- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548050
Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine (ORLIKID)
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.
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Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Emilie Techer
- Phone Number: 02.62.90.62.83
- Email: emilie.techer@chu-reunion.fr
Study Contact Backup
- Name: Claire BRAYER
- Phone Number: 02.62.90.58.30
- Email: claire.brayer@chu-reunion.fr
Study Locations
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Saint-Denis, France, 97400
- Centre hospitalier universitaire de la Réunion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
mothers informed by untrained nurse
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mothers informed by trained nurse
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mothers informed by nurses trained 6 months ago
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
104/5000 Percentage of mothers who expressed colostrum before 24hours
Time Frame: 24hours after childbirth
|
24hours after childbirth
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020/CHU/26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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