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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 1, 2027 → Sep 1, 2027
See other at-risk trials from Shanghai Jiao Tong University School of Medicine

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Sep 1, 2026 to Oct 8, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 3 to 2
    • Site details revised at 5 of 6 sites
    • Publications: details revised at 4 of 4 entries
  2. Start date: Jul 1, 2026 to Sep 1, 2026
    • Primary completion pushed from Jul 1, 2027 to Sep 1, 2027
    • Study completion pushed from Aug 1, 2027 to Sep 1, 2027
    v3
  3. Start date: Jun 1, 2026 to Jul 1, 2026
    • Primary completion pushed from Jun 1, 2027 to Jul 1, 2027
    • Eligibility criteria shortened, about 8 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07645677
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Preterm Infant, Sleep
Related terms Premature Birth
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov