N/A
Completed N=64
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Premature Infant Disease · Family Research · Parent-Child Relations · Self Efficacy
Source: ClinicalTrials.gov NCT04638127 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Maternal Self-Rating of Depression — -3.75; -4.08; -2.21; -2.50 T-score mean changes
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.
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 | — |
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
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. Informational only — not medical advice.