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DOAL: Early Use of Raw Milk and Breastfeeding Continuation

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03938675
Collaborator
(none)
516
Enrollment
24
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    516 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study
    Actual Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in breastfeeding after hospital discharge [On Day 60 and Day 180 after hospital discharge]

      Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed. Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge. It was classed as "exclusive" when all the fed milk was MOM, or "partial" when it was completed by other milk and/or food.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    • Principal Investigator: Sophie Laborie, MD, Hospices Civils de Lyon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT03938675
    Other Study ID Numbers:
    • DOAL
    First Posted:
    May 6, 2019
    Last Update Posted:
    May 6, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 6, 2019