Sensory Motor Interventions on Preterm Infants

Preterm Infants Clinical Trial

Official title:

The Effectiveness of Prefeeding Oral Stimulation and Infant Massage on Preterm Infants in the Neonatal Care Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263127
• Other study ID #: CMUH112-REC2-104
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: January 10, 2026

Study information

• Verified date: February 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 10, 2026
• Est. primary completion date: January 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 34 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral intake	The volume of oral intake in the feeding	the 1st, 8th, and 14th day of the intervention period
Primary	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	weight gain	weight gain from the first day to the last day of the intervention period	14 days
Secondary	Hospital stay	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
Secondary	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.	the 1st and 14th day of the intervention period
Secondary	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.	conducted at around 3 months of corrected age
Secondary	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.	conducted at around 3 months old of corrected age