The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known.
We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be the same before as after a packed red blood cell (PRBC) transfusion among anemic premature infants.
Sixty anemic infants (25-32 weeks GA, feeding >= 60 cc/kg/day) will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion. Infants will be stratified by current weight into two groups (< 1250 grams and > 1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion. Randomization will be by block design, with block sizes ranging from two to six infants. The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant.
The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants. Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants. Statistical analysis will include paired and unpaired Student t-tests and regression analysis.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Magee-Womens Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment
- First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled.
- Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day
- A planned packed red blood cell transfusion, as per the clinical team, for anemia
- Infant is very likely to require a blood transfusion according to the attending neonatologist.
Exclusion Criteria:
- Known congenital anomalies of the heart, brain, kidneys or intestine
- Chromosomal abnormality
- Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
- Twin to twin transfusion sequence
- Higher order multiples
- Patent ductus arteriosus known to be present or currently being treated
- History of definite necrotizing enterocolitis Bell Stage 2 or greater
- Concurrent treatments with antibiotics or steroids
- Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential feeds
- Concurrent enrollment in another randomized trial
- Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: group 1
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion
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Comparador activo: group 2
Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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babies receiving the intervention are fed during the PRBC transfusion
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Sin intervención: group 3
All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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Experimental: group 4
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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babies receiving the intervention are fed during the PRBC transfusion
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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 Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Periodo de tiempo: 1 hour
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Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion
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1 hour
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gretchen Krimmel, MD, University of Pittsburgh
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0404184
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre Anemia de la prematuridad
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Queens College, The City University of New YorkReclutamientoPublicación de artículos enviados al American Journal of Public HealthEstados Unidos
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Children's Healthcare of AtlantaTerminadoNiños que se sometieron a un trasplante de corazón antes de los 18 años | Atención recibida en Children's Healthcare of AtlantaEstados Unidos