Purpose

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

Conditions

Eligibility

Eligible Ages
Between 23 Weeks and 28 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, masked, placebo-controlled trial
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Primary providers and bedside caregivers will be blinded to randomization group. If the dose will be administered IV, the study drug will be administered slow IV push by the bedside nurse. If the dose will be administered subcutaneously, the study drug will be brought to the bedside in a closed container, and injections will be shielded behind screens and out of earshot from caregivers and parents. An adhesive bandage (or 2x2 gauze) will be placed over the true and sham injection sites and either taped or held in place until no evidence of the injection is visible. The parents, medical providers, data collection staff and neurodevelopmental follow up personnel will be masked to the treatment arm.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Darbepoetin
Darbepoetin 10 micrograms/kg/once every week (IV or SC)
  • Drug: Darbepoetin
    Darbepoetin 10 micrograms/kg/once every week (IV or SC). Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
    Other names:
    • Darbe
Placebo Comparator
Placebo
Equal volume normal saline for IV administration, or sham dosing
  • Drug: Placebo
    normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
    Other names:
    • normal saline for IV administration, or sham dosing

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Waldemar A. Carlo, MD

More Details

NCT ID
NCT03169881
Status
Recruiting
Sponsor
NICHD Neonatal Research Network

Study Contact

Robin Ohls, MD
801-581-7052
robin.ohls@hsc.utah.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.