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Completed

NCT Number: NCT03599167

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

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.

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Key information

Conditions

Practice Guideline of Erythrocyte Transfusion in Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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,…)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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

Acronym: RBCPREM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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