Low-Birth-Weight InfantMISTUNCT02971904
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational study of Low-Birth-Weight Infant and Premature Infants, run by Danone Early Life Nutrition Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low-Birth-Weight Infant, Premature Infants
- What is being tested?
- human milk collection
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2017
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Mothers who are not breastfeeding
- Do not have enough milk for collection.
About this study
Official title: Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants: Observational Study.
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.
Read the 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
- Conditions
- Low-Birth-Weight Infant, Premature Infants
- Being tested
- human milk collection
- Keywords
- newborn, prematurity, preterm, human milk, human milk analyzer, neonatology, neonatal intensive care unit, low birth weight
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human milk collectionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: human milk collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to six months
Secondary outcomes (1)
Impact of mother´s diet in the milk composition
Maternal diet questionnaire in admission and daily last meal record before every human milk collection
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Birth-Weight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Danone Early Life Nutrition Brazil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971904
- Sponsor's protocol ID
- DanoneELN-02
- Acronym
- MISTU
- Status last verified
- Jul 2017
- First submitted
- 21 Nov 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants: Observational Study.
- ClinicalTrials.gov ID
- NCT02971904
- Acronym / sponsor ID
- MISTU / DanoneELN-02
- Conditions
- Low-Birth-Weight Infant, Premature Infants
- Keywords
- newborn, prematurity, preterm, human milk, human milk analyzer, neonatology, neonatal intensive care unit, low birth weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danone Early Life Nutrition BrazilIndustry (pharma, biotech, devices)
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human milk collection | – | Other: human milk collectionLactating 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Mothers who are not breastfeeding
- Do not have enough milk for collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human milk collection | Other | Human milk collection |
Primary outcome
evolution of the nutritional composition of maternal milk of mothers of premature infants
Time frame: up to six months
Maternal milk energy and protein daily analysis by MIRIS (Mid infrared Human Milk Analyzer)
1 secondary outcome
Impact of mother´s diet in the milk composition
Time frame: up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-Birth-Weight Infant and Premature Infants, run by Danone Early Life Nutrition Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of the nutritional composition of maternal milk of mothers of premature infants (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.