Premature InfantsNCT04555590
Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants
A study testing H-HOPE Intervention in people with Premature Infants and Parent-Child Relations, run by Medical College of Wisconsin at 4 sites in United States.
Trial summary
Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Infants, Parent-Child Relations
- What is being tested?
- H-HOPE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,882 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Nov 2020to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- born between 23-35 weeks gestational age (GA)
- have reached 31-32 weeks post menstrual age (PMA)
- clinically stable
- male or female
- could be receiving oxygen or intravenous therapy
- could have been previously intubated for mechanical ventilation
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- assessed as ready to begin social interaction Infants of multiple births will be eligible to participate but data from only one randomly selected infant will be used in analysis of Aim 2.
- Inclusion criteria for the parent (up to 2 per infant can be in the study:
- mother, father, other family member, or surrogate parent regardless of age, race/ethnicity, gender, or sexual orientation, or biological relationship to the infant
- intends to act in the role of parent
- 18 years of age or older
- English or Spanish speaking
- Hospital Administrator - staff member with an administrative role outside of the NICU leadership who is knowledgeable about the activities of the NICU NICU Manager - Nurse or physician with an administrative role in the NICU (e.g. medical director or nurse manager) H-HOPE Team member - staff member who is part of the H-HOPE Team NICU Staff Nurse - registered nurse who provides direct patient care and works a minimum of 50% in the NICU Exclusion Criteria We will not be limiting any participants based on sex/gender, or ethnic/racial identity. Differences due to race and gender will be accounted for during data analysis. We will be limiting enrollment to English or Spanish speaking parents due to the limited availability of valid measures for data collection in languages other than English and Spanish. However, we anticipate that we will still be able to recruit an ethnically diverse group of parents because of the ethnic composition of the parents at the sites and our prior experience.
Who cannot join
- major brain injuries (e.g. cystic PVL)
- current sepsis
- intubated for mechanical ventilation at time of enrollment
- surgical necrotizing enterocolitis
- Ward of the State
- positive drug screen for illegal substances
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- planning to surrender custody of the infant or legal custody remove
- primary parent does not have legal guardianship of the infant
- Mental health diagnosis such as Psychosis, Bipolar Disease Exclusion Criteria Hospital Personnel
- None
- less than 50% effort.
- does not provide direct patient care
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago
Chicago, Illinois, 60637
Duke Univesity
Durham, North Carolina, 27708
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Advocate Aurora Health
Park Ridge, Illinois, 60068
About this study
Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with infants in the NICU and the transition to home. In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H-HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offering H-HOPE), Reach (% of eligible parent/infant dyads receiving H-HOPE) and Degree of Implementation (mean H-HOPE services received per parent-infant unit) (primary implementation outcomes). For Aim 2, effectiveness is analyzed using generalized linear mixed models for infant, cost, and parent outcomes (primary outcomes: infant growth at discharge and acute care visits from discharge to 6-weeks corrected age). Propensity score analysis is used to make the pre- and post-implementation comparable. For Aim 3, a mixed methods analyses is used to identify influences from H-HOPE records and interviews that are associated with implementation success and effectiveness at each site and across sites. This is the first time implementation in a NICU is guided by the evidence-based CFIR framework, and results will make a major contribution to implementation science. This study will produce an evidence-based implementation strategy and Toolkit to disseminate nationwide. Widespread H-HOPE implementation will make a significant change in clinical practice and improve preterm infant health and health care costs.
- Conditions
- Premature Infants, Parent-Child Relations
- Being tested
- H-HOPE Intervention
- Keywords
- Premature Infants, NICU, Parental Stress, Healthcare Costs
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-HOPE InterventionBehavioural
The H-HOPE intervention (Hospital to Home: Optimizing the Preterm Infant's Environment) to promote early infant development and parental engagement. H-HOPE includes ATVV, which provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation with a parent-directed component which provides participatory guidance and social support to engage with their infants.
