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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04638127
Enrollment
64
Registered
2020-11-20
Start date
2022-05-17
Completion date
2023-12-31
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Conditions, Multiple, Family Research, Parent-Child Relations, Parenting, Patient Empowerment, Patient Engagement, Premature Infant Disease, Self Efficacy

Keywords

neonatal intensive care unit, prematurity, family management, self-management, patient education

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.

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 effectively 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 efficacious 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.

Interventions

BEHAVIORALPREEMIE PROGRESS

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

BEHAVIORALAttention Control

usual care and welcome videos

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal Self-Rating of DepressionAssessed 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.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.
Maternal Self-Rating of AnxietyAssessed 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.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.
Receipt of Exclusive Mother's Human MilkAssessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).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
Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational AgeZ scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.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 = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]
NICU Length of StayDate of NICU discharge will be assessed until study completion, with maximum of 1 yearDays of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)
Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES ResponseThirty days after infant discharge from the NICU.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
PREEMIE PROGRESS
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: PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
33
Attention Control
To maintain their attention, control parents will view Welcome Videos that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Attention Control: usual care and welcome videos
31
Total64

Baseline characteristics

CharacteristicPREEMIE PROGRESSAttention ControlTotal
Age, Continuous29.1 years
STANDARD_DEVIATION 6.7
30.5 years
STANDARD_DEVIATION 4.3
29.8 years
STANDARD_DEVIATION 5.7
Age, Customized
Infant gestation at birth (wks)
29.2 weeks
STANDARD_DEVIATION 1.8
29.3 weeks
STANDARD_DEVIATION 2.1
29.2 weeks
STANDARD_DEVIATION 1.9
Birth weight (g)1253.9 grams
STANDARD_DEVIATION 392.4
1286.2 grams
STANDARD_DEVIATION 359.2
1269 grams
STANDARD_DEVIATION 374
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants29 Participants59 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants1 Participants4 Participants
Income (in $10,000)47000 Annual income in $10,000
STANDARD_DEVIATION 39000
44000 Annual income in $10,000
STANDARD_DEVIATION 39000
45400 Annual income in $10,000
STANDARD_DEVIATION 39000
PROMIS (Patient-Reported Outcomes Measurement Information System)8a Anxiety53.4 T-score
STANDARD_DEVIATION 8.8
57.3 T-score
STANDARD_DEVIATION 76.9
55.2 T-score
STANDARD_DEVIATION 9.7
PROMIS (Patient-Reported Outcomes Measurement Information System)8a Depression48.1 T-score
STANDARD_DEVIATION 8.6
49.3 T-score
STANDARD_DEVIATION 8
48.7 T-score
STANDARD_DEVIATION 8.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
13 Participants10 Participants23 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
18 Participants17 Participants35 Participants
Region of Enrollment
United States
33 Participants31 Participants64 Participants
Sex: Female, Male
Female
16 Participants8 Participants24 Participants
Sex: Female, Male
Male
17 Participants23 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 311 / 34
other
Total, other adverse events
3 / 310 / 34
serious
Total, serious adverse events
0 / 310 / 34

Outcome results

Primary

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 = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]

Time frame: Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.

Population: Z score Δ = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]

ArmMeasureValue (MEDIAN)
PREEMIE PROGRESSChange in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age-0.8 Z-score
Attention ControlChange in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age-0.72 Z-score
Primary

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.

Time frame: Thirty days after infant discharge from the NICU.

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PREEMIE PROGRESSInfant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response2 Participants
Attention ControlInfant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response4 Participants
Primary

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.

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.

Population: The percent of videos mothers watched were controlled in our analyses showing data trends as change scores. At each follow-up time point \[14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4)\], we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline at each time point in the study.

ArmMeasureGroupValue (MEAN)Dispersion
PREEMIE PROGRESSMaternal Self-Rating of AnxietyT2-Baseline-3.08 T-scoreStandard Error 1.74
PREEMIE PROGRESSMaternal Self-Rating of AnxietyT3-Baseline2.87 T-scoreStandard Error 1.77
PREEMIE PROGRESSMaternal Self-Rating of AnxietyT4-Baseline-4.67 T-scoreStandard Error 1.59
Attention ControlMaternal Self-Rating of AnxietyT2-Baseline-1.96 T-scoreStandard Error 1.52
Attention ControlMaternal Self-Rating of AnxietyT3-Baseline-3.91 T-scoreStandard Error 1.53
Attention ControlMaternal Self-Rating of AnxietyT4-Baseline-7.54 T-scoreStandard Error 1.93
Primary

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.

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.

Population: The percent of videos mothers watched were controlled in our analyses showing data trends as change scores. At each follow-up time point \[14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4)\], we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline to 30 days after infant discharge from the NICU (T4).

ArmMeasureGroupValue (MEAN)Dispersion
PREEMIE PROGRESSMaternal Self-Rating of DepressionT2 - Baseline-3.75 T-score mean changesStandard Error 1.7
PREEMIE PROGRESSMaternal Self-Rating of DepressionT3 - Baseline-2.21 T-score mean changesStandard Error 1.58
PREEMIE PROGRESSMaternal Self-Rating of DepressionT4 - Baseline-4.08 T-score mean changesStandard Error 1.42
Attention ControlMaternal Self-Rating of DepressionT2 - Baseline-4.08 T-score mean changesStandard Error 1.42
Attention ControlMaternal Self-Rating of DepressionT3 - Baseline-2.50 T-score mean changesStandard Error 1.35
Attention ControlMaternal Self-Rating of DepressionT4 - Baseline-3.75 T-score mean changesStandard Error 1.7
Primary

NICU Length of Stay

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

ArmMeasureValue (MEAN)Dispersion
PREEMIE PROGRESSNICU Length of Stay68.3 daysStandard Deviation 36.3
Attention ControlNICU Length of Stay57.2 daysStandard Deviation 23.4
Primary

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

Time frame: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).

Population: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PREEMIE PROGRESSReceipt of Exclusive Mother's Human MilkT314 Participants
PREEMIE PROGRESSReceipt of Exclusive Mother's Human MilkBaseline17 Participants
PREEMIE PROGRESSReceipt of Exclusive Mother's Human MilkT213 Participants
Attention ControlReceipt of Exclusive Mother's Human MilkT215 Participants
Attention ControlReceipt of Exclusive Mother's Human MilkT310 Participants
Attention ControlReceipt of Exclusive Mother's Human MilkBaseline18 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026