Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial
3 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Biyu Shen, PhD
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
Copia de seguridad de contactos de estudio
- Nombre: Qiuyue Zhai, MS
- Número de teléfono: +86 1832140548 +86 13681734307
- Correo electrónico: 2319957509@qq.com
Ubicaciones de estudio
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Fujian
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Fuzhou, Fujian, Porcelana, 350014
- Fujian Children's Hospital
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Contacto:
- Qiongxia Ou, PhD
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
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Jiangsu
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Nantong, Jiangsu, Porcelana, 226001
- Nantong First People's Hospital
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Contacto:
- Yuanyuan Zhu
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
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Nantong, Jiangsu, Porcelana, 226018
- Nantong Maternal and Child Health Hospital
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Contacto:
- Jinfang Yan
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
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Shanghai, Jiangsu, Porcelana, 215025
- Children's Hospital of Soochow University
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Contacto:
- Biyu Shen, PhD
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
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Zhangjiagang, Jiangsu, Porcelana, 215600
- Zhangjiagang First People's Hospital
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Contacto:
- Minmin Sun
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200127
- Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
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Contacto:
- Biyu Shen, PhD
- Número de teléfono: +86 13862937317
- Correo electrónico: shenbiyu@126.com
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Investigador principal:
- Biyu Shen, PhD
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Sub-Investigador:
- Qiuyue Zhai, MS
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Sub-Investigador:
- Fan fan, MS
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Each Sleep State During the Total Monitoring Period
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gut Microbiota Composition in Stool Samples
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SCMCIRB-K2026077-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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