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Circadian Feeding and Reciprocal Scent Intervention in NICU

2. juni 2026 opdateret af: Esra SABANCI BARANSEL, Inonu University

Babies Nourished by the Rhythm of Time: Maternal and Fetal Effects of Circadian Feeding and Reciprocal Scent Intervention in Neonatal Intensive Care

Objective: This study evaluated the effects of circadian-aligned feeding and reciprocal scent intervention on premature infants receiving mechanical ventilation and on postpartum depression levels in their mothers.

Methods: In this randomized controlled trial, 75 premature infants and their mothers were assigned to reciprocal scent, circadian feeding, or control groups (n=25 each). Interventions were applied for 21 days. Outcomes included time to weaning from mechanical ventilation, weight gain, hydration status, breast milk production, and maternal Edinburgh Postnatal Depression Scale (EPDS) scores.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This randomized controlled trial is designed to evaluate the effects of circadian-aligned feeding and reciprocal scent intervention, both alone and in combination, on clinical outcomes in premature infants receiving mechanical ventilation support and on postpartum depression levels in their mothers.

A total of 75 premature infants and their mothers will be enrolled and randomly assigned to one of three groups: a reciprocal scent intervention group, a circadian-aligned feeding group, or a control group (25 infant-mother dyads per group).

The interventions will be implemented for 21 days during the infants' hospitalization period. The primary outcome measure is time to weaning from mechanical ventilation. Secondary outcome measures include daily weight gain, hydration status assessed through diaper weight, daily breast milk production, and maternal postpartum depression assessed using the Edinburgh Postnatal Depression Scale (EPDS).

The study aims to determine whether these non-pharmacological interventions are associated with improvements in neonatal clinical outcomes and maternal psychological well-being.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

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

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Ingen

Beskrivelse

Inclusion Criteria: Preterm neonates born before 37 weeks of gestation

  • Intubated neonates requiring mechanical ventilation support
  • Within the first 24 hours after birth
  • Receiving enteral feeding
  • Mothers willing to participate in the study

Exclusion Criteria:

  • Congenital anomalies or major malformations
  • Genetic syndromes or severe systemic diseases
  • Contraindications to breastfeeding (e.g., maternal HIV infection or cytotoxic drug use)
  • Inability of mothers to participate in study procedures

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Reciprocal Scent Group
Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days.
Adfærdsmæssigt: Reciprocal Scent Intervention
Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
Eksperimentel: Circadian Feeding Group
Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days.
Adfærdsmæssigt: Circadian-Aligned Feeding
Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
Andet: Control Group
Participants received standard neonatal intensive care without additional sensory or circadian intervention.
Andet: Standardbehandling (i kontrolarm)
Standardbehandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ime to Weaning From Mechanical Ventilation
Tidsramme: 21 days
Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.
21 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily Weight Gain
Tidsramme: Baseline to Day 21
Change in neonatal body weight measured daily during the intervention period.
Baseline to Day 21
Breast Milk Volume
Tidsramme: Weekly during 21 days
Daily expressed breast milk volume produced by mothers during the intervention period.
Weekly during 21 days
Hydration Status (Diaper Weight)
Tidsramme: Baseline to Day 21
Neonatal hydration status assessed by diaper weight measurements during routine diaper changes.
Baseline to Day 21
Edinburgh Postnatal Depression Scale (EPDS) Score
Tidsramme: Baseline and Day 21
Maternal postpartum depression symptoms assessed using the Edinburgh Postnatal Depression Scale. Edinburgh Postnatal Depression Scale (EPDS) is a validated screening tool for postpartum depressive symptoms. The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms and a worse outcome.
Baseline and Day 21

Samarbejdspartnere og efterforskere

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

Sponsor

Inonu University

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 (Faktiske)

1. oktober 2025

Primær færdiggørelse (Faktiske)

1. november 2025

Studieafslutning (Faktiske)

1. april 2026

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025/8378

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly available in order to protect participant confidentiality and privacy

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