N/A N=64 Randomized Triple-blind Supportive Care

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

Premature Infant Disease · Family Research · Parent-Child Relations · Self Efficacy · Patient Engagement

Bottom Line

View on ClinicalTrials.gov: NCT04638127 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Maternal Self-Rating of Depression — -3.75; -4.08; -2.21; -2.50 T-score mean changes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PREEMIE PROGRESS (Behavioral); Attention Control (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Maternal Self-Rating of Depression	-3.75; -4.08; -2.21; -2.50; -4.08; -3.75	—
PRIMARY Maternal Self-Rating of Anxiety	-3.08; -1.96; 2.87; -3.91; -4.67; -7.54	—
PRIMARY Receipt of Exclusive Mother's Human Milk	17; 18; 13; 15; 14; 10	—
PRIMARY Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age	-0.8; -0.72	—
PRIMARY NICU Length of Stay	68.3; 57.2	—
PRIMARY Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response	2; 4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04638127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.