Clinical Trials Directory

Trials / Completed

CompletedNCT03599167

Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline

Evaluation of the Compliance to HAS 2014 (Haute Autorité de Santé) Guidelines for Red Blood Cells Transfusion in Preterm Infant in a French Neonatal Intensive Care Unit

Status
Completed
Phase
Study type
Observational
Enrollment
57 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
Healthy volunteers

Summary

The indications that motivated the decision to transfuse (or not) were analyzed to verify compliance with HAS recommendations. Medical records from 57 premature infants \< 32 weeks hospitalized between 2016 -2017 were retrospectively analysed, especially all the events related to monitoring of hemoglobin level and RBC transfusions during the first month of life. The criteria (postnatal age, rate of haemoglobin, type of breathing assistance, oxygen needing, medullary regeneration) on which rely the decision process in the HAS algorithm for the RBC transfusion were also considered, as well as the final decision actually adopted for each case (transfused/ not transfused). All this made it possible to determine the kappa coefficient for evaluation of agreement with HAS new guidelines in the investigator's medical staff.

Conditions

Timeline

Start date
2018-01-22
Primary completion
2018-01-22
Completion
2018-01-22
First posted
2018-07-26
Last updated
2018-07-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03599167. Inclusion in this directory is not an endorsement.