Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03599167
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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.

Condition or disease
Practice Guideline of Erythrocyte Transfusion in Preterm Infant

Layout table for study information
Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : January 22, 2018
Actual Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks). [ Time Frame: during the first month of life ]

Secondary Outcome Measures :
  1. Evolution of the haemoglobin level (Hematocrit) [ Time Frame: during the first month of life ]
    from the birth until the day 28, with respect to postnatal age and the gestational age

  2. volume of blood loss [ Time Frame: during the first month of life ]
  3. number of transfusion during the first month of life [ Time Frame: during the first month of life ]
  4. correlation between the number of transfusion and the volume of blood loss [ Time Frame: during the first month of life ]
  5. Analyses of neonatal morbidity associated with blood transfusion in premature neonates under 32 weeks of pregnancy [ Time Frame: during the first month of life ]
    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



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
preterm infant hospitalized in Amiens School hospital (CHU Amiens-Picardie) between October 2016 and April 2017 during the first month of life
Criteria

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,…)

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): NCT03599167


Locations
Layout table for location information
France
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, France, 80000
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03599167     History of Changes
Other Study ID Numbers: PI01-MME-BESSARION
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

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

Keywords provided by Centre Hospitalier Universitaire, Amiens:
red blood cell transfusion
preterm infant
HAS guideline
transfusion guidelines
kappa agreement test application

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications