Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182390
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2005-09-13
Brief Title:
Premature Infants in Need of Transfusion PINT
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns 1000g Birth Weight
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 leukomalaciaventriculomegaly
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR MCT-58455 | None | None | None |
| CIHR MCT-41549 | None | None | None |