Preterm Infant, Sleep
Conditions
Keywords
Breast Milk Feeding, Circadian Rhythm, Chrononutrition, NICU, Preterm Infant, Sleep
Brief 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.
Interventions
BEHAVIORALCircadian-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.
BEHAVIORALRoutine 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
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age | During a 12-hour monitoring period 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 PSG 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Each Sleep State During the Total Monitoring Period | During a 12-hour monitoring period at 37 weeks of corrected gestational age | 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. |
| Number of Complete AS-QS-Arousal Sleep Cycles During the Total Monitoring Period | During a 12-hour monitoring period at 37 weeks of corrected gestational age | 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. |
| Heart Rate Variability (HRV) Parameters During the Total Monitoring Period | During a 12-hour monitoring period at 37 weeks of corrected gestational age | Heart rate variability (HRV) parameters measured during the entire monitoring period. HRV reflects variation in beat-to-beat intervals and will be used to describe autonomic nervous system activity across sleep states during monitoring. |
Countries
China
Contacts
CONTACTBiyu Shen, PhD
CONTACTQiuyue Zhai, MS
Outcome results
None listed