Clinical trial NCT02971904: Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
Official title: Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants: Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low-Birth-Weight Infant
Premature Infants
Keywords: newborn
prematurity
preterm
human milk
human milk analyzer
neonatology
neonatal intensive care unit
low birth weight
Lead sponsor: Danone Early Life Nutrition Brazil
Sponsor class: INDUSTRY
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
First posted: 2016-11-23
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, stable mothers, mothers of premature infants who were hospitalized at the neonatal ICU of the Santa Casa de Misericórdia after the birth. Mothers should have enough milk to breastfeed their children, and samples will be collected from April to July 2016.

Brief summary: An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until 15th day of hospitalization or until discharge.

Considering the lack of evidence related to breast milk nutritional composition from Brazilian lactating mothers of preterm infants; and also the utilization of human milk analyzer as a tool to optimize nutritional therapy and reach proper growth and development of preterm babies, this study aim to evaluate the nutritional composition of human milk from lactating mothers of preterm infant during the hospitalization, the infant grow and also the applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Healthy mothers with hospitalized preterm newborns
* Enough milk to breastfeed their child and donate 3 ml / day for the study
* Being the first sample of milk collected from the 4th day of hospitalization.

Exclusion Criteria:

* Mothers who are not breastfeeding
* Do not have enough milk for collection.

Primary outcomes:
measure: evolution of the nutritional composition of maternal milk of mothers of premature infants
timeFrame: up to six months
Secondary outcomes:
measure: Impact of mother´s diet in the milk composition
timeFrame: up to six months
Other outcomes:
Locations:
Study officials:
References: