NCT07372898 · Ann & Robert H Lurie Children's Hospital of Chicago
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
(H-HOPE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Infant pre-feeding behavioral state
Time frame: At completion of intervention period, an average of 4 weeks
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.
Infant pre-feeding behavioral cues
Time frame: At completion of intervention period, an average of 4 weeks
Pre-feeding behavioral cues observed by trained observers in feeding video. Trained observer to record feeding readiness cues observed.
Infant oral feeding progression
Time frame: Through completion of intervention period, an average of 4 weeks
Percent of ordered feeding volume taken by mouth each day of the study
Infant growth
Time frame: Through completion of intervention period, an average of 4 weeks
Measured in grams per day of weight gain .
Infant neuroendocrine function
Time frame: At completion of intervention period, an average of 4 weeks
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
Infant motor development
Time frame: At completion of intervention period, an average of 4 weeks.
Infant score on Test of Infant Motor Performance (TIMP). Raw scores range from 0-142, with higher scores indicative of better motor function.
Infant gross motor, fine motor, communication, problem solving, personal-social neurodevelopment
Time frame: At 3-4 months infant post-menstrual age
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
Infant feeding outcomes at home
Time frame: At 3-4 month infant post-menstrual age
Study specific survey; no numerical score but numbers of feeding problems reported will be used.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations