Early Use of Raw Milk and Breastfeeding Continuation

NCT03938675 | Completed

• 1 other identifier: DOAL
• Study Type: observational
• Target: 516
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breastfeeding Continuation

Outcome Measures

Primary Outcomes (1)

• Change in breastfeeding 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.

  On Day 60 and Day 180 after hospital discharge

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Neonates with parents not fluent in French were excluded.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Officials

• Sophie Laborie, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: May 6, 2019
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 6, 2019

Record last verified: 2019-05