H-HOPE Intervention for Premature Infants
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Medical College of Wisconsin
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345What 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.
16789Is 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.
12101112Eligibility 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.
+7 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: H-HOPE CohortExperimental Treatment1 Intervention
The H-HOPE Cohort will receive the H-HOPE intervention.
Group II: Pre H-HOPE CohortActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
Duke UnivesityDurham, NC
Children's Hospital of WisconsinMilwaukee, WI
Advocate Aurora HealthPark Ridge, IL
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
Children's Hospital and Health System Foundation, WisconsinCollaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
Duke UniversityCollaborator
University of ChicagoCollaborator
Advocate Health CareCollaborator
Wake Forest University Health SciencesCollaborator
Advocate Aurora HealthCollaborator
References
Protocol for implementation of an evidence based parentally administered intervention for preterm infants. [2023]Multi-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents' interactive engagement with their infants. However, few neonatal intensive care units (NICUs) provide evidence-based standardized early behavioral interventions as routine care. Lack of implementation is a major gap between research and clinical practice. H-HOPE, is a standardized behavioral intervention with an infant- directed component (Massage+) and a parent-directed component (four participatory guidance sessions that focus on preterm infants' behaviors and appropriate responses). H-HOPE has well documented efficacy. The purpose of this implementation study is to establish H-HOPE as the standard of care in 5 NICUs.
Randomised trial of parental support for families with very preterm children: outcome at 5 years. [2019]To test the effectiveness of a home based developmental education intervention in improving outcome at 5 years for very preterm infants.
Hope and parents of the critically ill newborn: a concept analysis. [2022]Hope is a human phenomenon that is observed repeatedly in the neonatal intensive care unit setting. There have been few studies specifically examining the concept of hope in this population. The purpose of this article is to examine the concept of hope in parents of critically ill newborns. Uses of the concept will be investigated. Critical defining attributes will be provided. Antecedents and consequences of hope will be investigated. An overview of the empirical referents of hope will be presented.
Developmental and Interprofessional Care of the Preterm Infant: Neonatal Intensive Care Unit Through High-Risk Infant Follow-up. [2019]Practices in the neonatal intensive care unit (NICU) that reduce infant stress and respond to behavioral cues positively influence developmental outcomes. Proactive developmental surveillance and timely introduction of early intervention services improve outcomes for premature infants. A model that emphasizes infant development and a continuum of care beginning in the NICU with transition to outpatient monitoring and provision of early intervention services is hypothesized to support the most optimal outcomes for premature infants.
Transmitted Home Oximetry and Duration of Home Oxygen in Premature Infants. [2020]To determine if a home oxygen therapy (HOT) management strategy that includes analysis of recorded home oximetry (RHO) data, compared with standard monthly clinic visit assessments, reduces duration of HOT without harm in premature infants.
The neonatal preventable harm index: a high reliability tool. [2018]The aim of this study is to identify, quantify and disseminate a novel set of safety indicators for monitoring the occurrence of preventable harm in the neonatal intensive care unit (NICU).
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]Currently there are few practical methods to identify and measure harm to hospitalized children. Patients in NICUs are at high risk and warrant a detailed assessment of harm to guide patient safety efforts. The purpose of this work was to develop a NICU-focused tool for adverse event detection and to describe the incidence of adverse events in NICUs identified by this tool.
Early discharge and hospital-assisted home care is associated with better neurodevelopmental outcome in preterm infants. [2022]To compare hospital-assisted neonatal home care and standard hospital care for preterm newborns on neurodevelopment at 2 years corrected age, as well as duration of hospitalization, breastmilk rates, and readmissions before 1 year.
Supporting Play Exploration and Early Development Intervention From NICU to Home: A Feasibility Study. [2019]To determine the feasibility of completing a clinical trial of Supporting Play Exploration and Early Development Intervention (SPEEDI) that blends early and intense intervention with family support during the transition from the neonatal intensive care unit (NICU) to home and the community.
