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.
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.
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,
Parallel
H-HOPE
BehavioralThe 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.
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.
Infant pre-feeding behavioral cues
Pre-feeding behavioral cues observed by trained observers in feeding video. Trained observer to record feeding readiness cues observed.
Infant oral feeding progression
Percent of ordered feeding volume taken by mouth each day of the study
Infant growth
Measured in grams per day of weight gain .
Parental perinatal depression
Perinatal depression measured using the Center for Epidemiologic Studies Depression Scale (CES-D); scores 0-60; higher score indicates more perinatal depression
Parental anxiety
Parental anxiety measured using the Child Health Worry Scale; scores 5-25; higher scale indicates more worry or anxiety about child health
Parenting confidence
Parental confidence as measured using the Karitane Parenting Confidence Scale; scores 0-45; higher scores indicate higher parental confidence.
Perinatal post-traumatic distress syndrome
Score on Perinatal Post-Traumatic Stress Disorder Questionnaire-II (PPQ-II) survey; possible scores 0-13; higher score indicates increase in Perinatal PTSD
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