Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)

NCT07372898 | Recruiting

• 1 other identifier: STUDY00000204
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Feeding Outcomes; Neurodevelopment Outcome

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Infant pre-feeding behavioral state

  Pre-feeding state observed by trained observers in feeding video. One pre-feeding behavioral state will be assigned using the following scale 1) Quiet sleep, 2) Active sleep, 3) Drowsy, 4) Quiet alert, 5) Active alert, or 6) Crying.

  At completion of intervention period, an average of 4 weeks

• Infant pre-feeding behavioral cues

  Pre-feeding behavioral cues observed by trained observers in feeding video. Trained observer to record feeding readiness cues observed.

  At completion of intervention period, an average of 4 weeks

• Infant oral feeding progression

  Percent of ordered feeding volume taken by mouth each day of the study

  Through completion of intervention period, an average of 4 weeks

• Infant growth

  Measured in grams per day of weight gain .

  Through completion of intervention period, an average of 4 weeks

• Infant neuroendocrine function

  Infant salivary cortisol reactivity, measured immediately prior to and after receiving Massage+ with enrolled parent, or being held for 15 minutes by parent if in control group

  At completion of intervention period, an average of 4 weeks

• Infant motor development

  Infant score on Test of Infant Motor Performance (TIMP). Raw scores range from 0-142, with higher scores indicative of better motor function.

  At completion of intervention period, an average of 4 weeks.

• Infant gross motor, fine motor, communication, problem solving, personal-social neurodevelopment

  Infant score on Ages and Stages-3 for 3-4 month old infant; Scores range from 0-300 with higher scores indicative of better neurodevelopment

  At 3-4 months infant post-menstrual age

• Infant feeding outcomes at home

  Study specific survey; no numerical score but numbers of feeding problems reported will be used.

  At 3-4 month infant post-menstrual age

Secondary Outcomes (7)

• Parental perinatal depression

  At completion of the intervention period, an average of 4 weeks

• Parental anxiety

  At completion of intervention period, an average of 4 weeks

• Parenting confidence

  At completion of intervention period, an average of 4 weeks

• Perinatal post-traumatic distress syndrome

  At 3-4 months infant postmenstrual age.

• Parental salivary cortisol reactivity

  At completion of intervention period, an average of 4 weeks

Study Arms (2)

H-HOPE

EXPERIMENTAL

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.

Behavioral: H-HOPE

Control

NO INTERVENTION

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 BEHAVIORAL

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.

H-HOPE

Eligibility Criteria

• Age: 1 Week - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (2)

• White-Traut R, Gralton K, Schmitt M, Brandon D, Kavanaugh K, Norr KF. Parents+: An Early Behavioral Intervention as a Pathway for Parent-Partnered Care. Adv Neonatal Care. 2025 Oct 1;25(5):432-440. doi: 10.1097/ANC.0000000000001288. Epub 2025 Sep 23.

  PMID: 41020674 BACKGROUND

• White-Traut R, Brandon D, Kavanaugh K, Gralton K, Pan W, Myers ER, Andrews B, Msall M, Norr KF. Protocol for implementation of an evidence based parentally administered intervention for preterm infants. BMC Pediatr. 2021 Mar 24;21(1):142. doi: 10.1186/s12887-021-02596-1.

  PMID: 33761902 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Susan Horner, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Horner, PhD

CONTACT

16309158541; shorner@luriechildrens.org

Steven M Ward, BS

CONTACT

312.227-5064; smward@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Model Details: Conceptual model: H-HOPE and Parent-Infant Outcomes Challenges faced by parents and their infants born with a congenital defect can be addressed via interventions that target early relational health. Pre-existing parental and infant biologic and social factors are known to influence the infant, parent, and parent-infant relationship. The H-HOPE intervention improves infant behavior, feeding, growth, and neurodevelopment. Mothers providing Massage+, included in the H-HOPE intervention, for their infants, report improved mental health and parenting confidence. Additionally, mothers and infants have improved neuroendocrine function, which may improve mother-infant interaction and neurodevelopment.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: January 28, 2026
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)