Clinical Research Directory
Browse clinical research sites, groups, and studies.
Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
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.
Official title: Effect of Circadian-Synchronized Breast Milk Feeding on Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
0 Days - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-07-01
Completion Date
2027-08-01
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (6)
Fujian Children's Hospital
Fuzhou, Fujian, China
Nantong First People's Hospital
Nantong, Jiangsu, China
Nantong Maternal and Child Health Hospital
Nantong, Jiangsu, China
Children's Hospital of Soochow University
Shanghai, Jiangsu, China
Zhangjiagang First People's Hospital
Zhangjiagang, Jiangsu, China
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China