- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02221167
Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes (Rx Milk)
Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population.
We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Iowa
-
Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Children's Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Gestational age greater than or equal to 37 weeks
- Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
- Chronologic age of 24-48 hours old at the time of study enrollment
Exclusion Criteria:
- twins and higher level multiples
- infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
- mother incarcerated
- mother's age <18 years
- mother reports mature milk production prior to study enrollment
- mother does not speak English
- infants offered > 1 supplemental feeding of formula or donor milk
- weight loss greater than 10%
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
|
|
|
Comparador activo: Donor Milk
Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk "comes in." (until the onset of lactogenesis II)
|
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Any formula use at 1 week of age
Periodo de tiempo: 1 week
|
Any formula intake within the last 24 hours.
|
1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Exclusive breastfeeding
Periodo de tiempo: 3 months
|
Infants receiving breast milk and no formula in the last 24 hours.
|
3 months
|
|
Any breastfeeding at 3 months
Periodo de tiempo: 3 months
|
Infants receiving some breast milk in addition to some formula in the last 24 hours.
|
3 months
|
|
Any breastfeeding
Periodo de tiempo: 1 month
|
1 month
|
|
|
Exclusive breastfeeding
Periodo de tiempo: 1 month
|
1 month
|
|
|
Exclusive breastfeeding
Periodo de tiempo: 2 months
|
2 months
|
|
|
Any breastfeeding
Periodo de tiempo: 2 months
|
2 months
|
|
|
Any breastfeeding
Periodo de tiempo: 1 week
|
1 week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laura R Kair, MD, University of Iowa
- Director de estudio: Tarah T Colaizy, MD, MPH, University of Iowa
- Director de estudio: Valerie J Flaherman, MD, MPH, University of California, San Francisco
Publicaciones y enlaces útiles
Publicaciones Generales
- Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13.
- Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.
- Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047.
- Kair LR, Flaherman VJ, Colaizy TT. Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial. Clin Pediatr (Phila). 2019 May;58(5):534-540. doi: 10.1177/0009922819826105. Epub 2019 Jan 28.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- 201406730
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. .