The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Oral feeding measures
研究概览
简要总结
This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.
详细描述
This project aims to determine the effects of an oral motor stimulation combined with a reading curriculum vs an oral motor stimulation alone vs controls among preterm infants born 23-30 weeks gestation in the NICU. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will start oral feeding at an earlier age, have fewer days to full oral feeding, and fewer days in the NICU compared to infants receiving an oral motor stimulation and controls. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will have increased infant vocalizations, increased conversational turns, increased adult word counts, decreased maternal stress, decreased degree of post-traumatic stress post-discharge, improved receptive and expressive language development at 12 and 24 months, and improved parent reported behavioral outcomes at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician will analyze deidentified data and Bayley assessments will be conducted by blinded psychologists.
入排标准
- 年龄范围
- 23 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •23-30 weeks
- •English and Spanish speaking
排除标准
- •Major congenital anomalies
- •Surgical necrotizing enterocolitis
- •Non-English and Non-Spanish speaking
结局指标
主要结局
Oral feeding measures
时间窗: From date of birth to day of NICU hospital discharge
Days to first oral feeding, days to complete oral feeding, hospital days
次要结局
- Number of adult, infant, and conversational turn word counts measured by LENA device(From enrollment and biweekly until 36 weeks corrected)
- Maternal post traumatic stress disorder(7, 12 and 24 months)
- Child Behavior(24 months)
- Maternal stress(36 weeks corrected)
- Bayley Scales of Infant and Toddler Development, Fourth Edition(12 months and 24 months)
研究者
Julia Mayne
Assistant Professor of Pediatrics
Women and Infants Hospital of Rhode Island