An interventional study of PREEMIE PROGRESS and Attention Control in Premature Infant Disease, Family Research and Parent-Child Relations, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Supportive care
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.
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.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's enrollment of 64 is below the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
Browse Multiple Chronic Conditions studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
Compared within Multiple Chronic Conditions, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Patient Participation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: PREEMIE PROGRESS
To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.
Behavioral: Attention Control
PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
usual care and welcome videos
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.
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.
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).
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.
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
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.
| Milestone | PREEMIE PROGRESS | Attention Control |
|---|---|---|
| Started | 33 | 31 |
| Completed | 16 | 26 |
| Not completed | 17 | 5 |
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.
| T-score mean changes | PREEMIE PROGRESS | Attention Control |
|---|---|---|
| T2 - Baseline | -3.75 ± 1.70 | -4.08 ± 1.42 |
| T3 - Baseline | -2.21 ± 1.58 | -2.50 ± 1.35 |
| T4 - Baseline | -4.08 ± 1.42 | -3.75 ± 1.70 |
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.
| T-score | PREEMIE PROGRESS | Attention Control |
|---|---|---|
| T2-Baseline | -3.08 ± 1.74 | -1.96 ± 1.52 |
| T3-Baseline | 2.87 ± 1.77 | -3.91 ± 1.53 |
| T4-Baseline | -4.67 ± 1.59 | -7.54 ± 1.93 |
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
| Participants | PREEMIE PROGRESS | Attention Control |
|---|---|---|
| Baseline | 17 | 18 |
| T2 | 13 | 15 |
| T3 | 14 | 10 |
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 = \[Zscore at 36 weeks corrected gestational age\] - \[Zscore at birth\]
| Z-score | PREEMIE PROGRESS | Attention Control |
|---|---|---|
| Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age | -0.8 (-1.36 to -0.51) | -0.72 (-1.11 to -0.39) |
Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)
| days | Attention Control | PREEMIE PROGRESS |
|---|---|---|
| NICU Length of Stay | 68.3 ± 36.3 | 57.2 ± 23.4 |
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.
| Participants | Attention Control | PREEMIE PROGRESS |
|---|---|---|
| Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response | 2 | 4 |
Collected over Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Attention Control | 0/31 (0%) | 0/31 (0%) | 3/31 (9.7%) |
| PREEMIE PROGRESS | 1/34 (2.9%) | 0/34 (0%) | 0/34 (0%) |
| Event | Attention Control | PREEMIE PROGRESS |
|---|---|---|
| Psychological Distress, Clinical significant Anxiety or DepressionPsychiatric disorders | 3/31 | 0/34 |
| Age, Continuous(years) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Mean | 29.1 ± 6.7 | 30.5 ± 4.3 | 29.8 ± 5.7 |
| Age, Customized(weeks) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Infant gestation at birth (wks) | 29.2 ± 1.8 | 29.3 ± 2.1 | 29.2 ± 1.9 |
| Sex: Female, Male(Participants) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Female | 16 | 8 | 24 |
| Male | 17 | 23 | 40 |
| Ethnicity (NIH/OMB)(Participants) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 30 | 29 | 59 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Race (NIH/OMB)(Participants) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 10 | 23 |
| White | 18 | 17 | 35 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| United States | 33 | 31 | 64 |
| Birth weight (g)(grams) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Mean | 1253.9 ± 392.4 | 1286.2 ± 359.2 | 1269 ± 374 |
| Income (in $10,000)(Annual income in $10,000) | PREEMIE PROGRESS | Attention Control | Total |
|---|---|---|---|
| Mean | 47000 ± 39000 | 44000 ± 39000 | 45400 ± 39000 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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