MISTUAnalyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants: Observational Study.
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+3
+ Female Urogenital Diseases and Pregnancy Complications
+ Obstetric Labor Complications
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: August 1, 2015
Actual date on which the first participant was enrolled.This is an observational and prospective study involving approximately 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit from the Hospital Santa Casa de Misericordia after childbirth. Lactating mothers should have enough milk to provide enough maternal milk their infant(s) require plus additional collection of samples (3mL). After consenting to the study, milk from lactating mothers of preterm infants in the local ICU will be analyzed daily from the moment they express sufficient milk volume beyond their child's requirement until discharge (from 4th day of admission until 15th day of hospitalization ). Three mL of sample milk will be collected every morning and analyzed, according to hospital routine. Characteristics of subjects and details of their premature children, such as gestational age, birth weight (BMI) and birth details (causes of preterm birth, delivery, complications, etc) will be collected by applying a questionnaire on the first day of analysis. The nutritional composition of the last meal before the milk sample collection and also a three no consecutive nutrition questionnaire daily intake will be evaluated. The determination of the macronutrient content will be made from the use of Human Milk Analyzer MIRIS (MIRIS HMA), Uppsala, Switzerland, properly calibrated. The analyzer is based on the adopted infrared (IR) technology in combination with a patented technology. Sample collection, storage and analysis, as well as equipment conservation, will be carefully followed according to MIRIS protocol. Information about effectiveness, feasibility and equipment costs will also be evaluated. The data obtained by the HMA will be compared to the nutritional composition of human milk and nutritional needs of preterm found in the literature and included in the main guidelines
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives