Phase 3
N=650
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Neurocognitive · Neuroprotective · Neonatal · Neurodevelopmental Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03169881 ↗Enrolled (actual)
650
Serious AEs
27.6%
Results posted
Oct 2024
Primary outcome: Primary: Bayley III Composite Cognitive Score — 80.7; 80.1 score on a scale — p=0.88
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darbepoetin (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bayley III Composite Cognitive Score |
80.7; 80.1 | 0.88 |
| SECONDARY Number of Transfusions Per Infant |
2.3; 3.3 | — |
| SECONDARY Total Volume of Transfusions Per Infant |
54.5; 69.0 | — |
| SECONDARY Number of Donor Exposures Per Infant |
1.6; 2.2 | — |
| SECONDARY Hematocrit |
36.84; 33.88; 37.02; 31.78 | — |
| SECONDARY Red Cell Mass |
28.35; 24.74; 42.78; 36.01 | — |
| SECONDARY Necrotizing Enterocolitis, Bells Stage >=2 With Surgery |
14; 13; 305; 314 | — |
| SECONDARY Bronchopulmonary Dysplasia Grades 2 or 3 |
91; 128; 170; 149 | — |
| SECONDARY Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received |
238; 234; 35; 45 | — |
| SECONDARY Intraventricular Hemorrhage Grade I+ |
108; 98; 207; 220 | — |
| SECONDARY Length of Hospital Stay |
96.2; 104.8 | — |
| SECONDARY Death |
52; 53; 267; 274 | — |
| SECONDARY Neurodevelopmental Impairment |
72; 68; 1; 3; 121; 124 | — |
| SECONDARY Any Cerebral Palsy |
40; 38; 204; 209 | — |
Summary
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Eligibility Criteria
Inclusion Criteria
- Inborn and outborn preterm infants
- 23 0/7-28 6/7 weeks gestational age
- ≤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
Data sourced from ClinicalTrials.gov (NCT03169881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.