An interventional study of Circadian-Synchronized Breast Milk Feeding and Routine Breast Milk Feeding in Preterm Infant and Sleep, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 6 sites in China. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Supportive care
Among 79 studies in Premature Birth with a site in China — 26 open to participants now, 31 under way, 2 of them phase 3. Premature Birth · China.
Among the 79 studies in Premature Birth with a site in China, this one is the 28th largest by planned enrollment of the 44 interventional ones that give a count, is one of 10 that started in 2026, is one of 25 with no phase, reaches primary completion later than 20 of the 30 other live ones, and was the 77th registered.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
Browse Premature Birth studies →26 of the 79 studies in Premature Birth with a site in China are open now. Recruiting first, the newest first:
Guangzhou Women and Children's Medical Center · Sites in China
Ages up to 12 mo
Children's Hospital of Fudan University · Sites in China
Ages up to 1 days
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Sites in China
Ages 1 min–1 hrs
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
Ages 36 wk+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: 0 Days and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 7 · Phase 3 5 · Phase 4 8
First in 2006; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 84 across 1,669 interventional studies indexed under Premature Birth.
Median enrollment 195 across the 44 interventional studies, 541 across the 35 observational. Of the 31 that completed or were terminated, 1 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 79 have an industry lead sponsor. The 10 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Shanghai Jiao Tong University School of Medicine has 2 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
9 of the studies in Premature Birth with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03168516Phase 3University Hospital TuebingenEffects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants | 2026-12 |
| NCT06414655Peking University Third HospitalMulticenter Prospective Cohort Study of Twin Maternal-Child Dyads in China | 2026-11-30 |
| NCT07756177Sun Yat-sen UniversityGuangzhou Preterm and Term Birth Cohort Study | 2026-12-31 |
| NCT06234332Peking UniversityPeking University Birth Cohort in Weifang (PKUBC-WF) | 2026-12-31 |
| NCT04777760Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversitySurfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS) | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 79 studies in Premature Birth with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Routine 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.
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.
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.
Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age
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 the LANMAO Sleep X8 wearable EEG device 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.
Time frame: During a 12-hour monitoring period at 37 weeks of corrected gestational age
Proportion of Each Sleep State During the Total Monitoring Period
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.
Time frame: 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
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.
Time frame: During a 12-hour monitoring period at 37 weeks of corrected gestational age
Gut Microbiota Composition in Stool Samples
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.
Time frame: 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)
Plan to share: Undecided
Started Oct 2026 (actual). Primary completion is estimated for Sep 2027, 10 months after the start.
Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 10 months is below that.
Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 7, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shanghai Jiao Tong University School of Medicine →