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

3. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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 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.
During a 12-hour monitoring period at 37 weeks of corrected gestational age

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Gut Microbiota Composition in Stool Samples
Tidsramme: 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)
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.
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SCMCIRB-K2026077-1

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