| Study group | Role | What they receive |
|---|---|---|
| Pre H-HOPE Cohort | No intervention | The Pre-H-HOPE Comparison Cohort will not receive the H-HOPE intervention, and represents the prior standard (non-HOPE). |
| H-HOPE Cohort | Experimental | The H-HOPE Cohort will receive the H-HOPE intervention. Receives: Behavioral: H-HOPE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation)
Change in % of instances of H-HOPE being offered
Measured: Every 2 months from Executing through 6 months after supported implementation ends
Aim 1 Outcome Measure: Implementation Success (Change in Reach throughout implementation)
% of eligible parent-infant units receiving H-HOPE
Measured: Every 2 months from Executing through 6 months after supported implementation ends
Aim 1 Outcome Measure: Implementation Success (Degree of Implementation)
In-Hospital:
Infant: Mean number of ATVV interventions received per eligible day (Range 0-2)
Transition to home:
Parents: # received participatory guidance sessions (2 pre-discharge and 2 screen time visits at 2-3 days and 7-15 days post-discharge; Range: 0-3) Infant: Mean number of ATVV interventions received by per eligible day since discharge (Range 0-2; provided and reported by parent)
Measured: Every 2 months from Executing through 6 months after supported implementation ends
Aim 2 Outcome Measure: Effectiveness-(Change in Infant Head Circumference)
Infant Primary: Infant Head Circumference, measured in centimeters.
Measured: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Aim 2 Outcome Measure: Effectiveness (Change in Infant Weight)
Infant Primary: Weight, measured in kilograms
Measured: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Aim 2 Outcome Measure: Effectiveness (Change in Infant Length)
Infant Primary: Length, measured in centimeters
Measured: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Aim 2 Outcome Measure: Effectiveness (Change in number of Acute Care Visits)
Number of acute care visits (clinic or emergency department visit or re-hospitalization)
Measured: At 6 weeks post discharge
Secondary outcomes (2)
Aim 2 Outcome Measure: Cost
Mean hospitalization cost/day (direct costs) from entry into H-HOPE through discharge, adjusted by adding the cost per H-HOPE infant to implement H-HOPE (training, coordinating, time to deliver H-HOPE and to arrange screen time visits)
Measured: From infant enrollment through infant discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Aim 3 Outcome Measure: CFIR influences (Number of facilitators and barriers to implementation)
Aim 3 uses mixed methods analyses to integrate data collected for this aim regarding influences (facilitators or barriers) in each of the 5 CFIR domains with data from Aim 1 (implementation success) and Aim 2 (effectiveness for the primary infant outcomes).
Measured: From the completion of the first site's Sustaining Phase through Final Analysis of all site data, estimated to be 39 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start16 Nov 2020
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an implementation study of the H-HOPE Intervention. The team uses a Stepped-Wedge Design for Implementation.
- Masking
- None (open label)
- Enrolment
- 1,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University, University of Chicago, Wake Forest University Health Sciences, Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Rosemary White-Traut, Medical College of Wisconsin
- Investigators
- Rosemary White-Traut, PhD,RN,FAAN, Principal investigator, Department of Nursing Research and Evidence-Based Practice Children's Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555590
- Sponsor's protocol ID
- PRO00035600
- Other IDs
- 1R01HD098095-01A1
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White-Traut R, Brandon D, Kavanaugh K, Gralton K, Pan W, Myers ER, Andrews B, Msall M, Norr KF. Protocol for implementation of an evidence based parentally administered intervention for preterm infants. BMC Pediatr. 2021 Mar 24;21(1):142. doi: 10.1186/s12887-021-02596-1.
PubMed 33761902
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants
- ClinicalTrials.gov ID
- NCT04555590
- Acronym / sponsor ID
- PRO00035600
- Conditions
- Premature Infants, Parent-Child Relations
- Keywords
- Premature Infants, NICU, Parental Stress, Healthcare Costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,882 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University, University of Chicago, Wake Forest University Health Sciences, Children's Hospital and Health System Foundation, Wisconsin
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with infants in the NICU and the transition to home. In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H-HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offering H-HOPE), Reach (% of eligible parent/infant dyads receiving H-HOPE) and Degree of Implementation (mean H-HOPE services received per parent-infant unit) (primary implementation outcomes). For Aim 2, effectiveness is analyzed using generalized linear mixed models for infant, cost, and parent outcomes (primary outcomes: infant growth at discharge and acute care visits from discharge to 6-weeks corrected age). Propensity score analysis is used to make the pre- and post-implementation comparable. For Aim 3, a mixed methods analyses is used to identify influences from H-HOPE records and interviews that are associated with implementation success and effectiveness at each site and across sites. This is the first time implementation in a NICU is guided by the evidence-based CFIR framework, and results will make a major contribution to implementation science. This study will produce an evidence-based implementation strategy and Toolkit to disseminate nationwide. Widespread H-HOPE implementation will make a significant change in clinical practice and improve preterm infant health and health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an implementation study of the H-HOPE Intervention. The team uses a Stepped-Wedge Design for Implementation.
