Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA
研究概览
简要总结
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants?
Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in:
- Cortisol levels
- DNA methylation of the two stress related genes (NR3C1 and HSD11B2)
- Neurodevelopment
- Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.
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)
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at ≤ 32 weeks gestational age.
- •Receiving mother's own milk and/or donor human milk at the time of screening.
排除标准
- •Receiving only formula.
- •Gastrointestinal defects, i.e., cleft lip or cleft palate.
- •Congenital cardiac defects requiring surgery.
- •Necrotizing enterocolitis.
- •Chromosomal abnormalities.
研究组 & 干预措施
M-MILK Group
Infants in the M-MILK group will receive M-MILK intervention and standard of care. M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.
干预措施: Multisensory early oral administration of human milk (Other)
Control Group
Infants in the Control group will receive standard of care.
结局指标
主要结局
Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA
时间窗: 36 weeks postmenstrual age.
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks post-menstrual age (PMA). The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Oral feeding Skills: EFS assessment total score at PO Initiation
时间窗: Up to 12 weeks after birth.
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA
时间窗: 36 weeks postmenstrual age.
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks post-menstrual age (PMA). The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
次要结局
- Stress Regulation: Salivary Cortisol at 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Stress Regulation: Salivary Cortisol at PO Initiation(Up to 12 weeks after birth.)
- Stress Regulation: Salivary Cortisol at 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at PO Initiation(Up to 12 weeks after birth.)
- Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at PO Initiation(Up to 12 weeks after birth.)
- Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Attention score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Handling score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Self-Regulation 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Habituation score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Arousal score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Excitability score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Lethargy score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Hypertonicity score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Hypotonicity score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Nonoptimal Reflexes score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Asymmetric Reflexes score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Quality of Movement score 36 Weeks PMA(At 36 weeks postmenstrual age.)
- Neurodevelopment: NNNS-II Stress/Abstinence score 36 Weeks PMA(At 36 weeks postmenstrual age.)