Sensory Motor Interventions on Preterm Infants

China Medical University

Status: Not yet enrolling

Conditions: Preterm Infants

Treatments: Behavioral: infants massage; Behavioral: oral stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06263127

CMUH112-REC2-104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 34 weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

OS group

Experimental group

Description:

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

Treatment:

Behavioral: oral stimulation

OS+ IM group

Experimental group

Description:

The participants receive both prefeeding oral stimulation and infant massage once a day, in random order, 10 days.

Treatment:

Behavioral: oral stimulation

Behavioral: infants massage