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Study Comparing Platelet Transfusion Volumes in Premature Babies

NCT06095648 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2023-10-23

No results posted yet for this study

Summary

Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby.

Participants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls/kg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls/kg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.

Conditions

Interventions

OTHER

Dose of platelet transfusion

Intervention is using a lower (5ml/kg) compared to usual (15ml/kg) dose of platelets for transfusion in non-bleeding babies born at or before 32 weeks in NICU

Sponsors & Collaborators

  • Health Research Board, Ireland

    collaborator OTHER

  • National Maternity Hospital, Ireland

    collaborator OTHER

  • Irish Blood Transfusion Service

    collaborator OTHER

  • University College Dublin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-28
Primary Completion
2026-08-31
Completion
2028-08-31

Countries

  • Ireland

Study Locations

More Related Trials

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 NCT06095648 on ClinicalTrials.gov