Mild Encephalopathy in the Newborn Treated With Darbepoetin

NCT03071861 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MEND 16-330
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants \>34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at less than six hours of age. Participants will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be performed at 24 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.

Conditions

Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy Mild

Keywords

darbepoetin; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• Normal Neurodevelopment

  The Bayley III and Neuromuscular Assessment were completed between 9-12 months of age. Subjects were abnormal if they had a Bayley III score of less than 70 and/or an abnormal neurological examination.

  9 - 12 months of age

Secondary Outcomes (3)

• Percent of Infants With Adverse Events

  30 days or until hospital discharge whichever comes first

• Percent of Infants With Seizures

  30 days or until hospital discharge whichever comes first

• Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home

  30 days or until hospital discharge whichever comes first

Other Outcomes (4)

• Percent With Seizures

  24 months of age

• Percent With Failure to Thrive

  9 months of age

• Percent With Hearing Impairment

  9 months of age

Study Arms (2)

Darbepoetin Alpha

EXPERIMENTAL

IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \<24 hours of age

Drug: Darbepoetin Alfa

Placebo

PLACEBO COMPARATOR

IV, Normal saline (placebo dose), one dose at \<24 hours of age

Drug: Normal Saline

Interventions

Darbepoetin Alfa DRUG

Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age

Also known as: Darbe, Darbepoetin

Darbepoetin Alpha

Normal Saline DRUG

Single dose of normal saline, IV, given at less than 24 hours of age

Placebo

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart rate abnormality, or meconium staining)
• Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for TH.
• Infant has an IV for clinical treatment

You may not qualify if:

• Moderate/Severe encephalopathy on modified Sarnat examination at \< 6 hours of age
• Major congenital and/or chromosomal abnormalities
• Prenatal diagnosis of brain abnormality or hydrocephalus
• Severe growth restriction (\< 3%)
• Central venous hematocrit \>65%, platelet count \>600,000/dL, and/or neutropenia (ANC\<500 μL)
• ECMO
• Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

Sponsors & Collaborators

• University of New Mexico: lead
• University of Utah: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

Darbepoetin alfa; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

pK analysis has not been completed yet.

Results Point of Contact

• Title: Tara DuPont
• Organization: University of Utah

tara.dupont@hsc.utah.edu

8015814178

Study Officials

• Tara L DuPont, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: March 7, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2022
• Last Updated: December 21, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)