Mother-infant interaction improves with a developmental intervention for mother-preterm infant dyads. [2022]While premature infants have a high need for positive interactions, both infants and their mothers are challenged by the infant's biological immaturity. This randomized clinical trial of 198 premature infants born at 29-34 weeks gestation and their mothers examined the impact of the H-HOPE (Hospital to Home: Optimizing the Infant's Environment) intervention on mother-premature infant interaction patterns at 6-weeks corrected age (CA). Mothers had at least 2 social environmental risk factors such as minority status or less than high school education. Mother-infant dyads were randomly assigned to the H-HOPE intervention group or an attention control group. H-HOPE is an integrated intervention that included (1) twice-daily infant stimulation using the ATVV (auditory, tactile, visual, and vestibular-rocking stimulation) and (2) four maternal participatory guidance sessions plus two telephone calls by a nurse-community advocate team. Mother-infant interaction was assessed at 6-weeks CA using the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST, 76 items) and the Dyadic Mutuality Code (DMC, 6-item contingency scale during a 5-min play session). NCAST and DMC scores for the Control and H-HOPE groups were compared using t-tests, chi-square tests and multivariable analysis. Compared with the Control group (n = 76), the H-HOPE group (n = 66) had higher overall NCAST scores and higher maternal Social-Emotional Growth Fostering Subscale scores. The H-HOPE group also had significantly higher scores for the overall infant subscale and the Infant Clarity of Cues Subscale (p
Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. [2021]While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). Here, we report the first trial results, including the primary outcome measure, length of stay in the NICU and, the feasibility and safety of its implementation in a high acuity level IV NICU.
Preterm infants' orally directed behaviors and behavioral state responses to the integrated H-HOPE intervention. [2022]Preterm infants are challenged by immature infant behavioral organization which may negatively influence their ability to oral feed. The purpose of this study was to determine whether the integrated H-HOPE (Hospital to Home: Optimizing the Infant's Environment) intervention would improve infant behavioral organization by increasing the frequency of orally directed behaviors and the proportion of time spent in an alert behavioral state when offered prior to oral feeding. Mother-infant dyads (n=198) were randomly assigned to the H-HOPE intervention or the Attention Control groups. Infants were born at 29-34 weeks gestation and were clinically stable. Mothers had at least two social environmental risk factors such as minority status or less than high school education. H-HOPE is an integrated intervention that included (1) twice-daily infant directed stimulation using the ATVV intervention (auditory, tactile, visual, and vestibular stimuli) and (2) maternal participatory guidance sessions by a nurse-community advocate team. Orally directed behaviors and behavioral states were assessed weekly prior to feeding during hospitalization when infants were able to feed orally. There were no differences between the groups at baseline (Day 0, prior to the initiation of the integrated H-HOPE intervention). We observed a pattern of increased frequency of orally directed behaviors in the H-HOPE intervention group when compared to the Attention Control group, however, the proportion of time spent in an alert behavioral state remained stable in both groups over the course of the study. On Day 7, the H-HOPE intervention group exhibited a significantly higher mean frequency of orally directed behaviors than the Attention Control group (12.6 vs. 7.1 pre-intervention, 51.8 vs. 33.2 during intervention, 4.3 vs. 3.2 immediately after intervention, and 8.9 vs. 5.3 immediately prior to feeding). On Day 7, the H-HOPE intervention group exhibited a significantly higher proportion of time spent in an alert behavioral state only during intervention (0.26 vs. 0.11) and immediately after intervention (0.28 vs. 0.06). These findings are suggestive that the integrated H-HOPE intervention facilitated infant behavioral organization for clinically stable infants born between 29 and 34 weeks gestation. The orally directed behaviors appear to be an important indicator of the infant's preparation for feeding, and when used in conjunction with assessment of behavioral states, are especially valuable to the clinician. Use of this combined assessment approach in practice would strengthen clinician assessment for initiation of (beginning the first oral feeding) and daily preparation for oral feeding in preterm infants.