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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | This group will receive neither of the interventions (NICU Discharge Passport, NICU Infant Care Class). | |
| Received NICU Discharge Passport Only | Experimental | This group will receive only one intervention: NICU Discharge Passport. |
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| Received NICU Infant Care Class Only | Experimental | This group will receive only one intervention: NICU Infant Care Class. |
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| Received Both NICU Discharge Passport and NICU Infant Care Class | Experimental | This group will receive both interventions: NICU Discharge Passport, NICU Infant Care Class. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICU Discharge Passport | Other | The NICU discharge passport contains a discharge checklist highlighting important "go-to" information for infants (feeding plan, medications, pharmacy information, pediatrician, and follow ups post-discharge). It also provides key anticipatory guidance for newborns. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Readiness for Hospital Discharge | Parental readiness for discharge will be assessed through survey questions administered to both nurse and parent participants. Parent participants will answer the questions pre-discharge and 1-month post-discharge. Nurse participants will answer the questions pre-discharge. The survey will consist of 10 questions on a Likert scale (responses are assigned numerical points which will be summed to obtain a readiness score). The questions will assess parental confidence, preparation, knowledge, and support at home in regards to discharge with their infant. | Pre-discharge, 1-month Post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ER/Urgent Visits | At follow up survey, 1-month post-discharge from the hospital, parent participants will be asked how many ER and/or urgent visits they have had since leaving the NICU. | 1-month Post-Discharge |
| Hospital Re-admission Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Sullivan, MD | ksullivan14@northwell.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cohen Children's Medical Center | Queens | New York | 11040 | United States |
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| NICU Infant Care Class | Other | The class will be provided once or twice weekly to eligible study participants. It will be conducted in a small group format. Class teachers will focus on providing key anticipatory guidance to aid in the transition home during the first month of life . Topics related to infant care will be discussed, including feeding, elimination, skincare, hygiene, soothing, development, and when to see a doctor/emergencies. |
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At follow up survey, 1-month post-discharge from the hospital, parent participants will be asked if their child has required re-admission since discharge from the NICU.
| 1-month Post-Discharge |
| Adherence to Discharge Instructions | At follow up survey, 1-month post-discharge from the hospital, parent participants will be asked how feasible it has been to follow their baby's discharge plan, including feeding instructions, practicing safe sleep, administering medications, and following up with their pediatrician. | 1-month Post-Discharge |