Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-04 @ 5:14 PM
Study NCT ID:
NCT03071861
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mild Encephalopathy in the Newborn Treated With Darbepoetin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tara.dupont@hsc.utah.edu', 'phone': '8015814178', 'title': 'Tara DuPont', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'pK analysis has not been completed yet.'}}, 'adverseEventsModule': {'timeFrame': 'birth to 9 months', 'description': 'No subject died during this trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Normal Neurodevelopment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 - 12 months of age', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'one infant was lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Percent of Infants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days or until hospital discharge whichever comes first', 'description': 'Potential adverse events such as (but not limited to) alterations in blood pressure, secondary infections, neutropenia, thrombotic/vascular events, hematologic events (platelets, Hct level, polycythemia), and hepatic/renal function that are outside of normal range for the study population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were NO adverse events reported'}, {'type': 'SECONDARY', 'title': 'Percent of Infants With Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days or until hospital discharge whichever comes first', 'description': 'development of clinical or electrographic seizures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with seizures after study enrolment'}, {'type': 'SECONDARY', 'title': 'Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days or until hospital discharge whichever comes first', 'description': 'Infants who require tube feedings at discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Discharge feeding method'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent With Seizures', 'timeFrame': '24 months of age', 'description': 'development of clinical or electrographic seizures', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent With Failure to Thrive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months of age', 'description': 'Growth at \\<3%', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '27 infants were followed at 9 months of age. One infant in the placebo arm was lost to follow up.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent With Hearing Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months of age', 'description': 'Child requires a hearing device', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'one infant was lost to follow up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent With Vision Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months of age', 'description': 'requires corrective lenses', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'one infant was lost to follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age\n\nDarbepoetin Alfa: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age\n\nNormal Saline: Single dose of normal saline, IV, given at less than 24 hours of age'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '39', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '39', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'gestational age less than 36 weeks', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '13 infants were enrolled in the Darbe arm and 15 were enrolled in the placebo arm'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-18', 'size': 443138, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_007.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-21T19:55', 'hasProtocol': True}, {'date': '2018-12-04', 'size': 279548, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_008.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-21T19:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2016-12-01', 'resultsFirstSubmitDate': '2022-11-23', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-21', 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent With Seizures', 'timeFrame': '24 months of age', 'description': 'development of clinical or electrographic seizures'}, {'measure': 'Percent With Failure to Thrive', 'timeFrame': '9 months of age', 'description': 'Growth at \\<3%'}, {'measure': 'Percent With Hearing Impairment', 'timeFrame': '9 months of age', 'description': 'Child requires a hearing device'}, {'measure': 'Percent With Vision Impairment', 'timeFrame': '9 months of age', 'description': 'requires corrective lenses'}], 'primaryOutcomes': [{'measure': 'Normal Neurodevelopment', 'timeFrame': '9 - 12 months of age', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percent of Infants With Adverse Events', 'timeFrame': '30 days or until hospital discharge whichever comes first', 'description': 'Potential adverse events such as (but not limited to) alterations in blood pressure, secondary infections, neutropenia, thrombotic/vascular events, hematologic events (platelets, Hct level, polycythemia), and hepatic/renal function that are outside of normal range for the study population.'}, {'measure': 'Percent of Infants With Seizures', 'timeFrame': '30 days or until hospital discharge whichever comes first', 'description': 'development of clinical or electrographic seizures'}, {'measure': 'Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home', 'timeFrame': '30 days or until hospital discharge whichever comes first', 'description': 'Infants who require tube feedings at discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['darbepoetin', 'Brain Diseases'], 'conditions': ['Neonatal Encephalopathy', 'Hypoxic-Ischemic Encephalopathy Mild']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Therapeutic hypothermia (TH) is the standard of care for newborns diagnosed with moderate to severe neonatal encephalopathy (NE) presumably due to hypoxic ischemia. In order to be eligible for TH an infant must have perinatal acidemia and evidence of moderate or severe encephalopathy on a standardized neurologic examination (Sarnat). However, the majority of newborns with perinatal acidemia do not have a neurologic examination abnormal enough to be classified as moderate or severe NE. In a retrospective review, DuPont et al. found that as many as 20% of newborns with perinatal academia and mild NE have abnormal short-term outcomes such as seizures, death from progressive asphyxia insult, brain MRI findings consistent with NE, abnormal neurologic examination at discharge, gastrostomy tube feeding, or feeding difficulties. Preliminary data from a prospective trial investigating mild NE (PRIME study, NCT01747863) found that 39% had either abnormal electroencephalography at \\< 9h of age, an abnormal brain MRI finding, or abnormal neurological exam at discharge. Murray et al. recently reported on 5-year outcomes of infants with mild encephalopathy and showed that 25% had neurodevelopmental disability. These data suggest that mild NE likely carries a higher risk of impaired neurological outcome then reported previously. Thus it would appear that neuroprotective strategies would be beneficial in this group of infants. Preliminary data suggest that erythropoiesis stimulating agents (ESA) provide neuroprotection, and improve short and long-term neurologic outcome in neonatal brain injury. ESA may work through several mechanisms including reduced inflammation, limited oxidative stress, decreased apoptosis and white matter injury, as well as via pro-angiogenic and neurogenic properties. Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule has established safety and pharmacokinetics in newborns. Because Darbe has an extended circulating half-life with comparable biological activity to EPO, it has the advantage of requiring less frequent administration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational age \\> 34 weeks by best obstetric estimate, are \\<24 hours old and have evidence of mild encephalopathy as defined by Shankaran et al based on a modified Sarnat examination performed at \\<6 hours of age.\n\n1. History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart rate abnormality, or meconium staining)\n2. Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for TH.\n3. Infant has an IV for clinical treatment\n\nExclusion Criteria:\n\n1. Moderate/Severe encephalopathy on modified Sarnat examination at \\< 6 hours of age\n2. Major congenital and/or chromosomal abnormalities\n3. Prenatal diagnosis of brain abnormality or hydrocephalus\n4. Severe growth restriction (\\< 3%)\n5. Central venous hematocrit \\>65%, platelet count \\>600,000/dL, and/or neutropenia (ANC\\<500 μL)\n6. ECMO\n7. Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist'}, 'identificationModule': {'nctId': 'NCT03071861', 'acronym': 'MEND', 'briefTitle': 'Mild Encephalopathy in the Newborn Treated With Darbepoetin', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Mild Encephalopathy in the Newborn Treated With Darbepoetin (MEND)', 'orgStudyIdInfo': {'id': 'MEND 16-330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darbepoetin Alpha', 'description': 'IV,10 mcg/kg/dose, Darbepoetin Alpha, one dose at \\<24 hours of age', 'interventionNames': ['Drug: Darbepoetin Alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'IV, Normal saline (placebo dose), one dose at \\<24 hours of age', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Darbepoetin Alfa', 'type': 'DRUG', 'otherNames': ['Darbe', 'Darbepoetin'], 'description': 'Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age', 'armGroupLabels': ['Darbepoetin Alpha']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Single dose of normal saline, IV, given at less than 24 hours of age', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Tara L DuPont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}