Preterm InfantNCT07645677
Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial
A study testing Circadian-Synchronized Breast Milk Feeding and Routine Breast Milk Feeding in people with Preterm Infant and Sleep, run by Shanghai Jiao Tong University School of Medicine at 6 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Preterm Infant, Sleep
- What is being tested?
- Circadian-Synchronized Breast Milk Feeding and Routine Breast Milk Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesChina
- Study dates
- 8 Oct 2026to 1 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Fujian Children's Hospital
Fuzhou, Fujian, 350014
Qiongxia Ou, PhD, +86 13862937317, shenbiyu@126.com
Nantong First People's Hospital
Nantong, Jiangsu, 226001
Yuanyuan Zhu, +86 13862937317, shenbiyu@126.com
Nantong Maternal and Child Health Hospital
Nantong, Jiangsu, 226018
Jinfang Yan, +86 13862937317, shenbiyu@126.com
Children's Hospital of Soochow University
Shanghai, Jiangsu, 215025
Biyu Shen, PhD, +86 13862937317, shenbiyu@126.com
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Biyu Shen, PhD, +86 13862937317, shenbiyu@126.com
Biyu Shen, PhD
Zhangjiagang First People's Hospital
Zhangjiagang, Jiangsu, 215600
Minmin Sun, +86 13862937317, shenbiyu@126.com
About this study
Official title: 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:
Read more
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
- Being tested
- Circadian-Synchronized Breast Milk Feeding, Routine Breast Milk Feeding
- Keywords
- Breast Milk Feeding, Circadian Rhythm, Chrononutrition, NICU, Preterm Infant, Sleep
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian-Synchronized Breast Milk FeedingBehavioural
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 FeedingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Breast Milk Feeding | Active comparator | 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. Receives: Behavioral: Routine Breast Milk Feeding |
| Circadian-Synchronized Breast Milk Feeding | Experimental | 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. Receives: Behavioral: Circadian-Synchronized Breast Milk Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During a 12-hour monitoring period at 37 weeks of corrected gestational age
Secondary outcomes (2)
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.
Measured: 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.
Measured: During a 12-hour monitoring period at 37 weeks of corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start8 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyu Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645677
- Sponsor's protocol ID
- SCMCIRB-K2026077-1
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36474114Wang 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.
PubMed 36894247Italianer 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.
PubMed 32759654Temizsoy 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.
PubMed 40195944