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

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638127
• Other study ID #: 2019-0475
• Secondary ID: 1K23NR019081
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Chronic Disease
• Family Research
• Infant, Premature, Diseases
• Multiple Chronic Conditions
• Parent-Child Relations
• Parenting
• Patient Empowerment
• Patient Engagement
• Premature Infant Disease
• Self Efficacy

Intervention

Behavioral:
• PREEMIE PROGRESS
PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
• Attention Control
usual care and welcome videos

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Self-Rating of Depression	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	2 weeks after baseline visit
Primary	Parent Self-Rating of Anxiety	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	2 weeks after baseline visit
Primary	Receipt of mother's human milk	(exclusive, partial, none)	Category determined at 36 weeks corrected gestional age
Primary	Z score of weight gain at 36 weeks corrected gestational age	Z-score method	Caculated for the date that infant is 36 weeks corrected gestational age
Primary	NICU Length of Stay	Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)	Date of NICU discharge will be assessed until study completion, with maximum of 1 year
Primary	Self -Report of Hospital readmissions & ER visits	Raw count w/in 30 days of discharge (self-report by phone)	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