- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02865941
Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured? (TFO2)
Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.
The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Christoph Fusch, MD, PhD
- Número de teléfono: 75721 +1 521 2100
- Correo electrónico: fusch@mcmaster.ca
Copia de seguridad de contactos de estudio
- Nombre: Niels Rochow, MD
- Número de teléfono: 23106 +1 521 2100
- Correo electrónico: rochow@mcmaster.ca
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8S 4K1
- Faculty of Health Science, McMaster Children's Hospital
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Contacto:
- Christoph Fusch, MD, PhD, FRCPC
- Número de teléfono: 75721 +1 905 521 2100
- Correo electrónico: fusch@mcmaster.ca
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Investigador principal:
- Christoph Fusch, MD, PhD, FRCPC
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Sub-Investigador:
- Niels Rochow, MD
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Sub-Investigador:
- Gerhard Fusch, PhD
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Sub-Investigador:
- Salhab el Helou, MD, FRCPC
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Sub-Investigador:
- Sabiha Ahmad
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Sub-Investigador:
- Akshdeep Singh Bhatia
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Sub-Investigador:
- Klaus Wutzke, PhD
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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:
- Gestational age < 30 weeks (maternal dates or early fetal ultrasound);
- Tolerating an enteral intake of ≥100 mL/kg/d for ≥ 24h;
- Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥150 mL/kg/d) has been achieved;
- Written informed consent has been obtained from the infant's legal representative.
- Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
- Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.
Exclusion Criteria:
- Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
- Babies with enterostoma or short gut syndrome;
- Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
- Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;
- Sepsis - all infants with gram-negative sepsis will be removed from the study;
- Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
- Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen >10 mmol/L and creatinine of 130mmol/L
- Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;
- Probability of transfer to another neonatal intensive care unit or level II nursery outside the McMaster Children's Hospital, as discussed with the most responsible physician (MRP)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 5 milk analysis
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Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
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Experimental: 1 milk analysis
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Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Growth during first three weeks of intervention
Periodo de tiempo: first three weeks during intervention before 36 weeks of gestation
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first three weeks during intervention before 36 weeks of gestation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
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from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
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Weight Gain
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
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from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
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Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until discharge
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Measured by mass spectroscopy
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from inclusion at postmenstrual age <30 weeks until discharge
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Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]
Periodo de tiempo: first three weeks during intervention before 36 weeks of gestation
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first three weeks during intervention before 36 weeks of gestation
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Feeding intolerance questionaire
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until discharge
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volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention
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from inclusion at postmenstrual age <30 weeks until discharge
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Fat mass [g]
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until discharge
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Measured with bioelectrical impedance analysis
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from inclusion at postmenstrual age <30 weeks until discharge
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Lean mass [g]
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until discharge
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Measured with bioelectrical impedance analysis
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from inclusion at postmenstrual age <30 weeks until discharge
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Head circumference [cm]
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until discharge
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Measured by tape
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from inclusion at postmenstrual age <30 weeks until discharge
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Body length [cm]
Periodo de tiempo: from inclusion at postmenstrual age <30 weeks until discharge
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Measured by length board
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from inclusion at postmenstrual age <30 weeks until discharge
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christoph Fusch, MD, PhD, McMaster Children's Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Fusch G, Rochow N, Choi A, Fusch S, Poeschl S, Ubah AO, Lee SY, Raja P, Fusch C. Rapid measurement of macronutrients in breast milk: How reliable are infrared milk analyzers? Clin Nutr. 2015 Jun;34(3):465-76. doi: 10.1016/j.clnu.2014.05.005. Epub 2014 May 17.
- Rochow N, Fusch G, Choi A, Chessell L, Elliott L, McDonald K, Kuiper E, Purcha M, Turner S, Chan E, Xia MY, Fusch C. Target fortification of breast milk with fat, protein, and carbohydrates for preterm infants. J Pediatr. 2013 Oct;163(4):1001-7. doi: 10.1016/j.jpeds.2013.04.052. Epub 2013 Jun 12.
- Choi A, Fusch G, Rochow N, Sheikh N, Fusch C. Establishment of micromethods for macronutrient contents analysis in breast milk. Matern Child Nutr. 2015 Oct;11(4):761-72. doi: 10.1111/mcn.12053. Epub 2013 Jun 18.
- Fusch G, Choi A, Rochow N, Fusch C. Quantification of lactose content in human and cow's milk using UPLC-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Dec 1;879(31):3759-62. doi: 10.1016/j.jchromb.2011.09.053. Epub 2011 Oct 6.
- Fusch G, Mitra S, Rochow N, Fusch C. Target fortification of breast milk: levels of fat, protein or lactose are not related. Acta Paediatr. 2015 Jan;104(1):38-42. doi: 10.1111/apa.12804. Epub 2014 Oct 2.
- Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
- Rochow N, Fusch G, Zapanta B, Ali A, Barui S, Fusch C. Target fortification of breast milk: how often should milk analysis be done? Nutrients. 2015 Apr 1;7(4):2297-310. doi: 10.3390/nu7042297.
- Fusch G, Kwan C, Huang RC, Rochow N, Fusch C. Need of quality control programme when using near-infrared human milk analyzers. Acta Paediatr. 2016 Mar;105(3):324-5. doi: 10.1111/apa.13305. Epub 2016 Jan 19. No abstract available.
- Choi A, Fusch G, Rochow N, Fusch C. Target Fortification of Breast Milk: Predicting the Final Osmolality of the Feeds. PLoS One. 2016 Feb 10;11(2):e0148941. doi: 10.1371/journal.pone.0148941. eCollection 2016.
- Kotrri G, Fusch G, Kwan C, Choi D, Choi A, Al Kafi N, Rochow N, Fusch C. Validation of Correction Algorithms for Near-IR Analysis of Human Milk in an Independent Sample Set-Effect of Pasteurization. Nutrients. 2016 Feb 26;8(3):119. doi: 10.3390/nu8030119.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- 2016TFO2
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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