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NCT02819193 Clinical Trial

Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

Breastfeeding Clinical Trial

— DOAL  

Official title:
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02819193
Other study ID # 69HCL16_0379
Secondary ID
Status Completed
Phase N/A
First received June 28, 2016
Last updated June 29, 2016
Start date April 2012
Est. completion date December 2013

Study information
Verified date June 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.

Recruitment information / eligibility
Status Completed
Enrollment 665
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 42 Weeks
Eligibility Inclusion Criteria:

- Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized =7 days

Exclusion Criteria:

- Neonates with parents not fluent in French.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• raw mother's own milk
Infants receive mother's own milk before day 7.

Locations
Country Name City State
France Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, 32 Avenue Doyen Jean Lépine Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal breastfeeding Maternal breastfeeding is defined as the consumption of any MOM. It is classed as "exclusive" when all the fed milk will be MOM or "partial" when it will be completed by other milk or food. up to 6 months No
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