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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Early Use of Raw Milk and Breastfeeding Continuation

Clinicaltrials.gov identifier NCT03938675

Recruitment Status Completed

First Posted May 6, 2019

Last update posted May 6, 2019

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:Breastfeeding Continuation
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

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: April 2012
  • Actual Primary Completion Date: December 2013
  • Actual Study Completion Date: April 2014
Outcome Measures
  • Primary Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: up to 6 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: Neonates male or female admitted between April 2012 andJune 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.
Criteria

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
Contacts
Locations
Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Sophie Laborie, MD Hospices Civils de Lyon

More Information
  • Responsible Party: Hospices Civils de Lyon
  • ClinicalTrials.gov Identifier: NCT03938675 History of Changes
  • Other Study ID Numbers: DOAL
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 6, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No