Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-11 @ 5:25 PM
Study NCT ID:
NCT06177951
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-19
First Post:
2023-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using NICU Discharge Education Tools to Enhance Discharge Preparation for Parents of Moderate to Late Preterm Infants
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
Improving the Transition to Home for Moderate to Late Preterm Infants Admitted to the NICU Through Parent Education and Discharge Preparation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to improve the transition to home for preterm infants born between 33-36 weeks gestational age and discharged from the neonatal intensive care unit (NICU) through the use of two interventions, a "NICU Discharge Passport" and "NICU Infant Care Class," for parents.
The main question\[s\] the clinical trial aims to answer are the impact of the above discharge interventions on:
* parental readiness for discharge
* feasibility of compliance with discharge instructions
* number of ER/urgent visits and hospital re-admission rates 1-month post-discharge
Participants will include parents/guardians and nurses of eligible preterm infants discharged from the Cohen Children's Medical Center NICU. Baseline data will be collected for a period of 4-6 months for a control group (who will receive current NICU discharge practices), after which two interventions will be implemented for a period of 4-6 months to the intervention groups. Interventions will include: a) NICU Discharge Passport and b) NICU Infant Care Class.
Data collection will include pre and post-discharge surveys for parent and nurse participants in charge of discharging the eligible infant participant. Surveys will assess parental readiness for discharge, compliance with discharge instructions, ER/urgent visits post-discharge, hospital re-admission rates post-discharge, and if applicable, obtain feedback on interventions.
Researchers will compare responses between control and intervention groups to understand the impact of the interventions on parental discharge preparedness.
The main question\[s\] the clinical trial aims to answer are the impact of the above discharge interventions on:
* parental readiness for discharge
* feasibility of compliance with discharge instructions
* number of ER/urgent visits and hospital re-admission rates 1-month post-discharge
Participants will include parents/guardians and nurses of eligible preterm infants discharged from the Cohen Children's Medical Center NICU. Baseline data will be collected for a period of 4-6 months for a control group (who will receive current NICU discharge practices), after which two interventions will be implemented for a period of 4-6 months to the intervention groups. Interventions will include: a) NICU Discharge Passport and b) NICU Infant Care Class.
Data collection will include pre and post-discharge surveys for parent and nurse participants in charge of discharging the eligible infant participant. Surveys will assess parental readiness for discharge, compliance with discharge instructions, ER/urgent visits post-discharge, hospital re-admission rates post-discharge, and if applicable, obtain feedback on interventions.
Researchers will compare responses between control and intervention groups to understand the impact of the interventions on parental discharge preparedness.
Detailed Description:
Currently, parents of 33-36 weeks gestational age neonates discharged from the NICU receive discharge-related information, including feeding plan, medications, follow up appointments, and more, from their discharge summary completed in the electronic medical record. This moderate to late preterm population is a unique transitory preterm population in the NICU because while these infants do not face the same risk of medical complications as their younger counterparts, they do require more focused management for very specific risks of prematurity, including poor oromotor skills, glycemic control, thermoregulation, and immature development. Furthermore, much of their short admission period in the NICU is spent in both the management of these concerns and the provision of parental education and support for the same.
The objective of this study is to improve the transition to home for 33-36 weeks gestational age preterm infants discharged from the NICU through the use of a specific "NICU Discharge Passport" and "NICU Infant Care Class" for parents. The study hypothesis is that these interventions will improve parental discharge preparedness.
Study participants will include parents/guardians and nurses of eligible preterm infants discharged from the Cohen Children's Medical Center NICU. Baseline data will be collected for a period of 4-6 months for a control group (who will receive current NICU discharge practices), after which two interventions will be implemented for a period of 4-6 months to the intervention groups. Interventions will include: a) NICU Discharge Passport, consisting of a discharge checklist and key anticipatory guidance for newborns and b) NICU Infant Care Class, provided in person weekly to all eligible study participants.
Data collection will include surveys for parents and nurses. Parents will complete a total of 2 surveys (one before discharge from the hospital, the second at a 1-month follow up survey via telephone). Nurses will complete 1 survey before discharge of the infant participant from the NICU. Survey details: The pre-discharge survey will be administered to both parents and nurses, and assess parental readiness for discharge home with their child. In addition, for parents receiving the interventions, the pre-discharge survey will obtain feedback regarding the interventions. The pre-discharge survey will be completed within the 5-day period leading up to discharge once the infant is identified by the medical team as a discharge candidate. One month post discharge from the hospital, a follow up phone call survey will be obtained from all parents participating in the study. The post-discharge survey will again assess parental readiness for discharge home with their child. It will also collect information on parental self-report on the transition home from the NICU, including any barriers encountered. Researchers will compare survey responses between control and intervention groups.
The objective of this study is to improve the transition to home for 33-36 weeks gestational age preterm infants discharged from the NICU through the use of a specific "NICU Discharge Passport" and "NICU Infant Care Class" for parents. The study hypothesis is that these interventions will improve parental discharge preparedness.
Study participants will include parents/guardians and nurses of eligible preterm infants discharged from the Cohen Children's Medical Center NICU. Baseline data will be collected for a period of 4-6 months for a control group (who will receive current NICU discharge practices), after which two interventions will be implemented for a period of 4-6 months to the intervention groups. Interventions will include: a) NICU Discharge Passport, consisting of a discharge checklist and key anticipatory guidance for newborns and b) NICU Infant Care Class, provided in person weekly to all eligible study participants.
Data collection will include surveys for parents and nurses. Parents will complete a total of 2 surveys (one before discharge from the hospital, the second at a 1-month follow up survey via telephone). Nurses will complete 1 survey before discharge of the infant participant from the NICU. Survey details: The pre-discharge survey will be administered to both parents and nurses, and assess parental readiness for discharge home with their child. In addition, for parents receiving the interventions, the pre-discharge survey will obtain feedback regarding the interventions. The pre-discharge survey will be completed within the 5-day period leading up to discharge once the infant is identified by the medical team as a discharge candidate. One month post discharge from the hospital, a follow up phone call survey will be obtained from all parents participating in the study. The post-discharge survey will again assess parental readiness for discharge home with their child. It will also collect information on parental self-report on the transition home from the NICU, including any barriers encountered. Researchers will compare survey responses between control and intervention groups.
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?: