Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03755999
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2018-08-22
Brief Title:
A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period - Explore Clinical Facts Evaluate Intervention Effects and Develop Clinical Guideline
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ENROLLING_BY_INVITATION
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:
The coordination of sucking swallowing and breathing during the transition from gavage to oral feeding is a challenge for preterm infants Efficient management of the feeding transition without other comorbidities can not only improve their oral movements and gastrointestinal function development facilitate their oral feeding learning behavior but also facilitate them to direct breastfeeding improve mother-infant attachment and ultimately reduce the length of hospitalization However the current status of strategies in supporting preterm infants throughout their feeding transition are inconsistent and lack of guidelines and monitor indicators based on existing evidence
This project proposed a three-year plan the explore the current situation examine effective strategies for care bundles and further develop a new clinical guideline that can be implemented in the future The first year of this research will use chart review among two neonatal intensive care units of Medical Center from Taipei and Tainan A semi-structured interview and questionnaire DSCS-N will be used to explore nurses knowledge attitude and skills of developmental care and the experience of caring for preterm infants during feeding transition in the neonatal intensive care units In addition gestational age body weight gavage and oral feeding amount and special events happened during feeding will be recorded and analyzed
The second year an experimental with a stratified random assignment and repeated measure design will be used with feeding transition care bundles 120 preterm infants will be recruited and assigned to experimental or control group The subjects will be fed by the routine care approach or by the feeding transition approach in one neonatal intensive care unit Intervention components include oral stimulation and cue-based feeding during the transition to oral feeding Study measures will include physical indicators POFRAS and EFS during feeding to evaluate the implementation and guide further development of the clinical guideline
The third year of guideline development will follow Bowker and the National Health Insurance Bureau which including 5 stage The results of this guideline can offer better recommendations to support preterm infants oral development provide cue-based feeding and help them succeed in the transition to oral nutrition
This project proposed a three-year plan the explore the current situation examine effective strategies for care bundles and further develop a new clinical guideline that can be implemented in the future The first year of this research will use chart review among two neonatal intensive care units of Medical Center from Taipei and Tainan A semi-structured interview and questionnaire DSCS-N will be used to explore nurses knowledge attitude and skills of developmental care and the experience of caring for preterm infants during feeding transition in the neonatal intensive care units In addition gestational age body weight gavage and oral feeding amount and special events happened during feeding will be recorded and analyzed
The second year an experimental with a stratified random assignment and repeated measure design will be used with feeding transition care bundles 120 preterm infants will be recruited and assigned to experimental or control group The subjects will be fed by the routine care approach or by the feeding transition approach in one neonatal intensive care unit Intervention components include oral stimulation and cue-based feeding during the transition to oral feeding Study measures will include physical indicators POFRAS and EFS during feeding to evaluate the implementation and guide further development of the clinical guideline
The third year of guideline development will follow Bowker and the National Health Insurance Bureau which including 5 stage The results of this guideline can offer better recommendations to support preterm infants oral development provide cue-based feeding and help them succeed in the transition to oral nutrition
Detailed Description:
None
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