Effects of Reading to Preterm Infants on Baby and Parents' Well Being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Percent of Oxygen Saturation Measurements <85%
研究概览
简要总结
Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. The investigators will follow rates of common preterm health issues while in the hospital and time to hospital discharge. Effects of bedside reading on parental stress and infant bonding will be measured and compared to usual rates of these indicators to determine if reading to babies reduces stress and enhances bonding.
详细描述
The NICU at Georgetown University Hospital cares for approximately 100 infants per year in the study population between 26-34 weeks gestation. We have a patient population where parental daily visits are the norm, allowing for a study using live voices.
The investigators will approach parents of infants who meet entry criteria who are nearing one week of age after consultation with the clinical care team to determine stability. All preterm infants admitted to the NICU who are deemed stable enough to participate by the primary team will be approached for study participation.
After parental consent is obtained, the parents will be given an initial questionnaire to assess demographic data such as parental education and attitudes regarding reading to infants. Parents will be given a picture book with rhythmic sound patterns for reading aloud to their infant. Bedside nurses will help guide parents to the best time for infant reading. Time of parent reading (start and stop time) will be recorded in the infant's chart. Mothers and fathers will be allowed to read to the infant at separate reading times. A decibel monitor placed at the opening of the incubator will display the decibel level of parental voice.
Parents will be asked to read to their babies for at least 15 minutes but not more than 60 minutes per session. The total reading time for any 24 hour period can be up to 90 minutes.
Reading will occur with the infant in an incubator, in an open warmer or crib or while being held by parents. If the infant is in an incubator, parents will read with the portal closest to the parent open. For those babies who are in an open crib or warmer the parents will read close enough to the bedside so as not to be heard by neighboring patients. In older infants who are stable enough for kangaroo care or are out of bed being held by parents, reading can occur at those times, if desired by the parents. The Infant's location (in incubator, open bed, kangaroo care or parental holding) will be recorded in a study bedside binder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks.
- •Infants at least 7 days of life to allow for transition to extrauterine life.
- •Parental Inclusion Criteria
- •Agreement to the study with signed Informed Consent Form and HIPAA Authorization
- •Visits on a regular basis (at least 3 times per week)
- •Is literate (able to read)
排除标准
- •Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team,
- •infants with congenital hearing loss,
- •chromosomal abnormalities,
- •infants not expected to survive.
- •Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)
结局指标
主要结局
Percent of Oxygen Saturation Measurements <85%
时间窗: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks
Percent of measured oxygen saturations recorded as less than 85%
次要结局
未报告次要终点
研究者
Melissa Scala
Assistant Professor of Pediatrics
Georgetown University