Sensory Motor Interventions on Preterm Infants

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06263127
Study type	Interventional
Source	China Medical University Hospital
Contact
Status	Not yet recruiting
Phase	N/A
Start date	February 20, 2024
Completion date	January 10, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.