Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine (ORLIKID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548050
Recruitment Status : Not yet recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief 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.

.


Condition or disease Intervention/treatment
Early Breastfeeding Other: Nurses training

Layout table for study information
Study Type : Observational
Estimated Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Group/Cohort Intervention/treatment
mothers informed by untrained nurse
mothers informed by trained nurse 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.

mothers informed by nurses trained 6 months ago 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.




Primary Outcome Measures :
  1. 104/5000 Percentage of mothers who expressed colostrum before 24hours [ Time Frame: 24hours after childbirth ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All mothers, over 18 years of age, of newborns hospitalized in neonatal medicine at the CHU - Félix GUYON .
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548050


Contacts
Layout table for location contacts
Contact: Emilie Techer 02.62.90.62.83 emilie.techer@chu-reunion.fr
Contact: Claire BRAYER 02.62.90.58.30 claire.brayer@chu-reunion.fr

Locations
Layout table for location information
France
Centre Hospitalier Universitaire de la Réunion
Saint-Denis, France, 97400
Contact: Emilie TECHER    0262906289 ext +33    emilie.techer@chu-reunion.fr   
Principal Investigator: Claire BRAYER         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04548050    
Other Study ID Numbers: 2020/CHU/26
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No