RBR-8nnpfm招募中1 期
utrition of very low birth weight preterm newborns using a concentrate with human milk lyophilisate - phase 1 and 2 study: safety, tolerability and effectiveness - LioNeo: LIOphilisate of human milk for NEOnates with very low birth weight
Conselho Nacional de Desenvolvimento Científico e Tecnológico0 个研究点开始时间: 2019年6月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 0D 至 14D（—）
入选标准
- •It will be included in this study, very low birth weight newborns (VLBWN) who were admitted to the Intensive Care Units and Neonatal Intermediate Care of the Children’s Hospital of Ribeirão Preto Medical School - University of São Paulo (HC-FMRP-USP). Parent or legal guardian needs to sign the informed consent to participate in the research. Inclusion criteria for LBWN are: male and female sexes; who had birth weight >= 750 grams and <= 1500 grams in Phase 1 and less than or equal to 1500 grams in Phase 2; from any ethnicity; prematurely born (less than 37 weeks of gestational age); considered small (SGA) or adequate for gestational age (AGA); receiving human milk, whether raw maternal (which will be kept) and / or human milk from the bank in the volume of 100 ml / kg / day; whose mother, father or legal guardian authorizes participation in this study and, thus, signed the Free and Informed Consent Form; in a situation of twinning, one of the newborns will be drawn for each group; stable hemodynamically, without use of vasoactive drugs.
排除标准
- •The exclusion criteria (Phase 1 and Phase 2) will be: newborns considered large for gestational age; that presence of major malformations; periventricular and intraventricular hemorrhage (HPIV) degrees III and IV; children of minor mothers without accompanying.
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