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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: PREEMIE PROGRESS; PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
Active Comparator: Attention Control; To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.	Behavioral: Attention Control; usual care and welcome videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maternal 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 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms.	Assessed at Baseline14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported.
Maternal 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 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms.	Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported.
Receipt of Exclusive Mother's Human Milk	Number of infants receiving exclusive mother's milk were recorded and percent of infants was calculated from the total number number of infants receiving enteral feeds. Infants were marked as receiving exclusive mother's milk if all feeds were mother's milk (i.e., infant did not receive donor milk or formula). Percent of infants receiving exclusive mother's milk = Number of infants receiving exclusive mother's milk / Number of infants on enteral feeds	Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).
Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age	Change in Z score weight from birth to 36 weeks corrected gestational age (or at discharge if earlier) was calculated using PediTools Fenton 2013 Growth Calculator for Preterm Infants. Z-scores are the number of standard deviations above or below a growth chart's center (mean) curve. A Fenton preterm growth chart Z-score of 0 means the infant's growth measurement (e.g., weight) is at the average (mean) for their age and sex. Changes in Z-scores tell if a second measurement is closer or further away from the growth chart center than the previous measurement. Change in Z-score of 0 means the infant's percentile on the growth chart did not change. Higher Z scores indicate increased growth acceleration. The Academy of Nutrition and Dietetics considers Z score changes less than -0.8 to indicate growth failure. Normal growth during NICU hospitalization is defined as a z-score change of -0.79 to 0.79. Z score Δ = [Zscore at 36 weeks corrected gestational age] - [Zscore at birth]	Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.
Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response	The infant's electronic health record was reviewed for hospital readmissions and emergency department visits within 30 days of infant discharge. Mothers were also asked "Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?", to ensure all rehospitalizations and ED visits were captured.	Thirty days after infant discharge from the NICU.

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Ashley M Weber, PhD, RN, RNC-NIC, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: self-management; patient education; prematurity; neonatal intensive care unit; family management
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infant, Newborn, Diseases; Multiple Chronic Conditions; Infant, Premature, Diseases; Chronic Disease
• Other Study ID Numbers: 2019-0475; 1K23NR019081 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No