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

NCT07645677 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Preterm Infant
  • Sleep

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2027-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645677 on ClinicalTrials.gov