Status:
COMPLETED
Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Prematurity
Eligibility:
All Genders
36-72 years
Brief Summary
Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity. This study is designed to evaluate the long-te...
Detailed Description
Over twelve percent of infants born less than 1,500 grams (VLBW) sustain brain injury with subsequent developmental delay. Although various neuroprotective strategies have been evaluated, none have be...
Eligibility Criteria
Inclusion
- Inclusion Criteria (preterm):
- birth weight 500-1,250 grams, gestational age ≤32 weeks
- hematocrit ≤55%
- ≤48 hours of age
- expected to survive greater than 72 hours
- consent signed by parent or guardian
- Inclusion Criteria (term):
- Former term born infants will be eligible if they have not experienced any episodes of hypoxia, hypoglycemia, hyperbilirubinemia, prenatal drug exposure, or sepsis.
- Exclusion Criteria (former preterms):
- hemorrhagic or hemolytic disease
- major congenital anomalies (such as trisomy 13, 18 or 21)
- major neurologic abnormality such as hydrocephalus or meningomyelocele
- complex congenital heart disease
- receiving Epo or are enrolled in an Epo study
- evidence of disseminated intravascular coagulation
- clinical seizures are present
- congenital thrombotic disease is suspected
- systolic blood pressures \>100 mm Hg (while not on pressor support) Infants with minor anomalies such as clinodactyly, single umbilical vessel or patent ductus are not excluded
- Exclusion criteria (term):
- hypoxia, hypoglycemia, hyperbilirubinemia, prenatal drug exposure, or sepsis
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01207778
Start Date
March 1 2010
End Date
December 31 2020
Last Update
August 4 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
MIND Research Network
Albuquerque, New Mexico, United States, 87131
2
UNM
Albuquerque, New Mexico, United States, 87131
3
University of Utah
Salt Lake City, Utah, United States, 84108