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

NCT04638127 | Completed Results

• 2 other identifiers: 2019-04751K23NR019081
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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.

• 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

• 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.

Study Arms (2)

PREEMIE PROGRESS

EXPERIMENTAL

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

Attention Control

ACTIVE COMPARATOR

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

Interventions

PREEMIE PROGRESS BEHAVIORAL

PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).

PREEMIE PROGRESS

Attention Control BEHAVIORAL

usual care and welcome videos

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Related Publications (1)

• Weber A, Bakas T, Oudat Q, Parikh NA, Lambert J, Tubbs-Cooley HL, Rice J, Voos K, Rota M, Kaplan HC. An Internet-Based and Mobile Family Management Intervention for Mothers of Very Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (the Preemie Progress Program): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 May 21;9:e66073. doi: 10.2196/66073.

  PMID: 40397935 DERIVED

MeSH Terms

Conditions

Patient Participation; Multiple Chronic Conditions; Premature Birth

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Principal Investigator: Ashley Weber, PhD, RN, RNC-NIC
• Organization: University of Cincinnati

ashley.weber@uc.edu

513-5580132

Study Officials

• Ashley M Weber, PhD, RN, RNC-NIC

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 20, 2020
• Study Start: May 17, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Locations

US (1)