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NCT00182390 · ClinicalTrials.gov registry record · Phase 3
Premature Infants in Need of Transfusion (PINT)
A Phase 3 study, sponsored by McMaster University.
- Completed
- Registry status
- Phase 3
- Development phase
- 424
- Enrollment target
NCT00182390 is a Phase 3 study that has completed, run by McMaster University. The registered enrollment target is 424 participants.
The verdict
NCT00182390, a Phase 3 study, has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 424 participants
- Enrollment target
Study Summary
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly). Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold. Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.
Interventions
- PROCEDURE Red blood cell transfusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2001-02 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00182390
The ClinicalTrials.gov registry entry for NCT00182390 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Red blood cell transfusion is the first listed.
NCT00182390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00182390 about?
NCT00182390 is a clinical study titled "Premature Infants in Need of Transfusion (PINT)". Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculo...
What is the current status of trial NCT00182390?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2001-02. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00182390?
The interventions under investigation include: Red blood cell transfusion (PROCEDURE).
Who is sponsoring clinical trial NCT00182390?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
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