H-HOPE Intervention for Premature Infants

Recruiting at 3 trial locations

Overseen By Rosemary White-Traut, PhD,RN,FAAN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Major brain injuries, Sepsis, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1882 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether participants need to stop taking their current medications. However, since the trial focuses on behavioral interventions for infants and their parents, it is unlikely that stopping medications is required. Please consult with the trial coordinators for more specific guidance.

What data supports the idea that H-HOPE Intervention for Premature Infants is an effective treatment?

The available research shows that the H-HOPE Intervention is effective because it is a standardized program that includes both infant-directed and parent-directed components. It has been documented to help with feeding, growth, and development in premature infants. The study aims to make H-HOPE the standard care in multiple neonatal intensive care units, indicating its recognized benefits. Compared to other treatments, H-HOPE focuses on both the infant's needs and parental involvement, which is not commonly provided as routine care in many hospitals. ^{1 2 3 4 5}

What safety data is available for the H-HOPE Intervention for premature infants?

The provided research does not directly address safety data for the H-HOPE Intervention. However, it mentions that H-HOPE is a standardized behavioral intervention with documented efficacy, suggesting it has been studied for effectiveness. The research also highlights the need for safety monitoring in NICUs, but specific safety data for H-HOPE is not detailed in the abstracts. ^{1 6 7 8 9}

Is the H-HOPE Intervention a promising treatment for premature infants?

Yes, the H-HOPE Intervention is promising for premature infants. It helps improve feeding, growth, and development, and enhances mother-infant interactions. It also increases the frequency of behaviors that prepare infants for feeding and keeps them more alert, which is important for their development. ^{1 2 10 11 12}

What is the purpose of this trial?

This trial tests the H-HOPE program, which helps preterm infants develop through sensory stimulation and supports parents in interacting with their babies. The study aims to see if H-HOPE can be successfully used in different NICUs and if it improves infant health and reduces costs. The results could lead to widespread use of H-HOPE in hospitals. H-HOPE is a standardized behavioral intervention with an infant-directed component designed to optimize developmental trajectories and increase parents' interactive engagement with their infants.

Research Team

Rosemary White-Traut, PhD,RN,FAAN

Principal Investigator

Department of Nursing Research and Evidence-Based Practice Children's Wisconsin

Eligibility Criteria

This trial is for preterm infants born between 23-35 weeks gestational age, now at 31-32 weeks post menstrual age, and their parents. Infants may be on oxygen or IV therapy and previously intubated but must be ready for social interaction. Parents of any background can join; only one infant per multiple births will be analyzed.

Inclusion Criteria

I am either male or female.

The study is looking at two groups of parents and infants: one group is receiving a family intervention called H-HOPE, and the other group is a comparison group. Both parents and infants must meet certain requirements to be eligible for either group. There are also requirements for hospital personnel involved in the study.

I may be on oxygen or receiving treatment through an IV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

H-HOPE intervention is implemented in NICUs, including Planning and Engaging, Executing, and Reflecting and Evaluating steps

6 months

Regular NICU visits for implementation activities

Sustaining

Sustaining phase to ensure continued offering of H-HOPE and measure implementation success

6 months

Follow-up

Participants are monitored for effectiveness and safety, including infant growth and acute care visits

6 weeks post-discharge

Treatment Details

Interventions

• H-HOPE Intervention

Trial Overview The H-HOPE Intervention is being tested to see if it can support early brain development in premature infants by providing stimulation (auditory, tactile, visual, vestibular) and helping parents engage with their babies in NICUs and at home.

Participant Groups

Group I: H-HOPE Cohort Experimental Treatment 1 Intervention

The H-HOPE Cohort will receive the H-HOPE intervention.

Group II: Pre H-HOPE Cohort Active Control 1 Intervention

The Pre-H-HOPE Comparison Cohort will not receive the H-HOPE intervention, and represents the prior standard (non-HOPE).

H-HOPE Intervention is already approved in United States for the following indications:

Approved in United States as H-HOPE Intervention for:

• Supporting early brain maturation, health, and development in preterm infants

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Children's Hospital and Health System Foundation, Wisconsin

Collaborator

Trials

56

Recruited

93,300+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Advocate Health Care

Collaborator

Trials

57

Recruited

1,412,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Advocate Aurora Health

Collaborator

Trials

3

Recruited

57,000+

Findings from Research

The H-HOPE intervention, which includes both infant-directed and parent-directed components, aims to standardize behavioral care for preterm infants across five NICUs, potentially improving feeding, growth, and developmental outcomes.

This implementation study uses a structured approach based on the Consolidated Framework for Implementation Research (CFIR) to identify facilitators and barriers to successfully integrating H-HOPE into routine care, with the goal of sustaining its use even after external support ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for implementation of an evidence based parentally administered intervention for preterm infants. White-Traut, R., Brandon, D., Kavanaugh, K., et al.[2023]

A study involving 284 very preterm infants assessed the effectiveness of a home-based developmental education intervention, but by age 5, there were no significant differences in cognitive, behavioral, or motor outcomes among the intervention groups compared to standard care.

