Recruiting

H-HOPE

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT07372898

Conditions

Oral Feeding Outcomes

Neurodevelopment Outcome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

H-HOPE

Study Details

Brief summary:

Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments. Additionally, their parents are at higher risk for adverse mental health outcomes.

Early relationships are essential to healthy growth and development in all children. Relationships between parents and infants born with a congenital defect are negatively impacted by separation due to hospitalization; parental and infant stress exposures; and alterations in infant behavior and parental mental health. Benefits of H-HOPE intervention on infant neurodevelopment outcomes have been observed in healthy and at-risk term and preterm infant populations but never evaluated in infants with congenital defects. The purpose of this study is to examine impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention versus standard ICU care for infants born with a congenital defect requiring neonatal surgery, and their parents. The main questions to be answered include:

1. Does H-HOPE improve pre-feeding state and behavior, oral feeding progression, and growth in infants born with a congenital defect requiring neonatal surgery?
2. Does H-HOPE neurodevelopmental outcomes in infants born with a congenital defect requiring neonatal surgery?
3. Does H-HOPE improve parental mental health outcomes among parents of infants born with a congenital defect requiring neonatal surgery?
4. Does H-HOPE improve parent-infant interactions among infants born with a congenital defect requiring neonatal surgery and their parents?
5. Does H-HOPE improve neuroendocrine function among infants born with a congenital defect requiring neonatal surgery and their parents?
6. Do parents of infants born with congenital defects requiring surgery experience participating in the H-HOPE intervention positively?

Results of this study may provide preliminary evidence supporting use of H-HOPE to positively impact short- and long-term outcomes for these infants and their parents.

Conditions

Oral Feeding Outcomes

Neurodevelopment Outcome

Study ID

NCT07372898

Start date

Jul 31, 2025

Status verified date

Jan, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: H-HOPE

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.

no intervention: Control

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.

Interventions

H-HOPE

The H-HOPE (Hospital to Home: Optimizing Preterm Infant Environment) intervention is a multisensory behavioral intervention. H-HOPE has two components: Parents+ and Massage+ (see Training Manual in Documents).

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 that will be taught to parents during Parents+ sessions and implemented by parents with infants in the experimental group. 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). Trained staff may provide Massage+ when parents are not available.

Primary outcome measure

  • Infant pre-feeding behavioral state [ Time Frame: At completion of intervention period, an average of 4 weeks ]
  • Infant pre-feeding behavioral cues [ Time Frame: At completion of intervention period, an average of 4 weeks ]
  • Infant oral feeding progression [ Time Frame: Through completion of intervention period, an average of 4 weeks ]
  • Infant growth [ Time Frame: Through completion of intervention period, an average of 4 weeks ]
  • Infant neuroendocrine function [ Time Frame: At completion of intervention period, an average of 4 weeks ]
  • Infant motor development [ Time Frame: At completion of intervention period, an average of 4 weeks. ]
  • Infant gross motor, fine motor, communication, problem solving, personal-social neurodevelopment [ Time Frame: At 3-4 months infant post-menstrual age ]
  • Infant feeding outcomes at home [ Time Frame: At 3-4 month infant post-menstrual age ]

Central Contacts and Locations

Central contacts

Susan Horner, PhD

16309158541shorner@luriechildrens.org

Steven M Ward, BS

312.227-5064smward@luriechildrens.org

Locations

Ann & Robert H Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Susan Horner, PhD

16309158541shorner@luriechildrens.org

Steven M Ward, BS

smward@luriechildrens.org

Principal Investigator:

Susan Horner, PhD

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • H-HOPE
  • Infant
  • Surgical
  • Congenital defect
  • Neonatal intensive care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-01-28.