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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Sanliurfa, Turquía (Türkiye)
- Sanliurfa Neonatal Intensive Care Unit
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Reciprocal Scent Group
Participants received circadian-aligned feeding combined with reciprocal maternal-infant scent intervention for 21 days.
|
Maternal-infant reciprocal scent exposure combined with circadian-aligned feeding.
|
|
Experimental: Circadian Feeding Group
Participants received circadian-aligned breast milk feeding based on milk expression timing for 21 days.
|
Breast milk feeding synchronized with the timing of milk expression according to circadian rhythm.
|
|
Otro: Control Group
Participants received standard neonatal intensive care without additional sensory or circadian intervention.
|
Cuidado Estándar
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ime to Weaning From Mechanical Ventilation
Periodo de tiempo: 21 days
|
Duration from initiation of mechanical ventilation to successful extubation without reintubation for at least 48 hours.
|
21 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Daily Weight Gain
Periodo de tiempo: Baseline to Day 21
|
Change in neonatal body weight measured daily during the intervention period.
|
Baseline to Day 21
|
|
Breast Milk Volume
Periodo de tiempo: Weekly during 21 days
|
Daily expressed breast milk volume produced by mothers during the intervention period.
|
Weekly during 21 days
|
|
Hydration Status (Diaper Weight)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trabajo de parto prematuro, obstétrico
- Complicaciones obstétricas del parto
- Complicaciones del embarazo
- Nacimiento prematuro
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- 2025/8378
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .