Accepted for/Published in: JMIR Formative Research
Date Submitted: Nov 4, 2024
Date Accepted: Mar 16, 2025
Family Management Intervention for Mothers of Very Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (PREEMIE PROGRESS): A Pilot Randomized Controlled Trial
ABSTRACT
Background:
Flexible approaches to parenting training interventions in the Neonatal Intensive Care Unit (NICU), including Family-Integrated Care (FICare) models, are urgently needed across the globe. Many FICare trials inadvertently exclude parents with low resources who cannot commit to daily infant care (e.g., 4-8 hours per day). PREEMIE PROGRESS is a video-based training program that allows parents to choose when and where they learn, without requiring parent bedside presence.
Objective:
Examine feasibility of recruitment, retention, fidelity, and changes in outcomes during a pilot of PREEMIE PROGRESS (PP), a video-based intervention training mothers of very preterm infants evidence-based family management skills in the Neonatal Intensive Care Unit (NICU).
Methods:
Design: Prospective, two-parallel arm, double-blinded, randomized pilot trial. Mothers of infants born 250/7 - 316/7 gestation were enrolled in one MidWestern United States NICU. Esurveys were sent to collect maternal outcomes (PROMIS8a Depression/Anxiety) at baseline (T1); 14 days (T2) and 28 days (T3) postbaseline; 30 days after NICU discharge (T4). Infant electronic health records were extracted to collect infant (i.e., weight gain velocity at 36 weeks, receipt of mother’s milk) and healthcare outcomes (i.e., NICU length of stay; readmissions/emergency visits within 30 days of discharge).
Results:
Of 123 eligible mothers, 64 were randomized (PP=33; Attention-control (AC)=31; 52.0% recruitment rate). Loss to follow-up in PP arm was 30.3% (AC=12.9%). PP mothers watched a mean (SD) 17.8 (18.9) of 49 videos. PP retention was linked to higher fidelity. PP mothers showed greater reductions in anxiety 30 days after discharge (T4: -7.54 (1.93); 95% CI [-11.32, -3.76]) than AC mothers (T4: -4.67 (1.59); 95% CI [-7.80, -1.55]). PP infants trended toward greater receipt of exclusive mother’s milk 28 days postbaseline (PP=14/26, 58.6%; AC=10/28, 41.6%); decreased NICU stay (PP= 57.2 days; AC= 68.3 days), but higher readmissions (PP=4/33, 12.1%; AC=2/31, 6.5%).
Conclusions:
We were able to recruit a diverse sample of mothers from a range of socioeconomic backgrounds, including mothers experiencing barriers to bedside presence. Recruitment goals were met. PP showed promising trends in improving maternal, infant, and healthcare outcomes. Additional studies are needed to optimize PP and study procedures to improve retention and fidelity. PP has potential to support parent training outside of traditional FICare models, or serve as a complement to structure Education Pillars of adapted FICare models. Clinical Trial: Registered prospectively with ClinicalTrials.gov (#NCT04638127) on 10/22/2020.
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