- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03938675
Early Use of Raw Milk and Breastfeeding Continuation (DOAL)
Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study
BACKGROUND:
Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.
OBJECTIVES:
This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.
METHODS:
This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Exclusion Criteria:
- Neonates with parents not fluent in French were excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Raw maternal own milk before day 7
Without any intervention, investigators observed whether neonates received raw MOM during the first week of life.
Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.
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No Raw maternal own milk before day 7
Without any intervention, investigators observed whether neonates received raw MOM during the first week of life.
Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in breastfeeding after hospital discharge
Periodo de tiempo: On Day 60 and Day 180 after hospital discharge
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Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed.
Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge.
It was classed as "exclusive" when all the fed milk was MOM, or "partial" when it was completed by other milk and/or food.
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On Day 60 and Day 180 after hospital discharge
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sophie Laborie, MD, Hospices Civils de Lyon
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
Otros números de identificación del estudio
- DOAL
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.
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