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Clinical Characterization of Very and Extremely Preterm Infants Who Received Excess Erythrocyte Transfusions With Respect to HAS 2014 Recommendations

NCT06909487 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2026-02-11

No results posted yet for this study

Summary

Prematurity affects around 60,000 births a year in France. Extremely premature babies are particularly fragile and require multiple erythrocyte transfusions to maintain an effective hemoglobin level for metabolism and continued somatic and neurological development. Many known risk factors, such as multiple blood sampling for biological diagnosis, lead to a more rapid fall in hemoglobin concentration, reducing the amount of oxygen delivered in the tissues. In addition, red blood cell regeneration is very low in premature infants, while the half-life of red blood cells is shorter than in older children and adults. The result is severe anemia. Its main treatment is erythrocyte transfusion. It is associated with biological benefits, but has digestive, ophthalmological, pulmonary, metabolic and neurological side effects. To ensure a good benefit/risk ratio, a commission of the HAS issued recommendations in 2014 for erythrocyte transfusion in premature infants \< 32 weeks of amenorrhea in France. Yet many transfusions continue to be performed outside the HAS 2014 criteria. A retrospective monocentric study was carried out in order to understand this situation. Data from premature infants \< 31 weeks of amenorrhea (wks) born between July 2022 and July 2024 were collected via computerized hospitalization records (DxCare, Diane and Demserv software). Their transfusion status during the first twenty-eight days of life was analyzed. The HAS decision algorithm was used to identify excess transfusions and develop a patient classification.

Conditions

  • Very Preterm and Extremely Preterm Birth
  • Anemia
  • Erythrocyte Transfusion
  • Excess Transfusion

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909487 on ClinicalTrials.gov