Trial Outcomes & Findings for PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants (NCT NCT04638127)
NCT ID: NCT04638127
Last Updated: 2025-06-27
Results Overview
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.
COMPLETED
NA
64 participants
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.
2025-06-27
Participant Flow
Participant milestones
| Measure |
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).
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
|
Overall Study
COMPLETED
|
16
|
26
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Baseline characteristics by cohort
| Measure |
PREEMIE PROGRESS
n=33 Participants
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).
|
Attention Control
n=31 Participants
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
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
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29.1 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
30.5 years
STANDARD_DEVIATION 4.3 • n=107 Participants
|
29.8 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Age, Customized
Infant gestation at birth (wks)
|
29.2 weeks
STANDARD_DEVIATION 1.8 • n=99 Participants
|
29.3 weeks
STANDARD_DEVIATION 2.1 • n=107 Participants
|
29.2 weeks
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Birth weight (g)
|
1253.9 grams
STANDARD_DEVIATION 392.4 • n=99 Participants
|
1286.2 grams
STANDARD_DEVIATION 359.2 • n=107 Participants
|
1269 grams
STANDARD_DEVIATION 374 • n=206 Participants
|
|
Income (in $10,000)
|
47000 Annual income in $10,000
STANDARD_DEVIATION 39000 • n=99 Participants
|
44000 Annual income in $10,000
STANDARD_DEVIATION 39000 • n=107 Participants
|
45400 Annual income in $10,000
STANDARD_DEVIATION 39000 • n=206 Participants
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System)8a Anxiety
|
53.4 T-score
STANDARD_DEVIATION 8.8 • n=99 Participants
|
57.3 T-score
STANDARD_DEVIATION 76.9 • n=107 Participants
|
55.2 T-score
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
PROMIS (Patient-Reported Outcomes Measurement Information System)8a Depression
|
48.1 T-score
STANDARD_DEVIATION 8.6 • n=99 Participants
|
49.3 T-score
STANDARD_DEVIATION 8 • n=107 Participants
|
48.7 T-score
STANDARD_DEVIATION 8.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
PREEMIE PROGRESS
n=33 Participants
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).
|
Attention Control
n=31 Participants
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
|
|---|---|---|
|
Maternal Self-Rating of Depression
T2 - Baseline
|
-3.75 T-score mean changes
Standard Error 1.70
|
-4.08 T-score mean changes
Standard Error 1.42
|
|
Maternal Self-Rating of Depression
T3 - Baseline
|
-2.21 T-score mean changes
Standard Error 1.58
|
-2.50 T-score mean changes
Standard Error 1.35
|
|
Maternal Self-Rating of Depression
T4 - Baseline
|
-4.08 T-score mean changes
Standard Error 1.42
|
-3.75 T-score mean changes
Standard Error 1.70
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PREEMIE PROGRESS
n=33 Participants
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).
|
Attention Control
n=31 Participants
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
|
|---|---|---|
|
Maternal Self-Rating of Anxiety
T2-Baseline
|
-3.08 T-score
Standard Error 1.74
|
-1.96 T-score
Standard Error 1.52
|
|
Maternal Self-Rating of Anxiety
T3-Baseline
|
2.87 T-score
Standard Error 1.77
|
-3.91 T-score
Standard Error 1.53
|
|
Maternal Self-Rating of Anxiety
T4-Baseline
|
-4.67 T-score
Standard Error 1.59
|
-7.54 T-score
Standard Error 1.93
|
PRIMARY outcome
Timeframe: 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).
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
Outcome measures
| Measure |
PREEMIE PROGRESS
n=33 Participants
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).
|
Attention Control
n=30 Participants
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
|
|---|---|---|
|
Receipt of Exclusive Mother's Human Milk
Baseline
|
17 Participants
|
18 Participants
|
|
Receipt of Exclusive Mother's Human Milk
T2
|
13 Participants
|
15 Participants
|
|
Receipt of Exclusive Mother's Human Milk
T3
|
14 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.Population: Z score Δ = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]
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 = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]
Outcome measures
| Measure |
PREEMIE PROGRESS
n=33 Participants
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).
|
Attention Control
n=31 Participants
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
|
|---|---|---|
|
Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age
|
-0.8 Z-score
Interval -1.36 to -0.51
|
-0.72 Z-score
Interval -1.11 to -0.39
|
PRIMARY outcome
Timeframe: Date 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)
Outcome measures
| Measure |
PREEMIE PROGRESS
n=31 Participants
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).
|
Attention Control
n=33 Participants
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
|
|---|---|---|
|
NICU Length of Stay
|
68.3 days
Standard Deviation 36.3
|
57.2 days
Standard Deviation 23.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PREEMIE PROGRESS
n=31 Participants
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).
|
Attention Control
n=33 Participants
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
|
|---|---|---|
|
Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response
|
2 Participants
|
4 Participants
|
Adverse Events
Attention Control
PREEMIE PROGRESS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Attention Control
n=31 participants at risk
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
|
PREEMIE PROGRESS
n=34 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Psychological Distress, Clinical significant Anxiety or Depression
|
9.7%
3/31 • Number of events 3 • Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4).
|
0.00%
0/34 • Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4).
|
Additional Information
Principal Investigator: Ashley Weber, PhD, RN, RNC-NIC
University of Cincinnati
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place