Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants

NCT02971904 | Completed DMC

• 1 other identifier: DanoneELN-02
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low-Birth-Weight Infant; Premature Infants

Keywords

newborn; prematurity; preterm; human milk; human milk analyzer; neonatology; neonatal intensive care unit; low birth weight

Outcome Measures

Primary Outcomes (1)

• evolution of the nutritional composition of maternal milk of mothers of premature infants

  Maternal milk energy and protein daily analysis by MIRIS (Mid infrared Human Milk Analyzer)

  up to six months

Secondary Outcomes (1)

• Impact of mother´s diet in the milk composition

  up to six months

Study Arms (1)

Human milk collection

Lactating mothers should have enough milk to provide enough maternal milk their preterm 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. Personal details of mothers and their infants 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 nutrition questionnaire intake will be evaluated.

Other: human milk collection

Interventions

human milk collection OTHER

Human milk collection

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Danone Early Life Nutrition Brazil: lead
• Irmandade da Santa Casa de Misericordia de Sao Paulo: collaborator

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07