- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Growth during first three weeks of intervention
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
Prazo: 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
Prazo: 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
Prazo: 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]
Prazo: 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
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016TFO2
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