H-HOPE for Birth Defects
(H-HOPE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a special program called H-HOPE, designed to assist infants born with congenital defects who require surgery shortly after birth. The goal is to determine if this program improves infant feeding, growth, and development, as well as the mental health of their parents. The trial compares the H-HOPE program, which involves parents learning to interact with and massage their babies, with standard hospital care. Families with infants needing neonatal surgery for congenital defects, who are stable and on minimal respiratory support, may be suitable for this study. As an unphased trial, it offers families the chance to contribute to innovative care strategies that could enhance outcomes for both infants and parents.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. However, infants must be off all intravenous (IV) pain medications to participate.
What prior data suggests that the H-HOPE intervention is safe for infants with congenital defects?
Research has shown that the H-HOPE program is generally well-received by both infants and their parents. In past studies, H-HOPE helped infants grow and develop better, without major safety issues. One study found that infants who participated in H-HOPE had better health compared to those who did not. Parents also provided positive feedback about their experience with the program.
The H-HOPE program includes activities like gentle massage and talking to the baby, which are easy and non-invasive. This approach supports both infants and parents during a difficult time. Overall, evidence suggests that H-HOPE is a safe way to improve the health and well-being of infants with congenital defects and their families.12345Why are researchers excited about this trial?
Researchers are excited about the H-HOPE intervention for preterm infants because it offers a unique, multisensory approach that empowers parents to actively engage in their baby's development. Unlike standard care options that primarily rely on professional interventions, H-HOPE includes parent-led components like Parents+ and Massage+, teaching parents to interpret and respond to their infant’s cues. This approach not only fosters bonding but also potentially enhances the infant's sensory and neurological development through regular, personalized interaction. By involving parents directly, H-HOPE aims to improve developmental outcomes in a way that is both hands-on and nurturing.
What evidence suggests that the H-HOPE intervention is effective for infants with congenital defects?
Research has shown that the H-HOPE program, which participants in this trial may receive, offers promising benefits for babies, particularly those born early or at risk. Studies have found that H-HOPE helps babies gain weight and grow better from birth until hospital discharge. It also supports their development and strengthens the bond between mothers and their babies. Parents have reported better experiences, and hospitals have saved money with H-HOPE. While these benefits have been observed in both healthy and at-risk babies, this trial specifically examines its effects on babies with birth defects.13456
Who Is on the Research Team?
Susan Horner, PhD
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Are You a Good Fit for This Trial?
This trial is for infants born with congenital defects requiring neonatal surgery and their parents. It aims to evaluate the H-HOPE intervention's effect on infant development, feeding, growth, neuroendocrine function, and parental mental health compared to standard ICU care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
H-HOPE intervention is administered, including Parents+ and Massage+ components
ICU Discharge
Outcomes measured at ICU discharge, including infant feeding, growth, and neurodevelopment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neurodevelopmental assessments
What Are the Treatments Tested in This Trial?
Interventions
- H-HOPE
Trial Overview
The study tests the H-HOPE program designed to optimize the environment for preterm surgical neonates at home versus standard care. It looks into how this approach might benefit infant development, parent-infant interactions, and reduce stress for both parties.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The H-HOPE (Hospital to Home: Optimizing Preterm Infant Environment) intervention is a multisensory behavioral intervention. H-HOPE has two components: Parents+ and Massage+. Parents+: Trained study team members will provide Parents+ training using participatory guidance and experiential learning approaches. During the Parents+ sessions, parents learn infant behavioral cues, and how to read, interpret, and respond to their infant's cues during Massage+. They also learn the Massage+ intervention. Massage+ is a 15-minute, multisensory, behavioral intervention taught during Parents+ sessions and implemented by parents with infants in the intervention group 2x/day. It includes talking to the baby (30 seconds), massaging the baby (10 minutes; may be adapted to avoid wounds or as tolerated by baby), visual and vestibular stimuli (rocking and showing face for 5 minutes). Parent training will be reinforced regularly.
Control group infants will receive ICU standard care that may include nursing care every 1-4 hours, developmental or rehabilitative therapies, parent presence, parental holding, skin-to-skin care, or other forms of infant massage. Control group parents will be offered an infant care class unrelated to the study that will include information about infant vision and hearing, sleep, and movement. Professional staff will be educated to not provide Massage+ for Control group infants. This will be reinforced with the staff and monitored daily for each patient enrolled.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
Citations
Influence of H-HOPE Intervention for Premature Infants ... - PMC
Conclusions. For healthy preterm infants, the H-HOPE intervention appears to improve weight gain and length over time from birth to hospital discharge.
Study Details | NCT04555590 | Implementation of an ...
In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute ...
Impact of an integrated mother-preterm infant intervention ...
Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of ...
Parents' Experiences with an Early Behavioral Intervention, H ...
A prior randomized controlled trial of H-HOPE yielded improved infant outcomes ... Impact of an integrated mother-preterm infant intervention on birth ...
Mother–infant interaction improves with a developmental ...
The H-HOPE intervention had a positive impact on mother–infant interaction during both feeding and play. •. H-HOPE provides a model that should be considered as ...
Impact of Hospital to Home: Optimizing Preterm Infant ...
Having received H-HOPE intervention, parents of infants born with a congenital defect will have more favorable outcomes, including: H2.1 ...
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