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

9. juni 2026 opdateret af: Biyu Shen, Shanghai Jiao Tong University School of Medicine

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:

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Qiuyue Zhai, MS
  • Telefonnummer: +86 1832140548 +86 13681734307
  • E-mail: 2319957509@qq.com

Studiesteder

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Fujian Children's Hospital
        • Kontakt:
    • Jiangsu
      • Nantong, Jiangsu, Kina, 226001
        • Nantong First People's Hospital
        • Kontakt:
      • Nantong, Jiangsu, Kina, 226018
        • Nantong Maternal and Child Health Hospital
        • Kontakt:
      • Shanghai, Jiangsu, Kina, 215025
        • Children's Hospital of Soochow University
        • Kontakt:
      • Zhangjiagang, Jiangsu, Kina, 215600
        • Zhangjiagang First People's Hospital
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200127
        • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Biyu Shen, PhD
        • Underforsker:
          • Qiuyue Zhai, MS
        • Underforsker:
          • Fan fan, MS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Preterm infants born between 28 and 36 weeks of gestation Have reached full enteral feeding Written informed consent signed by a legal guardian

Exclusion Criteria:

Need 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 diseases or abnormalities that may affect normal feeding or sleep behavior, including:

Congenital anomalies, such as neurologic or chromosomal abnormalities Congenital gastrointestinal malformations or anorectal malformations Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis (NEC) Critical illnesses such as patent ductus arteriosus (PDA), neonatal sepsis, neutropenia, or coagulation disorders

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Routine Breast Milk Feeding
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.
Adfærdsmæssigt: 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.
Eksperimentel: Circadian-Synchronized 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Active Sleep to Quiet Sleep Ratio (AS:QS Ratio) at 37 Weeks of Corrected Gestational Age
Tidsramme: 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 2 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 a wearable EEG patch combined with a sleep mat. The EEG device uses a single-channel, three-electrode configuration and supports synchronized acquisition of EEG and pulse wave signals. All monitoring data will be preprocessed, scored, and exported using a standardized data processing workflow.
During a 12-hour monitoring period at 37 weeks of corrected gestational age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Each Sleep State During the Total Monitoring Period
Tidsramme: 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.
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
Tidsramme: 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.
During a 12-hour monitoring period at 37 weeks of corrected gestational age
Heart Rate Variability (HRV) Parameters During the Total Monitoring Period
Tidsramme: 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.
During a 12-hour monitoring period at 37 weeks of corrected gestational age

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gut Microbiota Composition in Stool Samples
Tidsramme: At enrollment and on the same day as the 12-hour sleep monitoring period at 37 weeks of corrected gestational age
Stool samples will be collected at enrollment and on the same day as sleep monitoring at 37 weeks of corrected gestational age to explore gut microbiota composition, diversity, and relative abundance of major bacterial taxa. Analyses will be exploratory.
At enrollment and on the same day as the 12-hour sleep monitoring period at 37 weeks of corrected gestational age

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SCMCIRB-K2026077-1

Plan for individuelle deltagerdata (IPD)

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