Impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) Intervention on Infants With Congenital Defects Requiring Neonatal Surgery and Their Parents.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Infant pre-feeding behavioral state
研究概览
简要总结
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:
- Does H-HOPE improve pre-feeding state and behavior, oral feeding progression, and growth in infants born with a congenital defect requiring neonatal surgery?
- Does H-HOPE neurodevelopmental outcomes in infants born with a congenital defect requiring neonatal surgery?
- Does H-HOPE improve parental mental health outcomes among parents of infants born with a congenital defect requiring neonatal surgery?
- Does H-HOPE improve parent-infant interactions among infants born with a congenital defect requiring neonatal surgery and their parents?
- Does H-HOPE improve neuroendocrine function among infants born with a congenital defect requiring neonatal surgery and their parents?
- 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.
详细描述
Primary Objectives: Primary objective of this study is to examine impact of H-HOPE intervention versus standard ICU care on early feeding, growth and neurodevelopment for infants born with a congenital defect requiring major surgery. Hypotheses include:
H1. Infants born with a congenital defect and receiving H-HOPE intervention versus standard care will have more favorable outcomes at ICU discharge and at 3-4 months including:
H1.1 Improved behavioral organization, measured by pre-feeding state and behavioral cues.
H1.2 Improved neuroendocrine function measured by salivary cortisol reactivity. H1.3 More rapid oral feeding progression and growth. H1.4 Improved neurodevelopment, measured by Test of Infant Motor Performance, Ages and Stages Questionnaire, and Parent Report of Oral Feeding at Home survey.
Secondary Objectives: Secondary objectives of study are to evaluate impact of H-HOPE intervention on parents' mental health, parents' neuroendocrine outcomes at ICU discharge, and parent-infant interactions among parents of infants born with a congenital defect requiring surgery. Secondary objectives include exploring potential relationships between parental living conditions and parent-infant outcomes related to H-HOPE. Hypotheses include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: H-HOPE (Behavioral)
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.
结局指标
主要结局
Infant pre-feeding behavioral state
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through completion of intervention period, an average of 4 weeks
Measured in grams per day of weight gain .
Infant neuroendocrine function
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At 3-4 month infant post-menstrual age
Study specific survey; no numerical score but numbers of feeding problems reported will be used.
次要结局
- 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)
- Parental perinatal depression(At completion of the intervention period, an average of 4 weeks)
- Parent-infant interactions during feeding(At completion of intervention period, an average of 4 weeks)
- Qualitative description of H-HOPE impact on parents' relationship with their infant.(At completion of intervention period, an average of 4 weeks through 4 months infant postmenstrual age)
研究者
Susan Horner, PhD
Nurse Scientist
Ann & Robert H Lurie Children's Hospital of Chicago