N/A
N=77
Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT01207778 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function — 79; 91; 103; 83 standardized score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full Scale IQ, Performance IQ, Verbal IQ, Executive Function |
79; 91; 103; 83; 92; 101 | — |
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-term developmental effects of one promising neuroprotective treatment,erythropoietin (Epo), when given in the neonatal period. Using detailed neurodevelopmental testing and state-of-the-art brain imaging, we hope to determine whether this is an effective treatment to prevent brain injury associated with prematurity, and to lay the groundwork for further studies to improve the developmental outcome of infants delivered prematurely.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01207778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.