Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sleep consolidation (longest nocturnal sleep bout)
研究概览
简要总结
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns.
However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant.
The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices.
A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups:
Intervention group: preterm infants receive expressed breast milk matched to the time of day it was expressed (day, evening or night)
Control group: preterm infants receive expressed breast milk without regard to timing (usual practice)
The main outcome is sleep consolidation at 6 months of age, measured objectively using actigraphy (a small wearable device that records sleep and activity). Additional outcomes include sleep patterns over time, circadian development, melatonin exposure, gut microbiota composition, and clinical outcomes such as infections and neurodevelopment.
The intervention does not involve any medication and uses the infant's usual nutrition. Risks are minimal and mainly relate to the additional effort required for milk labelling and timing.
This study will provide evidence on whether a simple, low-risk change in feeding practice can support infant sleep and early-life circadian development, with potential benefits for child health and family well-being.
详细描述
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns.
However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant.
The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices.
A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants born between 32+0 and 36+6 weeks' gestation
- •Age ≤ 1 month at enrolment
- •Infants routinely receiving expressed breast milk (fully or partially breastfed)
- •Written informed consent obtained from parent(s) or legal representative(s)
- •Ability of caregivers to comply with study procedures including milk labelling and feeding according to study allocation
排除标准
- •Prenatal exposure to illicit drugs (e.g. cannabis, cocaine, heroin, opiates) or significant alcohol exposure
- •Major congenital malformations or congenital infections
- •Significant underlying disease (excluding transient neonatal conditions such as feeding difficulties, hyperbilirubinaemia, hypoglycaemia, anaemia, respiratory distress syndrome, or apnoea-bradycardia syndrome)
研究组 & 干预措施
Chronobiologically Timed Feeding of Expressed Breast Milk
Infants receive expressed breast milk that is administered according to the time of expression (day, evening, or night), aligning feeding with circadian timing.
干预措施: Chronobiologically Timed Feeding of Expressed Breast Milk (Other)
Usual Feeding Practice (Untimed Expressed Breast Milk)
Infants receive expressed breast milk without regard to the time of expression (standard care).
干预措施: Usual Feeding Practice (Untimed Expressed Breast Milk) (Other)
结局指标
主要结局
Sleep consolidation (longest nocturnal sleep bout)
时间窗: At 6 months of age
Measured by actigraphy
次要结局
- Sleep fragmentation(At 2, 4, 6, 12, and 24 months)
- Circadian rhythm development (day-night activity ratios and circadian function index)(At 2, 4, 6, 12, and 24 months)
- Parent-reported sleep outcomes(At 2, 4, 6, 12, and 24 months)
- Melatonin circadian profiles(At 2, 4, 6, 12, and 24 months)
- Intestinal microbiota composition(At 2, 4, 6, 12, and 24 months)
- Infection rates(At 2, 4, 6, 12, and 24 months)
- Neurodevelopmental outcomes(24 months)