Hospital-to-home support (H-HOPE) for infants with congenital defects after neonatal surgery and their parents

Impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) Intervention on Infants With Congenital Defects Requiring Neonatal Surgery and Their Parents.

This program tests whether H-HOPE helps infants born with congenital defects who need neonatal surgery — and their parents — improve feeding, growth, early development, and parental mental health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 1 Week to 8 Weeks
• Sex: All
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07372898 on ClinicalTrials.gov

What this trial studies

The study compares the H-HOPE hospital-to-home intervention versus standard ICU care for infants born with congenital defects who require major neonatal surgery and their parents. H-HOPE, previously used in preterm and at-risk infant populations, is delivered while infants are clinically stable and under 48 weeks post-menstrual age, with follow-up at ICU discharge and at 3–4 months. Primary outcomes include pre-feeding behavioral organization, salivary cortisol reactivity, oral feeding progression, growth, and early neurodevelopment measured by tools such as the Test of Infant Motor Performance and Ages and Stages Questionnaire. Secondary outcomes examine parent mental health, parent neuroendocrine measures, parent-infant interactions, and relationships with family living conditions.

Who should consider this trial

Good fit: Ideal participants are infants born with a congenital defect requiring major neonatal surgery (including congenital heart disease) who are clinically stable, under 48 weeks post-menstrual age, not born before 34 weeks gestation, and enrolled together with one or both parents.

Not a fit: Patients unlikely to benefit include infants born before 34 weeks, those with nervous system congenital defects, genetic syndromes, history of ECMO or prolonged mechanical ventilation, wards of the state, or infants who remain clinically unstable or require high respiratory support.

Why it matters

Potential benefit: If successful, H-HOPE could speed feeding progress, support better early motor and behavioral development, and reduce parental depression and anxiety, easing the transition from hospital to home.

How similar studies have performed: H-HOPE has shown benefits for neurodevelopment and feeding in healthy and at-risk term and preterm infants, but it has not been previously tested in infants with congenital defects requiring neonatal surgery.

Eligibility criteria

Inclusion criteria:

* Infants and one or both of their parents, born with a congenital defect and requiring major surgery during the neonatal period, including congenital heart disease.
* At the time of H-HOPE initiation, infants must be \<48 weeks post-menstrual age (PMA), clinically stable (no vital sign instability during routine nursing care) on respiratory support \< a nasal cannula at 2 liters per minute, and off all intravenous (IV) pain medications.

Exclusion criteria:

* Infants born at \<34 weeks gestation,
* Infants born with congenital defects involving the nervous system (i.e., spina bifida, congenital hydrocephalus),
* Infants with genetic syndromes,
* Infants with a history of Extracorporeal Membrane Oxygenation,
* Infants with a history of mechanical ventilation lasting 30 or more days, or
* Infants that are wards of the state.

Where this trial is running

Chicago, Illinois

• Ann & Robert H Lurie Children's Hospital — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Susan Horner, PhD — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Susan Horner, PhD

Conditions: Oral Feeding Outcomes, Neurodevelopment Outcome, H-HOPE, Infant, Surgical, Congenital defect, Neonatal intensive care