Trial · NCT03169881

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

NCT03169881, Phase 3, Completed, NICHD Neonatal Research Network; results first posted 2024-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants. Trials, record NCT03169881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03169881

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
NCT number: NCT03169881
Status: Completed
Phases: Phase 3
Enrollment: 650 participants, actual
Lead sponsor: NICHD Neonatal Research Network
Conditions: Neurocognitive, Neuroprotective, Neonatal, Neurodevelopmental Impairment
Interventions: Darbepoetin, Placebo
First posted: 2017-05-30
Last updated: 2026-07-01
Results first posted: 2024-10-30

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Bayley III Composite Cognitive Score	22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier	Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score \< 85); 2 standard deviations below the mean, moderate delay (score \< 70); and 3 standard deviations below the mean, severe delay (score \< 55). This self-standing scale comprises the primary outcome for the Darbe study.
Secondary	Number of Transfusions Per Infant	Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)	The number of transfusions recorded during the study, up to 35 completed weeks gestational age
Secondary	Total Volume of Transfusions Per Infant	Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)	The total volume of transfusions for the infant if ever transfused
Secondary	Number of Donor Exposures Per Infant	Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)	The number of donor exposures recorded during the study, up to 35 completed weeks gestational age
Secondary	Hematocrit	at 2 and at 7 weeks in the study	Hematocrit adjusted for center, gestational age group, and familial clustering
Secondary	Red Cell Mass	at 2 and at 7 weeks in the study	Red Cell Mass (Circulating Erythrocyte Volume), adjusted for center, gestational age group, and familial clustering
Secondary	Necrotizing Enterocolitis, Bells Stage >=2 With Surgery	Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)	This is measured as Yes if experienced necrotizing enterocolitis, Bells stage \>=2 with surgery; Otherwise, No.
Secondary	Bronchopulmonary Dysplasia Grades 2 or 3	At 36 weeks postmenstrual age	This is measured as Yes if infant is on invasive mechanical ventilation, nasal cannula \>2 L/min or noninvasive positive airway pressure at 36 weeks of postmenstrual age; Otherwise, No.
Secondary	Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received	Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)	This is measured as Yes if experienced Retinopathy of prematurity stage \>=3 or treatment for that condition received; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.
Secondary	Intraventricular Hemorrhage Grade I+	Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)	This is measured as Yes if experienced Grade I+ Intraventricular Hemorrhage; Otherwise, No.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Bayley III Composite Cognitive Score	22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier	The analysis population includes all randomized infants with available data up to the two-year followup.	score on a scale	MEAN
SECONDARY	Number of Transfusions Per Infant	Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)	The analysis population includes all randomized infants with available data during the initial hospitalization.	Transfusions	MEAN
SECONDARY	Total Volume of Transfusions Per Infant	Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)	The analysis population includes all randomized infants that were ever transfused.	mL	MEAN
SECONDARY	Number of Donor Exposures Per Infant	Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)	The analysis population includes all randomized infants with available data during the initial hospitalization.	Donors	MEAN
SECONDARY	Hematocrit	at 2 and at 7 weeks in the study	The analysis population includes all randomized infants with available data during the initial hospitalization.	Percent of blood volume made up of RBCs	LEAST_SQUARES_MEAN
SECONDARY	Red Cell Mass	at 2 and at 7 weeks in the study	The analysis population includes all randomized infants with available data during the initial hospitalization.	mL	LEAST_SQUARES_MEAN
SECONDARY	Necrotizing Enterocolitis, Bells Stage >=2 With Surgery	Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)	The analysis population includes all randomized infants with available data during the initial hospitalization.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Bronchopulmonary Dysplasia Grades 2 or 3	At 36 weeks postmenstrual age	The analysis population includes all randomized infants with available data during the initial hospitalization.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received	Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)	The analysis population includes all randomized infants with available data during the initial hospitalization.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intraventricular Hemorrhage Grade I+	Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)	The analysis population includes all randomized infants with available data during the initial hospitalization.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Bayley III Composite Cognitive Score	Darbepoetin		80.7	Standard Deviation 19.5	score on a scale
Bayley III Composite Cognitive Score	Placebo		80.1	Standard Deviation 18.7	score on a scale
Number of Transfusions Per Infant	Darbepoetin		2.3	Standard Deviation 3.1	Transfusions
Number of Transfusions Per Infant	Placebo		3.3	Standard Deviation 3.5	Transfusions
Total Volume of Transfusions Per Infant	Darbepoetin		54.5	Standard Deviation 51.9	mL
Total Volume of Transfusions Per Infant	Placebo		69.0	Standard Deviation 51.0	mL
Number of Donor Exposures Per Infant	Darbepoetin		1.6	Standard Deviation 2.3	Donors
Number of Donor Exposures Per Infant	Placebo		2.2	Standard Deviation 2.3	Donors
Hematocrit	Darbepoetin	week 2	36.84	95% Confidence Interval 36.35 to 37.33	Percent of blood volume made up of RBCs
Hematocrit	Placebo	week 2	33.88	95% Confidence Interval 33.4 to 34.36	Percent of blood volume made up of RBCs

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Darbepoetin	322
Overall Study	STARTED	Placebo	328
Overall Study	Completed Assessment for Bayley Cognitive Score at Two-Year Follow-Up	Darbepoetin	239
Overall Study	Completed Assessment for Bayley Cognitive Score at Two-Year Follow-Up	Placebo	239
Overall Study	Died After Hospital Discharge	Darbepoetin	2
Overall Study	Died After Hospital Discharge	Placebo	3
Overall Study	Died Before Hospital Discharge	Darbepoetin	50
Overall Study	Died Before Hospital Discharge	Placebo	50
Overall Study	Started Study Drug and Data Not Withdrawn Prior to Hospital Discharge	Darbepoetin	316
Overall Study	Started Study Drug and Data Not Withdrawn Prior to Hospital Discharge	Placebo	325

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events130

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Sepsis neonatal	Infections and infestations	Darbepoetin	16	316	18
other	Sepsis neonatal	Infections and infestations	Placebo	21	325	22
serious	Acute anemia	Blood and lymphatic system disorders	Darbepoetin	1	316	1
serious	Acute anemia	Blood and lymphatic system disorders	Placebo	0	325	0
serious	DIC	Blood and lymphatic system disorders	Darbepoetin	0	316	0
serious	DIC	Blood and lymphatic system disorders	Placebo	1	325	1
serious	Neutropenia	Blood and lymphatic system disorders	Darbepoetin	0	316	0
serious	Neutropenia	Blood and lymphatic system disorders	Placebo	1	325	1
serious	Twin-twin transfusion syndrome	Blood and lymphatic system disorders	Darbepoetin	1	316	1
serious	Twin-twin transfusion syndrome	Blood and lymphatic system disorders	Placebo	0	325	0

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Darbepoetin	52	319
Total, all-cause mortality	Placebo	53	327
Total, other adverse events	Darbepoetin	16	316
Total, other adverse events	Placebo	21	325
Total, serious adverse events	Darbepoetin	85	316
Total, serious adverse events	Placebo	92	325

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33432157	DERIVED	PubMed
37596391	DERIVED	PubMed
40354084	DERIVED	PubMed
41392547	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Darbepoetin vs Placebo: deaths from any cause	Trial comparisons
Darbepoetin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants