Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613386
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Effects of an Information-Based Discharge Service on Preterm Infants Parents and Hospitals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant Parent and Hospital a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BackgroundThe Information-Based Discharge Preparation Service IBDPS supports parents of preterm infants during the transition from hospital to home but its effectiveness has not been widely studied
ObjectiveTo evaluate the impact of IBDPS on parental readiness caregiving skills stress satisfaction infant development readmission rates length of stay and hospital costs
Design A randomized controlled trial RCT in a NICU in Jiangsu Province China
Participants Preterm infants and their parents
MethodsParticipants are randomly assigned to receive either IBDPS plus usual care intervention group or usual care alone control group Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge along with hospital metrics like length of stay and readmission rates
ObjectiveTo evaluate the impact of IBDPS on parental readiness caregiving skills stress satisfaction infant development readmission rates length of stay and hospital costs
Design A randomized controlled trial RCT in a NICU in Jiangsu Province China
Participants Preterm infants and their parents
MethodsParticipants are randomly assigned to receive either IBDPS plus usual care intervention group or usual care alone control group Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge along with hospital metrics like length of stay and readmission rates
Detailed Description:
Participants are randomly allocated to the intervention and control groups The intervention group receives the IBDPS in addition to the usual care while the control group receives only the usual discharge education The IBDPS grounded in the theories of empowerment and Timing It Right TIR leverages an information-based platform to provide continuous multidimensional and customized support to parents from their infants admission to one month post-discharge ensuring seamless integration of discharge preparation both online and offline and within and outside the hospital Baseline data are collected at allocation T1 Parental outcomes including readiness for hospital discharge and stress are assessed at T1 upon NICU entry T2 and prior to discharge T3 while caregiving skills are measured at T1 T2 T3 and one month post-discharge T4 Parental satisfaction is measured at T3 Infant outcomes such as weight length head circumference breastfeeding rate and feeding intolerance rate are recorded at T1 T2 T3 and T4 with Neonatal Behavior Neurologic Assessment NBNA scores evaluated at T4 Hospital outcomes include length of stay and hospitalization costs assessed at T3 and unplanned readmissions recorded at T4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None