Clinical trial NCT04638127: PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Official title: PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant Disease
Family Research
Parent-Child Relations
Self Efficacy
Patient Engagement
Patient Empowerment
Parenting
Chronic Conditions, Multiple
Keywords: neonatal intensive care unit
prematurity
family management
self-management
patient education
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-11-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent Self-Rating of Depression
timeFrame: 2 weeks after baseline visit
measure: Parent Self-Rating of Anxiety
timeFrame: 2 weeks after baseline visit
measure: Receipt of mother's human milk
timeFrame: Category determined at 36 weeks corrected gestional age
measure: Z score of weight gain at 36 weeks corrected gestational age
timeFrame: Caculated for the date that infant is 36 weeks corrected gestational age
measure: NICU Length of Stay
timeFrame: Date of NICU discharge will be assessed until study completion, with maximum of 1 year
measure: Self -Report of Hospital readmissions & ER visits
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Ashley M Weber, PhD, RN, RNC-NIC
role: PRINCIPAL_INVESTIGATOR
References: