LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-25

Study Completion Date

2025-09-30

Brief Summary

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The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.

The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.

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Detailed Description

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Conditions

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Prematurity of Fetus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Physiopathology

Samples of breastmilk and infant serum and questionnaires.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Maternal decision of breastfeeding
* Born between 28 and 34 weeks of amenorrhea
* No important congenital pathology except prematurity
* Efficiency of the breastfeeding compatible with the research by the investigator
* Information and authorization of the parents or the parental authority

Exclusion Criteria

* Maternal decision of not breastfeeding
* Born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea
* Important congenital pathology
* Efficiency of the breastfeeding incompatible with the research by the investigator
* Opposition from parents or the parental authority to participate to the research study

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No