Despite some initial advantages observed at 2 years, the benefits of early intervention did not persist by age 5, raising questions about the long-term efficacy of such programs for improving outcomes in very preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of parental support for families with very preterm children: outcome at 5 years. Johnson, S., Ring, W., Anderson, P., et al.[2019]

The article explores the concept of hope specifically in parents of critically ill newborns in neonatal intensive care units, highlighting its significance in this challenging context.

It aims to define critical attributes of hope, as well as its antecedents and consequences, providing a comprehensive understanding of how hope functions for these parents during a difficult time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hope and parents of the critically ill newborn: a concept analysis. Amendolia, B.[2022]

Reducing stress and responding to behavioral cues in the NICU can significantly improve developmental outcomes for premature infants.

Implementing proactive developmental surveillance and early intervention services from the NICU through outpatient care is believed to enhance the overall development of these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental and Interprofessional Care of the Preterm Infant: Neonatal Intensive Care Unit Through High-Risk Infant Follow-up. Lipner, HS., Huron, RF.[2019]

The study found that using recorded home oximetry (RHO) data allowed for a significant reduction in the duration of home oxygen therapy (HOT) for premature infants, with an average discontinuation time of 78.1 days compared to 100.1 days in the standard-care group.

Both groups reported improved quality of life after discontinuing HOT, indicating that RHO not only helps in managing oxygen therapy more effectively but also supports the well-being of families, without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transmitted Home Oximetry and Duration of Home Oxygen in Premature Infants. Rhein, L., White, H., Simoneau, T., et al.[2020]

A study in a level IV NICU identified and quantified preventable harm events, with unscheduled extubations and intravenous infiltrates being the most common occurrences, highlighting critical areas for safety improvement.

The Neonatal Preventable Harm Index was developed as a new tool to monitor and address serious safety events in the NICU, although no significant trends in event rates were found during the study period from March 2013 to January 2015.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neonatal preventable harm index: a high reliability tool. Murphy, T., Bender, J., Taub, M., et al.[2018]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

Preterm infants receiving hospital-assisted neonatal home care showed a 61% lower risk of developmental delays at 2 years compared to those receiving standard hospital care, indicating better neurodevelopmental outcomes.

Home care also resulted in shorter hospital stays by an average of 9 days, higher rates of breastmilk feeding at discharge, and fewer readmissions before 1 year, highlighting its efficacy in supporting both health and nutrition for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early discharge and hospital-assisted home care is associated with better neurodevelopmental outcome in preterm infants. Losbar, JL., Montjaux, N., Ehlinger, V., et al.[2022]

The SPEEDI intervention, which supports preterm infants transitioning from the NICU to home, was found to be feasible, with infants receiving nearly all planned interventions (96.4% in NICU and 100.3% at home).

Despite the high intervention frequency, only 28% of infants were receiving early intervention services during the SPEEDI period, indicating a potential gap in service utilization that could be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Play Exploration and Early Development Intervention From NICU to Home: A Feasibility Study. Dusing, SC., Brown, SE., Van Drew, CM., et al.[2019]

The H-HOPE intervention, which included infant stimulation and maternal guidance, significantly improved mother-infant interaction patterns in a study of 198 premature infants born at 29-34 weeks gestation, as measured by higher NCAST and DMC scores at 6 weeks corrected age.

Mothers and infants in the H-HOPE group showed increased responsiveness during play and better overall interaction, suggesting that targeted interventions can enhance developmental outcomes for premature infants and their mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mother-infant interaction improves with a developmental intervention for mother-preterm infant dyads. White-Traut, R., Norr, KF., Fabiyi, C., et al.[2022]

The Family Nurture Intervention (FNI) was safely and feasibly implemented in a high-acuity NICU, involving 150 infants and their families, but did not significantly affect the length of stay in the NICU, which was the primary outcome measure.

Despite the lack of impact on the primary outcome, the study suggests that FNI can be integrated into NICU care without increasing medical complications, indicating its potential for future research on long-term neurodevelopmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. Welch, MG., Hofer, MA., Stark, RI., et al.[2021]

The integrated H-HOPE intervention significantly increased the frequency of orally directed behaviors in preterm infants (born at 29-34 weeks gestation) compared to the Attention Control group, indicating improved readiness for oral feeding.

On Day 7, the H-HOPE group also showed a higher proportion of time spent in an alert behavioral state during and immediately after the intervention, suggesting that this approach may enhance behavioral organization in clinically stable preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preterm infants' orally directed behaviors and behavioral state responses to the integrated H-HOPE intervention. White-Traut, R., Rankin, KM., Pham, T., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Protocol for implementation of an evidence based parentally administered intervention for preterm infants. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Randomised trial of parental support for families with very preterm children: outcome at 5 years. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Hope and parents of the critically ill newborn: a concept analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Developmental and Interprofessional Care of the Preterm Infant: Neonatal Intensive Care Unit Through High-Risk Infant Follow-up. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Transmitted Home Oximetry and Duration of Home Oxygen in Premature Infants. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The neonatal preventable harm index: a high reliability tool. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Early discharge and hospital-assisted home care is associated with better neurodevelopmental outcome in preterm infants. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Supporting Play Exploration and Early Development Intervention From NICU to Home: A Feasibility Study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Mother-infant interaction improves with a developmental intervention for mother-preterm infant dyads. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Preterm infants' orally directed behaviors and behavioral state responses to the integrated H-HOPE intervention. [2022]