Circadian Feeding and Reciprocal Scent Intervention in NICU
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.
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Sanliurfa, Tyrkia (Türkiye)
- Sanliurfa Neonatal Intensive Care Unit
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Reciprocal Scent Group
Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days.
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Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
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Eksperimentell: Circadian Feeding Group
Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days.
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Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
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Annen: Control Group
Participants received standard neonatal intensive care without additional sensory or circadian intervention.
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Standardbehandling
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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ime to Weaning From Mechanical Ventilation
Tidsramme: 21 days
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Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.
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21 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Daily Weight Gain
Tidsramme: Baseline to Day 21
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Change in neonatal body weight measured daily during the intervention period.
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Baseline to Day 21
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Breast Milk Volume
Tidsramme: Weekly during 21 days
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Daily expressed breast milk volume produced by mothers during the intervention period.
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Weekly during 21 days
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Hydration Status (Diaper Weight)
Tidsramme: Baseline to Day 21
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Neonatal hydration status assessed by diaper weight measurements during routine diaper changes.
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Baseline to Day 21
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Edinburgh Postnatal Depression Scale (EPDS) Score
Tidsramme: Baseline and Day 21
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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.
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Baseline and Day 21
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Obstetrisk arbeid, prematur
- Obstetriske arbeidskomplikasjoner
- Graviditetskomplikasjoner
- For tidlig fødsel
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
Andre studie-ID-numre
- 2025/8378
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