Premature Infants in Need of Transfusion (PINT)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight

Conditions
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Anemia of Prematurity

Intervention / Treatment
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* Procedure: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birth weight <1000g postnatal age <48 hours no transfusion beyond first 6 hours of life estimated gestational age of 30 completed weeks or less Exclusion Criteria: infant considered non-viable by attending physician infant has cyanotic congenital heart disease infant's parents known to be opposed to blood transfusion either parent has hemoglobinopathies or congenital anemias infant has hemolytic disease infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion prior treatment with or intention to treat with erythropoietin

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Red blood cell transfusion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) |  | neonatal phase | 
| Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) |  | follow-up phase 18 months corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth in weight and head circumference |  | neonatal phase | 
| time to extubation |  | neonatal phase | 
| time on oxygen |  | neonatal phase | 
| length of hospital stay until discharge home |  | neonatal phase | 
| confirmed necrotizing enterocolitis |  | neonatal phase | 
| apnea requiring treatment |  | neonatal phase | 
| culture-proven infections |  | neonatal phase | 
| use of post-natal steroids |  | neonatal phase | 
| mean levels of hemoglobin |  | neonatal phase | 
| number of transfusions |  | neonatal phase | 
| number of donor exposures |  | neonatal phase | 
| serum ferritin levels |  | neonatal phase | 
| milder forms of cerebral palsy |  | follow-up phase 18 months corrected age | 
| milder neurologic disorder |  | follow-up phase 18 months corrected age | 
| personal and social functional capabilities |  | follow-up phase 18 months corrected age | 
| hydrocephalus requiring a shunt |  | follow-up phase 18 months corrected age | 
| seizure disorder |  | follow-up phase 18 months corrected age | 
| respiratory disease |  | follow-up phase 18 months corrected age | 
| iron nutritional status |  | follow-up phase 18 months corrected age | 
| physical growth including head size |  | follow-up phase 18 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ELBW premature infants, neonatal transfusion, bronchopulmonary dysplasia, periventricular leukomalacia, ventriculomegaly, retinopathy of prematurity