Premature Infant DiseaseNCT04638127

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

A study testing PREEMIE PROGRESS in people with Premature Infant Disease and Family Research, run by University of Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Premature Infant Disease, Family Research, Parent-Child Relations
What is being tested?: PREEMIE PROGRESS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 17 May 2022to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Cincinnati
Cincinnati, Ohio, 45221

Other trials in United States

About this study

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.

Read the 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.

Conditions: Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy, Patient Engagement, Patient Empowerment
Being tested: PREEMIE PROGRESS, Attention Control
Keywords: neonatal intensive care unit, prematurity, family management, self-management, patient education
Medical subject headings: Patient Participation, Multiple Chronic Conditions, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PREEMIE PROGRESSBehavioural
PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
Attention ControlBehavioural
usual care and welcome videos

Study groups in NCT04638127
Study group	Role	What they receive
PREEMIE PROGRESS	Experimental	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. Receives: Behavioral: PREEMIE PROGRESS
Attention Control	Active comparator	To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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]
Measured: 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)
Measured: 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.
Measured: Thirty days after infant discharge from the NICU.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 202231 Dec 2023

First posted20 Nov 2020
Study start17 May 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Premature Infant DiseaseStudies of the same condition, open and under way.
More trials run by University of CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04638127
Sponsor's protocol ID: 2019-0475
Other IDs: 1K23NR019081
Status last verified: Jun 2025
First submitted: 22 Oct 2020
Last updated: 27 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Weber A, Bakas T, Oudat Q, Parikh NA, Lambert J, Tubbs-Cooley HL, Rice J, Voos K, Rota M, Kaplan HC. An Internet-Based and Mobile Family Management Intervention for Mothers of Very Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (the Preemie Progress Program): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 May 21;9:e66073. doi: 10.2196/66073.
PubMed 40397935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Premature Infant Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
ClinicalTrials.gov ID: NCT04638127
Acronym / sponsor ID: 2019-0475
Conditions: Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy, Patient Engagement, Patient Empowerment
Keywords: neonatal intensive care unit, prematurity, family management, self-management, patient education
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 17 May 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 20 Nov 2020 (actual)
Results: Posted 27 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PREEMIE PROGRESS	Experimental	Behavioral: PREEMIE PROGRESSPREEMIE 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.
Attention Control	Active comparator	Behavioral: Attention ControlTo maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PREEMIE PROGRESSPREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).	Behavioural	PREEMIE PROGRESS
Attention Controlusual care and welcome videos	Behavioural	Attention Control

Primary outcome

Maternal Self-Rating of Depression
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.
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 Anxiety
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.
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 Milk
Time frame: 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
Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age
Time frame: Z 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 Stay
Time frame: 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)
Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response
Time frame: Thirty 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.

Results and safety

Results posted to the registry on 27 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PREEMIE PROGRESS	33	16
Attention Control	31	26

Primary outcome: Maternal Self-Rating of Depression

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.. Mean (Standard Error). Unit: T-score mean changes

Measure	PREEMIE PROGRESS n = 33	Attention Control n = 31
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)

Population analysed: 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).

Primary outcome: Maternal Self-Rating of Anxiety

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.. Mean (Standard Error). Unit: T-score

Measure	PREEMIE PROGRESS n = 33	Attention Control n = 31
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)

Primary outcome: Receipt of Exclusive Mother's Human Milk

Time frame: Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3).. Count of participants. Unit: Participants

Measure	PREEMIE PROGRESS n = 33	Attention Control n = 30
Baseline	17	18
T2	13	15
T3	14	10

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

Primary outcome: Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age

Time frame: Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth.. Median (Inter-Quartile Range). Unit: Z-score

Measure	PREEMIE PROGRESS n = 33	Attention Control n = 31
Value	-0.8 (-1.36 to -0.51)	-0.72 (-1.11 to -0.39)

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

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Attention Control	0 of 31 (0%)	3 of 31 (9.7%)	0 of 31
PREEMIE PROGRESS	0 of 34 (0%)	0 of 34 (0%)	1 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40397935Weber A, Bakas T, Oudat Q, Parikh NA, Lambert J, Tubbs-Cooley HL, Rice J, Voos K, Rota M, Kaplan HC. An Internet-Based and Mobile Family Management Intervention for Mothers of Very Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (the Preemie Progress Program): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 May 21;9:e66073. doi: 10.2196/66073.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ashley M Weber, PhD, RN, RNC-NIC principal investigator

University of Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PREEMIE PROGRESS in people with Premature Infant Disease and Family Research, run by University of Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Self-Rating of Depression (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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638127, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.