| Arm | Type | Receives |
|---|---|---|
| Pre H-HOPE Cohort | No intervention | –The Pre-H-HOPE Comparison Cohort will not receive the H-HOPE intervention, and represents the prior standard (non-HOPE). |
| H-HOPE Cohort | Experimental | Behavioral: H-HOPE InterventionThe H-HOPE Cohort will receive the H-HOPE intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- born between 23-35 weeks gestational age (GA)
- have reached 31-32 weeks post menstrual age (PMA)
- clinically stable
- male or female
- could be receiving oxygen or intravenous therapy
Key exclusion criteria (12 listed)
- major brain injuries (e.g. cystic PVL)
- current sepsis
- intubated for mechanical ventilation at time of enrollment
- surgical necrotizing enterocolitis
- Ward of the State
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 |
|---|---|---|
| H-HOPE InterventionThe H-HOPE intervention (Hospital to Home: Optimizing the Preterm Infant's Environment) to promote early infant development and parental engagement. H-HOPE includes ATVV, which provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation with a parent-directed component which provides participatory guidance and social support to engage with their infants. | Behavioural | H-HOPE Cohort |
Primary outcome
Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation)
Time frame: Every 2 months from Executing through 6 months after supported implementation ends
Change in % of instances of H-HOPE being offered
Aim 1 Outcome Measure: Implementation Success (Change in Reach throughout implementation)
Time frame: Every 2 months from Executing through 6 months after supported implementation ends
% of eligible parent-infant units receiving H-HOPE
Aim 1 Outcome Measure: Implementation Success (Degree of Implementation)
Time frame: Every 2 months from Executing through 6 months after supported implementation ends
In-Hospital: Infant: Mean number of ATVV interventions received per eligible day (Range 0-2) Transition to home: Parents: # received participatory guidance sessions (2 pre-discharge and 2 screen time visits at 2-3 days and 7-15 days post-discharge; Range: 0-3) Infant: Mean number of ATVV interventions received by per eligible day since discharge (Range 0-2; provided and reported by parent)
Aim 2 Outcome Measure: Effectiveness-(Change in Infant Head Circumference)
Time frame: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Infant Primary: Infant Head Circumference, measured in centimeters.
Aim 2 Outcome Measure: Effectiveness (Change in Infant Weight)
Time frame: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Infant Primary: Weight, measured in kilograms
Aim 2 Outcome Measure: Effectiveness (Change in Infant Length)
Time frame: From birth to discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Infant Primary: Length, measured in centimeters
Aim 2 Outcome Measure: Effectiveness (Change in number of Acute Care Visits)
Time frame: At 6 weeks post discharge
Number of acute care visits (clinic or emergency department visit or re-hospitalization)
2 secondary outcomes
Aim 2 Outcome Measure: Cost
Time frame: From infant enrollment through infant discharge (an average of 31- 48 weeks PMA (Post Menstrual Age) of infant)
Aim 3 Outcome Measure: CFIR influences (Number of facilitators and barriers to implementation)
Time frame: From the completion of the first site's Sustaining Phase through Final Analysis of all site data, estimated to be 39 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 33761902White-Traut R, Brandon D, Kavanaugh K, Gralton K, Pan W, Myers ER, Andrews B, Msall M, Norr KF. Protocol for implementation of an evidence based parentally administered intervention for preterm infants. BMC Pediatr. 2021 Mar 24;21(1):142. doi: 10.1186/s12887-021-02596-1.
- Complete List of Published Work in MyBibliography for Rosemary White-TrautLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rosemary White-Traut, PhD,RN,FAAN principal investigator
Department of Nursing Research and Evidence-Based Practice Children's Wisconsin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-HOPE Intervention in people with Premature Infants and Parent-Child Relations, run by Medical College of Wisconsin at 4 sites 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 13 inclusion and 12 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation) (time frame: Every 2 months from Executing through 6 months after supported implementation ends). The study lists 7 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 NCT04555590, 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 13 Feb 2025.