CClinicalTrials.gg
CompletedNCT03599167RBCPREMUpdated Jul 26, 2018

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

An observational study in Practice Guideline of Erythrocyte Transfusion in Preterm Infant, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
57
Sex
All
01

Study 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.

02

Conditions studied

  • Practice Guideline of Erythrocyte Transfusion in Preterm Infant

Browse trials for

Keywords

  • red blood cell transfusion
  • preterm infant
  • HAS guideline
  • transfusion guidelines
  • kappa agreement test application
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 57 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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

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,...)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
57 participants (actual)
Patient registry
No
06

What researchers measure

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)

    from the birth until the day 28, with respect to postnatal age and the gestational age

    Time frame: during the first month of life

  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

    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

    Time frame: during the first month of life

07

Study locations

1 site
  • Centre Hospitalier Universitaire d'Amiens
    Amiens, Picardie 80000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03599167
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jul 26, 2018
Start date
Jan 22, 2018
Primary completion
Jan 22, 2018
Completion
Jan 22, 2018
Last update
Jul 26, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion