Early Use of Raw Milk and Breastfeeding Continuation

NCT ID: NCT03938675

Last Updated: 2019-05-06

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

COMPLETED

Total Enrollment

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-01

Study Completion Date

2014-04-01

Brief Summary

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BACKGROUND:

Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.

OBJECTIVES:

This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.

METHODS:

This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.

Detailed Description

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Conditions

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Breastfeeding Continuation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Raw maternal own milk before day 7

Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.

No interventions assigned to this group

No Raw maternal own milk before day 7

Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.

Exclusion Criteria

* Neonates with parents not fluent in French were excluded.
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Laborie, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Other Identifiers

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DOAL

Identifier Type: -

Identifier Source: org_study_id

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