PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

Not Applicable

Completed

• Conditions: Premature Infant Disease; Patient Empowerment; Family Research; Parenting; Parent-Child Relations; Self Efficacy; Chronic Conditions, Multiple; Patient Engagement
• Interventions: Behavioral: PREEMIE PROGRESS; Behavioral: Attention Control

• Registration Number: NCT04638127
• Lead Sponsor: University of Cincinnati

Brief Summary

The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

Detailed Description

Increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. These infants experience increased healthcare utilization, long durations of stay in the Neonatal Intensive Care Unit (NICU), and are at high risk of developing prematurity-related complications. As a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. This research aims to 1) refine a novel family management program, called PREEMIE PROGRESS, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. This project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that PREEMIE PROGRESS addresses key program elements that will be important for future adoption and implementation in NICU settings. We anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. The long-term goal of this project is to develop, test, and translate into NICU practice an efficacious family management intervention for parents of preterm infants. Dr. Weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Study Start: 2022-05-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• English-speaking parents
• Parents preterm infants born 25 0/7-31 6/7 weeks gestational age (GA)
• Parents who had a singleton or twin birth
• Parents 18 years of age or older

Exclusion Criteria

• Mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent
• Infants with imminent or probable death based on the healthcare team's judgement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREEMIE PROGRESS	PREEMIE PROGRESS	PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant.
Attention Control	Attention Control	To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.

Primary Outcome Measures

Name	Time	Method
Receipt of mother's human milk	Category determined at 36 weeks corrected gestional age	(exclusive, partial, none)
Self -Report of Hospital readmissions & ER visits	Readmisssions/ER visits counted within 30 days of discharge will be assessed date of NICU discharge will be assessed until study completion, with maximum of 1 year	Raw count w/in 30 days of discharge (self-report by phone)
Parent Self-Rating of Depression	2 weeks after baseline visit	Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: T-score: standardized score mean of 50 and standard deviation (SD) of 10
Parent Self-Rating of Anxiety	2 weeks after baseline visit	Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: T-score: standardized score mean of 50 and standard deviation (SD) of 10
Z score of weight gain at 36 weeks corrected gestational age	Caculated for the date that infant is 36 weeks corrected gestational age	Z-score method
NICU Length of Stay	Date of NICU discharge will be assessed until study completion, with maximum of 1 year	Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States