around 3 months old of corrected age
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.
conducted at around 3 months old of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2024

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

January 10, 2026

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC2-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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