NCT06263127

Sensory Motor Interventions on Preterm Infants

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 34 Weeks
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-02-20
• Primary completion: 2026-01-10
• Completion: 2026-01-10
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

1 site across 1 country: Taiwan