PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Phase: NA
Conditions: Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy, Patient Engagement, Patient Empowerment, Parenting, Chronic Conditions, Multiple
Sponsor: University of Cincinnati

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PREEMIE PROGRESS: A family management program for parents of preterm infants 
ClinicalTrials.gov Identiﬁer: NCT04638127 
NIH NINR: 1K23NR019081 
Document Date: 2020-10-22 
 
Study Protocol and Statistical Analysis Plan 
 
 

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Study Protocol 
Study Description 
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. 
 
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 eƯectively 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 eƯicacious 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 Design  
Study Type: Interventional (Clinical Trial) 
Primary Purpose: Supportive Care 
Intervention Model: Parallel Assignment 
Actual Enrollment: 44 Participants 
Number of Arms: 2 
Masking: Triple (Participant, Care Provider, Outcomes Assessor)  
Allocation: Randomized 
Enrollment [Actual]: 64 mothers of very preterm infants 
 
Arms and Interventions:   
PREEMIE PROGRESS arm: 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. PREEMIE PROGRESS is a video-based training program for parents of preterm infants 
hospitalized in the neonatal intensive care unit (NICU). 
 Attention Control arm: To maintain their attention, control parents will view “Welcome Videos” that explain hand 
hygiene, visitor IDs, parking, etc. on their mobile devices. 
 
 

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Randomization 
Using STATA software, the Statistician will generate a random allocation sequence stratified by GA at birth (GA 
<28 weeks and >28 weeks) to balance representation of the youngest and sickest infants. We will use 
permuted block randomization for each stratum, with block sizes of 2, 4, and 6 and a 1:1 treatment allocation. 
The Statistician will upload the sequence into REDCap, have no contact with subjects, and will be independent 
of all assessment procedures. REDCap’s secure randomization feature prevents the study team from viewing 
the treatment allocation sequence, ensuring allocation concealment. Research assistants will enroll and collect 
baseline data before randomization. The Principal Investigator (PI) / Clinical Research Coordinator (CRC) will 
randomize each family after baseline survey completion to minimize dropout effects on randomization. 
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
Outcome Measures 
Measure Title 
Maternal Self-Rating of Depression 
Measure Description
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 
Time Frame 
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. 
Measure Title 
Maternal Self-Rating of Anxiety 
Measure Description 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 
Time Frame 
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. 
Measure Title 
Receipt of Mother's Human Milk 
Measure Description (exclusive, partial, none). 
Time Frame 
Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3). Reported here is 28 days 
post-baseline (T3). 
Measure Title 
Z Score of Weight Gain at 36 Weeks Corrected Gestational Age 
Measure Description Z-score method; Z score Δ weight (g), Birthweight (g) - infant weight (g) at 36 weeks corrected 
gestational age 
Time Frame 
Calculated for the date that infant is 36 weeks corrected gestational age 
Measure Title 
NICU Length of Stay 
Measure Description Days of NICU hospitalization (calculated from days between date of birth to date of discharge from 
NICU) 
Time Frame 
Date of NICU discharge will be assessed until study completion, with maximum of 1 year 
Measure Title 
Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant 
Discharge. 
Measure Description Coded as Yes/No and extracted from the infant’s electronic health record. 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. 
Time Frame 
Readmissions/ER visits counted within 30 days of discharge will be assessed date of NICU discharge 
will be assessed until study completion, with maximum of 1 year 

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Statistical analysis plan 
Data Management.  
All study data and tracking will be entered into an research electronic data system, REDCap 
(www.REDCap.org), a secure research electronic data management system with validated data entry, audit 
trails for tracking data manipulation and export procedures. It is HIPAA complaint satisfying all local, state, and 
federal regulation for the capture and storage of private health information for research purposes. 
Power 
We aimed to enroll at least 60 mothers (30 mothers per arm), with planned over recruitment to account for up 
to 20% loss to follow-up (i.e., 72 infants) during the pilot trial. Because we did not have reliable estimates for 
the confidence intervals, standard errors, or mean differences for our outcomes a priori, our sample size was 
based on Whitehead’s recommendations to have at least 20 persons per treatment arm in a pilot trial when 
expecting a small standardized difference (δ=0.2) to achieve at least 80% in the main trial. Because our 
emphasis was on feasibility, this pilot trial was not powered to detect statistically significant changes in 
outcome and mediating variables between arms.  
Analysis 
REDCAP data will be exported to Stata 15 software, where we will analyze sources of missing data and 
calculate descriptive/summary statistics. We will graph trends for all variables over infant Day of Life (DOL) and 
CGA, comparing boxplots between arms and over time. We will compute means and 95% CIs for changes 
from baseline (T1 to T2-4) for each outcome by arm. At each follow-up (T2-4), we will compute mean 
differences and 95% CI between arms to evaluate trends in outcomes. Mothers with multiple births will have 
one infant randomly selected for analysis. We will not test for statistically significant differences between 
groups in outcome measures or estimate effect sizes in this pilot study, because the primary purpose is to 
determine feasibility of our procedures to inform the planning and design of a larger trial.