Multisensory Early Oral Administration of Human Milk in Preterm Infants to Attenuate Early Life Toxic Stress on Epigenetic Modifications and Dysbiosis: Randomized Controlled Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
研究概览
简要总结
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation. This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse effects of early life toxic stress in preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk.
排除标准
- •receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV
结局指标
主要结局
Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for alertness and orientation ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Irritability Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for irritability ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Quality of Cry Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for quality of cry ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Percent Sleep Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for percent sleep ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Early Feeding Skill Assessment Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
EFS has 22 items (32-50 weeks PMA), summary scores, 5 subscales: respiratory regulation (range 5 - 15), oral-motor functioning (range 4 - 12), swallowing coordination (range 4 - 12), engagement (range 2 - 6), \& physiologic stability (range 4 - 12), where higher scores indicate better oral feeding skill development. The total score is the sum of the subscales and ranges from 19-57.
Feasibility of Intervention
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The count of participants who receive M-MILK in at least 50% of their scheduled M-MILK administrations. MILK will be considered feasible if M-MILK is implemented by nurses or parents after every hands-on care and during the beginning of a full gavage feeding at least 50% of the time.
Acceptability of Intervention
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale.
Feasibility of Intervention
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The count of participants who receive M-MILK in at least 50% of their scheduled M-MILK administrations. MILK will be considered feasible if M-MILK is implemented by nurses or parents after every hands-on care and during the beginning of a full gavage feeding at least 50% of the time.
Acceptability of Intervention
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale.
Retention
时间窗: 2 months corrected age
Retention will be described by the number of post-discharge follow-up surveys completed.
The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for scarf sign ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for motor development \& vigor ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for popliteal angle ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for alertness and orientation ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Irritability Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for irritability ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Quality of Cry Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for quality of cry ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Percent Sleep Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for percent sleep ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Early Feeding Skill Assessment Score
时间窗: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
EFS has 22 items (32-50 weeks PMA), summary scores, 5 subscales: respiratory regulation (range 5 - 15), oral-motor functioning (range 4 - 12), swallowing coordination (range 4 - 12), engagement (range 2 - 6), \& physiologic stability (range 4 - 12), where higher scores indicate better oral feeding skill development. The total score is the sum of the subscales and ranges from 19-57.
次要结局
- Parent Stressor Scale: NICU Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Parent Discharge Readiness Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Maternal Edinburgh Postnatal Depression Scale Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Parent Stressor Scale: NICU Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Parent Discharge Readiness Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Breastmilk Pumping Rate(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Breastfeeding Rate(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- Maternal Edinburgh Postnatal Depression Scale Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
研究者
Thao Griffith
Assistant Professor
Loyola University