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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 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.

Results posted on

2025-06-27

Participant Flow

Participant milestones

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

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
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

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

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

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

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 year

Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)

Outcome measures

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

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

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

PREEMIE PROGRESS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 513-5580132

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place