- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00838188
Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm infants, although there is no evidence that this is actually the case. It is also not known whether the method of feeding affects energy expenditure. We hypothesized that resting energy expenditure (REE) would be higher after breastfeeding than after bottle feeding.
PATIENTS AND METHODS. preterm ( >32 weeks GA) stable infants who are nourished entirely by their mothers' breast milk will be studied when fed expressed breast milk either by bottle or at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is evaluated by pre- and post feeding weighing.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Tel Aviv, Israel
- Department of Neonatology, Tel Aviv Sourasky Medical Center
-
Tel-Aviv, Israel
- Sourasky Medical Center
-
-
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:
- Thermally stable infants were nursed in an open and unwarmed bassinet.
- All fed solely by their mothers' breast milk equivalent to at least 150 cc/kg/day divided into eight meals and growing steadily
Exclusion Criteria:
- Infants with congenital anomalies and infants who had either more than five daily episodes of apnea of prematurity or any apnea requiring assistance or methylxanthine therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
1
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast.
Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
2
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast.
Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Breast - feeding first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast.
Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Bottle first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast.
Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
Way of feeding
Each infant is evaluated twice, once after breastfeeding and once after bottle feeding of breast milk using a Premature Nipple & Ring (Ross Products Division, Columbus OH, USA).
In this way, each infant serves as its own control.
REE is recorded for 20 minutes after each meal
|
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast.
Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
The primary goal of this study was to compare resting energy expenditure (REE) in preterm infants who were fed their mothers' expressed milk by bottle and at the breast
Periodo de tiempo: 20 minutes after each meal
|
20 minutes after each meal
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured
Periodo de tiempo: Not relevant
|
Not relevant
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Irit Berger, MD
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- 920060356
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. .