Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity (MOCARE)
1 de julio de 2026 actualizado por: Ankara Yildirim Beyazıt University
PRETERM YENİDOĞANLARDA ANNE KOKUSUNUN APNE GELİŞİMİNE, FİZYOLOJİK PARAMETRELERE VE KİLO ALIMINA ETKİSİ
Apnea of prematurity is one of the most common complications in preterm infants hospitalized in neonatal intensive care units.
This randomized controlled trial was conducted to evaluate the effect of maternal odor exposure as a developmental care intervention on apnea frequency, physiological parameters, and growth outcomes in preterm infants.
Sixty preterm infants were randomly assigned to either a maternal odor intervention group or a routine care control group.
The intervention group received maternal odor using a cotton cloth carrying the mother's natural scent for five consecutive days.
The primary outcome was the daily number of apnea episodes.
Secondary outcomes included oxygen saturation, heart rate, respiratory rate, body temperature, weight, and head circumference.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Apnea of prematurity is a frequent complication of preterm birth and is associated with intermittent hypoxemia and adverse clinical outcomes. Developmental care interventions that provide familiar sensory stimulation may improve physiological stability in preterm infants. Maternal odor is a natural olfactory stimulus that may support autonomic regulation and respiratory stability through early sensory recognition.
This single-center, parallel-group, randomized controlled trial evaluated the effectiveness of maternal odor exposure in preterm infants admitted to the neonatal intensive care unit. Sixty eligible preterm infants were randomly assigned in a 1:1 ratio to either a maternal odor intervention group or a routine care control group. Maternal odor was provided using a cotton cloth impregnated with the mother's natural body odor, positioned approximately 10-15 cm from the infant's head for five consecutive days and replaced every 8 hours.
The primary outcome was the daily frequency of apnea episodes. Secondary outcomes included oxygen saturation (SpO₂), heart rate, respiratory rate, body temperature, weight, and head circumference. Outcomes were compared between groups to determine whether maternal odor exposure improves respiratory stability and physiological regulation in preterm infants.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Konya, Turquía (Türkiye), 06370
- Selcuk University Faculty of Medicine Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Preterm infants born between 26 and 37 weeks of gestation
- Birth weight between 1000 and 2500 g
- Hospitalized in the neonatal intensive care unit for at least 5 days
- Receiving oral or enteral feeding
- Written informed consent obtained from parent(s) or legal guardian(s)
Exclusion Criteria:
- Endotracheal intubation, mechanical ventilation, or nasal continuous positive airway pressure
- Receiving oxygen therapy
- Congenital heart disease
- Suspected or confirmed sepsis
- Intracranial hemorrhage
- Receiving analgesic, sedative, or muscle relaxant therapy
- Previous surgical procedure
- Development of a medical condition requiring withdrawal from the study or hospitalization for less than 5 days
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Maternal odor group
Preterm infants received maternal odor exposure using a cotton cloth carrying the mother's natural body odor placed 10-15 cm from the infant's head for five consecutive days in addition to routine neonatal intensive care.
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Maternal odor exposure was provided using a cotton cloth carrying the mother's natural body odor.
The cloth was placed approximately 10-15 cm from the infant's head during routine care for five consecutive days.
The cloth was replaced every 8 hours to maintain the maternal odor.
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Sin intervención: Control group
Preterm infants received routine neonatal intensive cate without maternal odor exposure
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Frequency of Apnea Episodes
Periodo de tiempo: Daily for 5 consecutive days
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Number of apnea episodes experienced by preterm infants during the 5-day study period.
Apnea episodes were recorded prospectively using the Premature Observation Form.
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Daily for 5 consecutive days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart Rate
Periodo de tiempo: Measured four times daily for 5 consecutive days
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Heart rate (beasts per minute) recorded during the study period and compared between the intervention and control groups
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Measured four times daily for 5 consecutive days
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Peripheral Oxygen Saturation
Periodo de tiempo: Measured four times daily for 5 consecutive days
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Peripheral Oxygen Saturation (%) measured repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Respiratory Rate
Periodo de tiempo: Measured four times daily for 5 consecutive days
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Respiratory rate (breaths per minute) recorded repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Body Temperature
Periodo de tiempo: Measured four times daily for 5 consecutive days
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Body temperature recorded repeatedly during the study period and compared between the maternal odor and control groups.
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Measured four times daily for 5 consecutive days
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Weight Gain
Periodo de tiempo: Baseline and Day 5
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Change in body weight (grams) from baseline to Day 5 and comparison between the maternal odor and control groups.
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Baseline and Day 5
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Head Circumference Growth
Periodo de tiempo: Baseline and Day 5
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Change in head cincumference (cm) from baseline to Day 5 and comparison between the maternal odor and control groups.
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Baseline and Day 5
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2022
Finalización primaria (Actual)
1 de junio de 2023
Finalización del estudio (Actual)
1 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2026
Publicado por primera vez (Actual)
8 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de julio de 2026
Última verificación
1 de junio de 2026
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
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Signos y Síntomas Respiratorios
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Nacimiento prematuro
- Apnea
Otros números de identificación del estudio
- EKIZILER-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be made publicly available.
The informed consent obtained from participants' parents/legal guardians did not include permission for sharing individual participant data with external researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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