Vitamin D Supplementation for Extremely Preterm Infants
8 de febrero de 2017 actualizado por: Namasivayam Ambalavanan, University of Alabama at Birmingham
Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial
The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.
Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.
Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.
Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.
All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
Fase
- Fase 2
- Fase 3
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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Alabama
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Birmingham, Alabama, Estados Unidos, 35249
- University of Alabama at Birmingham
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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
1 minuto a 1 semana (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks
Exclusion Criteria:
- Major congenital/chromosomal anomalies
- Moribund infant with low likelihood of survival, in opinion of the clinical team
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
|
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours.
Other 3 doses will be placebo (sterile water).
Duration of 28 postnatal days
Otros nombres:
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
Otros nombres:
|
|
Comparador de placebos: Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
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Sterile water 0.5ml given orally every 6 hours.
Duration of 28 postnatal days
|
|
Comparador activo: Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
|
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours.
Other 3 doses will be placebo (sterile water).
Duration of 28 postnatal days
Otros nombres:
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total number of days alive and off respiratory support in the first 28 days
Periodo de tiempo: 28 days
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The total number of days alive and off respiratory support.
Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).
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28 days
|
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Serum vitamin D concentration
Periodo de tiempo: Day after birth 28
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Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)
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Day after birth 28
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of sepsis episodes treated with antibiotics for at least 5 days
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
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Number of episodes of culture proven or clinically suspected sepsis episodes treated with antibiotics for at least 5 days
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
|
Sepsis
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Culture proven or culture negative clinically treated course consistent with sepsis
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)
Periodo de tiempo: 36 weeks gestational age corrected
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A physiologic oxygen challenge test will be administered to infants from 36.0 weeks gestation to 37.0 weeks gestation to determine a need for supplemental oxygen to keep saturation levels between 88-95%.
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36 weeks gestational age corrected
|
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Duration of mechanical ventilation after randomization
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
|
Days alive and off mechanical ventilation in the first 28 days after birth
Periodo de tiempo: 28 days
|
Counted as days alive without mechanical ventilation for any part of a day
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28 days
|
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Number of re-intubation events
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Counted as number of reintubations for purposes of respiratory support
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Death
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Cardiorespiratory failure
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Surgical necrotizing enterocolitis or intestinal perforation
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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25(OH)D concentrations >60ng/ml (150 nmol/L)
Periodo de tiempo: 14 postnatal (+/- 2 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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14 postnatal (+/- 2 days)
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25(OH)D concentrations >60ng/ml (150 nmol/L)
Periodo de tiempo: 28 days postnatal age (+/- 3 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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28 days postnatal age (+/- 3 days)
|
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Serum calcium level
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Serum calcium measurement per blood obtained either centrally or by heel stick, performed for clinical care.
High serum calcium level is greater than 3 mmol/l of total calcium or total calcium of >12 mg/dL, or ionized calcium >2 mml/L.
|
Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
|
Urine calcium level
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Calcium measurement per urine, random sampling.
High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Meningitis
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Culture proven or culture negative clinically treated course consistent with meningitis
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Death or Neurodevelopmental Impairment
Periodo de tiempo: Birth to 22-26 months of age
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Birth to 22-26 months of age
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Ariel A. Salas, MD, University of Alabama at Birmingham
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
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
1 de junio de 2012
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2012
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2012
Publicado por primera vez (Estimar)
17 de mayo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
8 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Trastornos Nutricionales
- Avitaminosis
- Enfermedades por deficiencia
- Desnutrición
- Complicaciones del embarazo
- Complicaciones obstétricas del parto
- Trabajo de parto prematuro, obstétrico
- Lesión pulmonar
- Infantil, Prematuro, Enfermedades
- Lesión pulmonar inducida por ventilador
- Deficiencia de vitamina D
- Nacimiento prematuro
- Displasia broncopulmonar
- Efectos fisiológicos de las drogas
- Micronutrientes
- Agentes de conservación de la densidad ósea
- Hormonas y agentes reguladores del calcio
- Vitamina D
- Colecalciferol
- Vitaminas
- Ergocalciferoles
Otros números de identificación del estudio
- UAB Neo 006
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. .