Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263127
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-01-10
Brief Title:
Sensory Motor Interventions on Preterm Infants
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
The Effectiveness of Prefeeding Oral Stimulation and Infant Massage on Preterm Infants in the Neonatal Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 infants head neck back upper limbs and lower limbs twice and 5-min passive exercise of moving the infants 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None