Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial
2026년 6월 9일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Biyu Shen, PhD
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
연구 연락처 백업
- 이름: Qiuyue Zhai, MS
- 전화번호: +86 1832140548 +86 13681734307
- 이메일: 2319957509@qq.com
연구 장소
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Fujian
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Fuzhou, Fujian, 중국, 350014
- Fujian Children's Hospital
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연락하다:
- Qiongxia Ou, PhD
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
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Jiangsu
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Nantong, Jiangsu, 중국, 226001
- Nantong First People's Hospital
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연락하다:
- Yuanyuan Zhu
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
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Nantong, Jiangsu, 중국, 226018
- Nantong Maternal and Child Health Hospital
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연락하다:
- Jinfang Yan
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
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Shanghai, Jiangsu, 중국, 215025
- Children's Hospital of Soochow University
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연락하다:
- Biyu Shen, PhD
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
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Zhangjiagang, Jiangsu, 중국, 215600
- Zhangjiagang First People's Hospital
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연락하다:
- Minmin Sun
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200127
- Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
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연락하다:
- Biyu Shen, PhD
- 전화번호: +86 13862937317
- 이메일: shenbiyu@126.com
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수석 연구원:
- Biyu Shen, PhD
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부수사관:
- Qiuyue Zhai, MS
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부수사관:
- Fan fan, MS
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
Preterm infants born between 28 and 36 weeks of gestation Have reached full enteral feeding Written informed consent signed by a legal guardian
Exclusion Criteria:
Need 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 diseases or abnormalities that may affect normal feeding or sleep behavior, including:
Congenital anomalies, such as neurologic or chromosomal abnormalities Congenital gastrointestinal malformations or anorectal malformations Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis (NEC) Critical illnesses such as patent ductus arteriosus (PDA), neonatal sepsis, neutropenia, or coagulation disorders
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age
기간: 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 2 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 a wearable EEG patch combined with a sleep mat.
The EEG device uses a single-channel, three-electrode configuration and supports 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Each Sleep State During the Total Monitoring Period
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gut Microbiota Composition in Stool Samples
기간: At enrollment and on the same day as the 12-hour sleep monitoring period at 37 weeks of corrected gestational age
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Stool samples will be collected at enrollment and on the same day as sleep monitoring at 37 weeks of corrected gestational age to explore gut microbiota composition, diversity, and relative abundance of major bacterial taxa.
Analyses will be exploratory.
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At enrollment and on the same day as the 12-hour sleep monitoring period at 37 weeks of corrected gestational age
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 8월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
잠에 대한 임상 시험
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Fujian Shengdi Pharmaceutical Co., Ltd.모병Bstructive sleep apnea (OSA) 및 비만중국