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Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial

2026年9月3日 更新者：Biyu Shen、Shanghai Jiao Tong University School of Medicine

Effect of Circadian-Synchronized Breast Milk Feeding on Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial

This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU).

The study mainly aims to answer the following questions:

Can this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding?

Researchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants.

Participants will:

Be randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding.

Receive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age.

Have changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Biyu Shen, PhD
  • 电话号码：+86 13862937317
  • 邮箱：shenbiyu@126.com

研究联系人备份

  • 姓名：Qiuyue Zhai, MS
  • 电话号码：+86 1832140548 +86 13681734307
  • 邮箱：2319957509@qq.com

学习地点

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国、350014
        • Fujian Children's Hospital
        • 接触：
    • Jiangsu
      • Nantong、Jiangsu、中国、226001
        • Nantong First People's Hospital
        • 接触：
      • Nantong、Jiangsu、中国、226018
        • Nantong Maternal and Child Health Hospital
        • 接触：
      • Shanghai、Jiangsu、中国、215025
        • Children's Hospital of Soochow University
        • 接触：
      • Zhangjiagang、Jiangsu、中国、215600
        • Zhangjiagang First People's Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200127
        • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
        • 接触：
        • 首席研究员：
          • Biyu Shen, PhD
        • 副研究员：
          • Qiuyue Zhai, MS
        • 副研究员：
          • Fan fan, MS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Preterm infants born between 28 weeks and 36 weeks plus 6 days of gestation.
  • Infants who have reached full enteral feeding.
  • Written informed consent signed by a legal guardian.

Exclusion Criteria:

  • Need for invasive respiratory support, such as endotracheal intubation.
  • Use of sedatives or other medications that may affect the central nervous system or sleep rhythm.
  • Presence of congenital neurologic or chromosomal abnormalities.
  • Presence of congenital gastrointestinal malformations or anorectal malformations.
  • Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis.
  • Critical illnesses such as patent ductus arteriosus, neonatal sepsis, neutropenia, or coagulation disorders.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Routine Breast Milk Feeding
Preterm infants in this group will receive routine breast milk feeding according to standard NICU practice. Expressed breast milk will be prepared and administered without matching the time of milk expression to the time of feeding.
行为的：Routine Breast Milk Feeding
In this intervention, preterm infants will receive routine breast milk feeding according to standard NICU practice. Expressed breast milk will be prepared and administered without matching the time of milk expression to the time of feeding.
实验性的：Circadian-Synchronized Breast Milk Feeding
Preterm infants in this group will receive circadian-synchronized breast milk feeding in the NICU. Expressed breast milk will be classified and labeled according to the time of milk expression into 4 time periods: morning (06:00-12:00), afternoon (12:00-18:00), evening (18:00-24:00), and late night/early morning (00:00-06:00). During the study, breast milk collected within each predefined time period will be used preferentially for feedings scheduled within the corresponding time period. This feeding approach is intended to keep the timing information in breast milk as consistent as possible with the infant's feeding time and will continue for at least 2 weeks during the study.
行为的：Circadian-Synchronized Breast Milk Feeding
In this intervention, expressed breast milk will be classified and labeled according to the time of milk expression into 4 predefined periods: morning (06:00-12:00), afternoon (12:00-18:00), evening (18:00-24:00), and late night/early morning (00:00-06:00). During the study, breast milk collected within each predefined time period will be used preferentially for feedings scheduled within the corresponding time period. This intervention is designed to keep the timing information in breast milk as consistent as possible with the infant's feeding time and will be implemented for at least 2 weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age
大体时间：During a 12-hour monitoring period at 37 weeks of corrected gestational age
The primary outcome is the ratio of active sleep (AS) to quiet sleep (QS) across the entire monitoring period at 37 weeks of corrected gestational age. Active sleep is one of the two main neonatal sleep states and is considered the precursor of rapid eye movement (REM) sleep. Sleep data will be collected during a 12-hour monitoring period using PSG in combination with the 5S Contactless Sleep Tracking Mat. The patch-based device uses a single-channel, three-electrode configuration and supports the synchronized acquisition of EEG and pulse wave signals. All monitoring data will be preprocessed, scored, and exported using a standardized data-processing workflow.
During a 12-hour monitoring period at 37 weeks of corrected gestational age

次要结果测量

结果测量
措施说明
大体时间
Proportion of Each Sleep State During the Total Monitoring Period
大体时间：During a 12-hour monitoring period at 37 weeks of corrected gestational age
The proportion of time spent in each sleep state during the entire monitoring period, including active sleep (AS), quiet sleep (QS), intermediate sleep (IS), arousal, and wake. Each sleep state will be expressed as a percentage of the total monitoring time.
During a 12-hour monitoring period at 37 weeks of corrected gestational age
Number of Complete AS-QS-Arousal Sleep Cycles During the Total Monitoring Period
大体时间：During a 12-hour monitoring period at 37 weeks of corrected gestational age
The number of complete sleep cycles observed during the entire monitoring period, defined as transitions from active sleep (AS) to quiet sleep (QS) and then to arousal. This measure is used to describe sleep organization during the monitoring period.
During a 12-hour monitoring period at 37 weeks of corrected gestational age
Heart Rate Variability (HRV) Parameters During the Total Monitoring Period
大体时间：During a 12-hour monitoring period at 37 weeks of corrected gestational age
Heart rate variability (HRV) parameters measured during the entire monitoring period. HRV reflects variation in beat-to-beat intervals and will be used to describe autonomic nervous system activity across sleep states during monitoring.
During a 12-hour monitoring period at 37 weeks of corrected gestational age

其他结果措施

结果测量
措施说明
大体时间
Gut Microbiota Composition in Stool Samples
大体时间：At enrollment (T0, within 48 hours prior to randomization) and on the same day as the 12 hour sleep monitoring period at 37 weeks of corrected gestational age (T1)
Stool samples will be collected at enrollment (T0, within 48 hours prior to randomization) and on the same day as the 12 hour sleep monitoring period at 37 weeks of corrected gestational age (T1). Specimens will be collected using fecal collection tubes with preservation solution, stored at room temperature, and delivered for testing on the day of or the day after collection. Gut microbiota composition will be assessed by 16S rRNA gene amplicon sequencing, including α diversity (Shannon index, species richness), β diversity (Bray Curtis, UniFrac), and relative abundance (%) of major bacterial phyla and genera.This is an exploratory analysis to examine associations between gut microbiota parameters and infant sleep outcomes, and to compare differences between the intervention and control groups.
At enrollment (T0, within 48 hours prior to randomization) and on the same day as the 12 hour sleep monitoring period at 37 weeks of corrected gestational age (T1)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Jiao Tong University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SCMCIRB-K2026077-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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