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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age [Срок оценки: During a 12-hour monitoring period at 37 weeks of corrected gestational age]

Вторичные конечные точки (3)

• Proportion of Each Sleep State During the Total Monitoring Period [Срок оценки: 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 [Срок оценки: During a 12-hour monitoring period at 37 weeks of corrected gestational age]
• Heart Rate Variability (HRV) Parameters During the Total Monitoring Period [Срок оценки: During a 12-hour monitoring period at 37 weeks of corrected gestational age]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 6 центров

• Fujian Children's Hospital — Фучжоу
• Nantong First People's Hospital — Nantong
• Nantong Maternal and Child Health Hospital — Nantong
• Children's Hospital of Soochow University — Шанхай
• Zhangjiagang First People's Hospital — Zhangjiagang
• Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of M — Шанхай

Публикации

• 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. PMID 36474114
• 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. PMID 36894247
• 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. PMID 32759654
• 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. PMID 40195944

Идентификаторы

NCT: NCT07645677 · SCMCIRB-K2026077-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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