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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Biyu Shen, PhD
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
研究連絡先のバックアップ
- 名前：Qiuyue Zhai, MS
- 電話番号：+86 1832140548 +86 13681734307
- メール：2319957509@qq.com
研究場所
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Fujian
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Fuzhou、Fujian、中国、350014
- Fujian Children's Hospital
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コンタクト：
- Qiongxia Ou, PhD
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
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Jiangsu
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Nantong、Jiangsu、中国、226001
- Nantong First People's Hospital
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コンタクト：
- Yuanyuan Zhu
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
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Nantong、Jiangsu、中国、226018
- Nantong Maternal and Child Health Hospital
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コンタクト：
- Jinfang Yan
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
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Shanghai、Jiangsu、中国、215025
- Children's Hospital of Soochow University
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コンタクト：
- Biyu Shen, PhD
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
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Zhangjiagang、Jiangsu、中国、215600
- Zhangjiagang First People's Hospital
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コンタクト：
- Minmin Sun
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200127
- Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
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コンタクト：
- Biyu Shen, PhD
- 電話番号：+86 13862937317
- メール：shenbiyu@126.com
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主任研究者：
- Biyu Shen, PhD
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副調査官：
- Qiuyue Zhai, MS
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副調査官：
- Fan fan, MS
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age
時間枠：During a 12-hour monitoring period at 37 weeks of corrected gestational age
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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.
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During a 12-hour monitoring period at 37 weeks of corrected gestational age
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Each Sleep State During the Total Monitoring Period
時間枠：During a 12-hour monitoring period at 37 weeks of corrected gestational age
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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.
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During a 12-hour monitoring period at 37 weeks of corrected gestational age
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Number of Complete AS-QS-Arousal Sleep Cycles During the Total Monitoring Period
時間枠：During a 12-hour monitoring period at 37 weeks of corrected gestational age
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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.
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During a 12-hour monitoring period at 37 weeks of corrected gestational age
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Heart Rate Variability (HRV) Parameters During the Total Monitoring Period
時間枠：During a 12-hour monitoring period at 37 weeks of corrected gestational age
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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.
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During a 12-hour monitoring period at 37 weeks of corrected gestational age
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gut Microbiota Composition in Stool Samples
時間枠：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)
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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.
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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)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Italianer MF, Naninck EFG, Roelants JA, van der Horst GTJ, Reiss IKM, Goudoever JBV, Joosten KFM, Chaves I, Vermeulen MJ. Circadian Variation in Human Milk Composition, a Systematic Review. Nutrients. 2020 Aug 4;12(8):2328. doi: 10.3390/nu12082328.
- Ryan MAJ, Mathieson SR, Livingstone V, O'Sullivan MP, Dempsey EM, Boylan GB. Sleep state organisation of moderate to late preterm infants in the neonatal unit. Pediatr Res. 2023 Feb;93(3):595-603. doi: 10.1038/s41390-022-02319-x. Epub 2022 Dec 6.
- Wang W, Huang L, Zhang X, Lin L, Chen X, Zhong C, Chen R, Wu M, Yang S, Tu M, Cao X, Tan T, Zhu W, Liu J, Zhang H, Yang S, Li N, Yang X, Hao L, Yang R, Yang N. Association of Breastfeeding Practices During the First 3 Months with Infant Sleep Trajectories: A Prospective Cohort Study. J Nutr. 2023 Feb;153(2):562-568. doi: 10.1016/j.tjnut.2022.12.018. Epub 2022 Dec 26.
- Temizsoy E, Uysal G, Karadag N. The Effect of a Chronobiological Feeding Model on Growth Parameters and Length of Hospitalization in Preterm Infants: A Randomized Controlled Study. Breastfeed Med. 2025 Jun;20(6):432-440. doi: 10.1089/bfm.2024.0221. Epub 2025 Apr 8.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月8日
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。