Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants



Status:Recruiting
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:September 20, 2017
End Date:September 2023
Contact:Robin Ohls, MD
Email:robin.ohls@hsc.utah.edu
Phone:801-581-7052

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Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will
have improved neurocognitive outcome at 22-26 months compared to placebo

Advances in neonatal care have led to significant improvements in the survival of the nearly
60,000 very low birth weight (VLBW) infants born each year in the U.S. Improving
neurodevelopmental outcomes for these preterm infants continues to be a major goal for
neonatal care providers. A subset of these infants sustain a grade 3 or 4 intraventricular
hemorrhage (IVH) resulting in an increase in the incidence of developmental delay. Moreover,
almost one third of preterm infants with normal head ultrasounds also develop cognitive
delay. Although a variety of neuroprotective treatment strategies have been evaluated, no
specific treatment has been identified to reduce or prevent brain injury in these most
vulnerable preterm infants.

A potential neuroprotective therapy involves administering erythropoiesis stimulating agents
(ESAs) such as erythropoietin (Epo) and Darbepoetin (Darbe, a longer acting ESA). In addition
to stimulating erythropoiesis, ESAs have been shown to be protective in the developing brain
in animal models, making it possibly beneficial for very premature infants who are at risk
for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. The
neuroprotective mechanisms of ESAs include increased neurogenesis, decreased neuronal
susceptibility to glutamate toxicity, decreased neuronal apoptosis, decreased inflammation,
decreased nitric oxide-mediated injury, increased antioxidant response, decreased axonal
degeneration, and increased protective effects on glia. This is a randomized, masked, placebo
controlled clinical study in which enrolled infants will receive weekly Darbe or placebo
(sham) dosing.

Inclusion Criteria:

- Inborn and outborn preterm infants

- 23 0/7-28 6/7 weeks gestation

- ≤24 hours postnatal age

Exclusion Criteria:

- Hematocrit > 60%

- Infants with known congenital or chromosomal anomalies, including congenital heart
disease and known brain anomalies

- Hemorrhagic or hemolytic disease

- EEG- confirmed seizures

- Congenital thrombotic disease

- Systolic blood pressures >100 mm Hg while not on pressor support

- Receiving Epo or Darbe clinically, or planning to receive Epo or Darbe during
hospitalization

- Infants in whom no aggressive therapy is planned

- Family will NOT be available for follow-up at 22-26 months
We found this trial at
16
sites
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: C. Michael Cotten, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon Tyson, MD, MPH
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Providence, Rhode Island 02905
Principal Investigator: Abbot R Laptook, MD
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Bradley Yoder, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-0180
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD
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Cincinnati, OH
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Eric C Eichenwald, MD
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