Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01702805
Eligibility Criteria:
Inclusion Criteria:
* Birth weight less than or equal to 1000 grams.
* Gestational age at least 22 weeks but less than 29 weeks
* Admitted to the NICU within 48 hours of life
Exclusion Criteria:
* Considered nonviable by the attending neonatologist
* Cyanotic congenital heart disease
* Parents opposed to the transfusion of blood
* Parents with hemoglobinopathy or congenital anemia
* In-utero fetal transfusion
* Twin-to-twin transfusion syndrome
* Isoimmune hemolytic disease
* Lack of parental consent
* Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.
* Prior blood transfusion on clinical grounds beyond the first 6 hours of life
* Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course
* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.
* High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
48 Hours
Study:
NCT01702805
Study Brief:
Protocol Section:
NCT01702805