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OpenTrials
Completed

NCT Number: NCT03938675

Early Use of Raw Milk and Breastfeeding Continuation

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.

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Key information

Conditions

Breastfeeding Continuation

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in breastfeeding after hospital discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study

Acronym: DOAL

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 6, 2019
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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