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Erythropoiesis-Stimulating Agent

Darbepoetin for Neurodevelopmental Disorder (Darbe Trial)

Phase 3

Waitlist Available

Led By Robin Ohls, MD

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≤24 hours postnatal age

Inborn and outborn preterm infants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 months corrected age

Awards & highlights

Darbe Trial Summary

This trial will test whether Darbe can help improve cognitive outcomes for preterm infants.

Who is the study for?

This trial is for preterm infants born between 23 and nearly 29 weeks of gestation, who are less than one day old. It's not for babies with genetic or heart defects, brain anomalies, high blood count, seizures, clotting disorders, very high blood pressure without medication support, or if they're already getting similar treatments.Check my eligibility

What is being tested?

The study tests whether giving Darbepoetin (Darbe) to premature babies weekly can improve their brain development and cognitive skills by the time they're about two years old. They'll compare results from babies given Darbe against those given a placebo.See study design

What are the potential side effects?

While specific side effects in this context aren't detailed here, generally Darbepoetin may cause reactions at the injection site, elevated blood pressure, and rare cases of serious allergic reactions.

Darbe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby is less than 24 hours old.

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My baby was born prematurely.

Darbe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite cognitive score on Bayley Scale of Infant Development III

Secondary outcome measures

Bronchopulmonary dysplasia (BPD)

Cerebral Palsy

Culture positive sepsis

+13 more

Darbe Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DarbepoetinExperimental Treatment1 Intervention

Darbepoetin 10 micrograms/kg/once every week (IV or SC)

Group II: PlaceboPlacebo Group1 Intervention

Equal volume normal saline for IV administration, or sham dosing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Darbepoetin

2014

Completed Phase 2

~170

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,832 Previous Clinical Trials

47,305,696 Total Patients Enrolled

NICHD Neonatal Research NetworkLead Sponsor

59 Previous Clinical Trials

205,120 Total Patients Enrolled

Robin Ohls, MDPrincipal InvestigatorUniversity of Utah

2 Previous Clinical Trials

80,007 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different hospitals is this trial being conducted?

"There are many enrolling locations for this clinical trial, these include but are not limited to: Stanford University in Palo Alto, University of Rochester in Rochester and the University of Texas Health Science Center at Houston."

Answered by AI

Are new participants being accepted into this clinical trial?

"Presently, this clinical trial is not recruiting patients. This study was originally posted on September 20th, 2017 and was last updated on September 26th, 2022. There are 4 other trials for neurocognitive disorders enrolling patients and 6 Darbepoetin studies with open recruitment at the moment."

Answered by AI

How many individuals are actively participating in this clinical trial?

"Unfortunately, this study is not currently recruiting patients. However, it is still an active trial, as shown by the most recent update on September 26th, 2022. If you are seeking other trials to join, there are 4 studies related to neurocognitive disorders and 6 for Darbepoetin that have open enrolment at this time."

Answered by AI

Has Darbepoetin been federally recognized in the USA?

"There is both animal and human data supporting Darbepoetin's safety, so it received a score of 3."

Answered by AI

Does this research require that participants be under a certain age?

"According to the specific requirements for this research, patients must be 23-28 weeks old."

Answered by AI

How can I sign up for this research project?

"This trial is only admitting 650 patients that fit the neurocognitive and age criteria of 23 weeks to 28 weeks."

Answered by AI

What is the general success rate of Darbepoetin in clinical trials?

"The medication known as darbepoetin was first studied in 2004 at St Bartholomew's Hospital. So far, there have been 18384 completed studies and 6 trials are still ongoing. The majority of these live clinical trials are based out of Palo Alto, California."

Answered by AI

Recent research and studies

Pediatric ResearchJournal

Transfusions and Neurodevelopmental Outcomes in Extremely Low Gestation Neonates Enrolled in the PENUT Trial: A Randomized Clinical Trial

Vu, Phuong T., Robin K. Ohls, Dennis E. Mayock, Kendell R. German, Bryan A. Comstock, Patrick J. Heagerty, Sandra E. Juul, et al.. 2021. “Transfusions and Neurodevelopmental Outcomes in Extremely Low Gestation Neonates Enrolled in the PENUT Trial: A Randomized Clinical Trial”. Pediatric Research. Springer Science and Business Media LLC. doi:10.1038/s41390-020-01273-w.

clinicaltrials.govStudy

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

2017. "Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03169881.