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

Practice Guideline of Erythrocyte Transfusion in Preterm Infant Clinical Trial

— RBCPREM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599167
• Other study ID #: PI01-MME-BESSARION
• Status: Completed
• Start date: January 22, 2018
• Est. completion date: January 22, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• preterm infant hospitalized in Amiens School hospital (CHU Amiens-Picardie) between October 2016 and April 2017 during the first month of life, with allowed access on data recorded in medical files concerning the evolution of clinical characteristics (body weight,…) and the results of laboratory analyses performed during this initial hospital stay.

Exclusion Criteria:

• less than 25 weeks or more than 32 weeks at birth

• any hemoglobin dosage during the hospital stay

• serious congenital malformation

• known or documented neonatal red blood cell disease (inherited hemolysis, enzymopathy of red blood cell membrane,…)

Related Conditions & MeSH terms

• Practice Guideline of Erythrocyte Transfusion in Preterm Infant
• Premature Birth

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks).		during the first month of life
Secondary	Evolution of the haemoglobin level (Hematocrit)	from the birth until the day 28, with respect to postnatal age and the gestational age	during the first month of life
Secondary	volume of blood loss		during the first month of life
Secondary	number of transfusion during the first month of life		during the first month of life
Secondary	correlation between the number of transfusion and the volume of blood loss		during the first month of life
Secondary	Analyses of neonatal morbidity associated with blood transfusion in premature neonates under 32 weeks of pregnancy	Neonatal morbidity are patent ductus arterious, intraventricular hemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of the prematurity, materno-fetal infection and the late-onset infection, and diverse hematological practices	during the first month of life