40 Participants Needed

H-HOPE for Birth Defects

(H-HOPE Trial)

SH
SM
Overseen BySteven M Ward, BS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

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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

My infant is under 48 weeks old, stable, on minimal respiratory support, and not on IV pain meds.
My infant needs major surgery for a birth defect.

Exclusion Criteria

My child is under state care.
Infants with a history of Extracorporeal Membrane Oxygenation
My baby was born before 34 weeks of pregnancy.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

H-HOPE intervention is administered, including Parents+ and Massage+ components

4 weeks
Regular reinforcement sessions

ICU Discharge

Outcomes measured at ICU discharge, including infant feeding, growth, and neurodevelopment

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurodevelopmental assessments

3-4 months

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

Group I: H-HOPEExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials
275
Recruited
5,182,000+

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 ...