Human milk lyophilisate - Phase 1 and 2 study: safety, tolerability and effectiveness
- Conditions
- Preterm newbornHuman MilkHuman Milk BancNewrbornM01.060.703.520M01.060.703.520.520A12.200.467N02.278.065.600
- Registration Number
- RBR-8nnpfm
- Lead Sponsor
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method