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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548050
Other study ID # 2020/CHU/26
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 14, 2020
Est. completion date April 21, 2022

Study information

Verified date September 2023
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Colostrum is an irreplaceable nutrient rich in protein and antibodies. Its taste and smell are similar to those of amniotic fluid (therefore rich for the senses of the baby separated from his mother). It should be offered to every newborn baby, regardless of term and the type of breastfeeding their mom wants. The early expression of colostrum, within the first 2 hours after childbirth, is an essential way to start lactation of a mother separated from her baby. The sooner and more often the mother stimulates her breasts, the more milk she will have for her baby in the weeks to come. Manual expression of milk is therefore an essential gesture to initiate lactation, maintain it, and giving colostrum to babies as early as possible is beneficial. Two studies carried out in the neonatal medicine department of Felix Guyon Hospital in premature infants <33 week of amenorrhea (PRE'OLACT study in 2015-2016 by Dr RAJAOFERA and Diploma from university (DU) breastfeeding brief in 2018-2019 by Dr GRONDARD) found the same results: the desire for breastfeeding is 80% but manual expression of colostrum before H24 is only achieved by 30% of mothers and before H6 in only 6% of cases. .


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date April 21, 2022
Est. primary completion date April 21, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - All mothers, over 18 years of age, of newborns hospitalized in neonatal medicine at the University Hospital Center (CHU) - Félix GUYON Hospital during the study period. - Expressed no opposition from mothers to their participation and to the use of their data Exclusion Criteria: - Outborn - Mother not hospitalized in the maternity ward of Félix Guyon Hospital - Prognosis for the child engaged in the first 24 hours - Difficult oral comprehension - Medical contraindication to breastfeeding - Unseen mother <3D

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nurses training
Presentation of the benefits of colostrum and manual expression technique on a slide show and practical workshops for learning the manual expression technique on a fictitious breast. Presentation to all staff of a service protocol for early colostrum donation.

Locations

Country Name City State
France Centre Hospitalier Universitaire de la Réunion Saint-Denis

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 104/5000 Percentage of mothers who expressed colostrum before 24hours 24hours after childbirth