Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin

NCT01207778 | Completed Results

• 2 other identifiers: 10-153R01HD059856
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 3

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-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.

Conditions

Prematurity

Keywords

brain; development; erythropoietin; neuroprotection; MRI

Outcome Measures

Primary Outcomes (1)

• Full Scale IQ, Performance IQ, Verbal IQ, Executive Function

  Infants who received ESAs during their initial hospitalization will perform significantly better on measures of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI) full scale IQ, performance IQ, verbal IQ, and executive function. Scores are standardized, 100 is an average score with a standard deviation of 15. Higher scores are better. Test scores range from 41 to 160.

  42-48 months and 66-72 months

Study Arms (3)

preterm ESA recipients

Former preterm infants 500-1250 grams who received erythropoietin (400 units/kg 3x/week) or darbepoetin (10 micrograms/kg 1x/week), from the first week of life through 35 weeks corrected gestation

preterm controls

Former preterm infants 500-1250 grams who received placebo (sham dosing), from first week of life through 35 weeks corrected gestation

term controls

Former term infants with normal delivery

Eligibility Criteria

• Age: 36 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants previously enrolled in NCT00334737, a randomized masked study of darbepoetin administration in preterm infants, are eligible for the study. In addition we will enroll term infants matched for age, gender and ethnicity to the preterm group to serve as healthy controls.

You may qualify if:

• 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
• Former term born infants will be eligible if they have not experienced any episodes of hypoxia, hypoglycemia, hyperbilirubinemia, prenatal drug exposure, or sepsis.

You may not qualify if:

• 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
• hypoxia, hypoglycemia, hyperbilirubinemia, prenatal drug exposure, or sepsis

Sponsors & Collaborators

• University of New Mexico: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

MIND Research Network

Albuquerque, New Mexico, 87131, United States

Location

UNM

Albuquerque, New Mexico, 87131, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• Lowe JR, Rieger RE, Moss NC, Yeo RA, Winter S, Patel S, Phillips J, Campbell R, Baker S, Gonzales S, Ohls RK. Impact of Erythropoiesis-Stimulating Agents on Behavioral Measures in Children Born Preterm. J Pediatr. 2017 May;184:75-80.e1. doi: 10.1016/j.jpeds.2017.01.020. Epub 2017 Feb 6.

  PMID: 28185625 DERIVED

• Ohls RK, Cannon DC, Phillips J, Caprihan A, Patel S, Winter S, Steffen M, Yeo RA, Campbell R, Wiedmeier S, Baker S, Gonzales S, Lowe J. Preschool Assessment of Preterm Infants Treated With Darbepoetin and Erythropoietin. Pediatrics. 2016 Mar;137(3):e20153859. doi: 10.1542/peds.2015-3859. Epub 2016 Feb 15.

  PMID: 26908704 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Robin Ohls
• Organization: University of Utah

robin.ohls@hsc.utah.edu

505-400-7644

Study Officials

• Robin K Ohls, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: March 1, 2010
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2020
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2022-05

Locations

US (3)