Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT00874393
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Blood Pressure Management in Extremely Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004298', 'term': 'Dopamine'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment and completion of 60 infants', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '1 week and prior to hospital discharge'}, {'measure': 'Duration of antihypotensive therapy', 'timeFrame': 'First 96 postnatal hours'}, {'measure': 'Receipt and timing of medical and/or surgical therapy for a PDA', 'timeFrame': 'To hospital discharge'}, {'measure': 'Use of open-label antihypotensive therapies (inotropes, corticosteroids, blood and plasma volume expanders) for persistently low BP with biochemical evidence of poor perfusion', 'timeFrame': 'First 96 postnatal hours'}, {'measure': 'Spontaneous gastrointestinal perforation', 'timeFrame': 'First 7 days'}, {'measure': 'In-hospital complications (grade III or IV intraventricular hemorrhage, cystic periventricular leukomalacia, necrotizing enterocolitis requiring surgical intervention, retinopathy of prematurity requiring laser surgery, or bronchopulmonary dysplasia)', 'timeFrame': 'To hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NICHD Neonatal Research Network', 'Very Low Birth Weight (VLBW)', 'Extremely Low Birth Weight (ELBW)', 'Prematurity', 'Blood Pressure Management', 'Dopamine', 'Hydrocortisone'], 'conditions': ['Infant, Newborn', 'Infant, Low Birth Weight', 'Infant, Small for Gestational Age', 'Infant, Premature', 'Hypotension', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '22336574', 'type': 'RESULT', 'citation': 'Batton BJ, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Van Meurs KP, Carlo WA, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Feasibility study of early blood pressure management in extremely preterm infants. J Pediatr. 2012 Jul;161(1):65-9.e1. doi: 10.1016/j.jpeds.2012.01.014. Epub 2012 Feb 14.'}, {'pmid': '26567120', 'type': 'DERIVED', 'citation': "Batton B, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Stoll BJ, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health & Human Development Neonatal Research Network. Early blood pressure, antihypotensive therapy and outcomes at 18-22 months' corrected age in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2016 May;101(3):F201-6. doi: 10.1136/archdischild-2015-308899. Epub 2015 Nov 13."}, {'pmid': '23650301', 'type': 'DERIVED', 'citation': 'Batton B, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Stoll BJ, Van Meurs KP, Carlo WA, Poindexter BB, Bell EF, Sanchez PJ, Ehrenkranz RA, Goldberg RN, Laptook AR, Kennedy KA, Frantz ID 3rd, Shankaran S, Schibler K, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health & Human Development Neonatal Research Network. Use of antihypotensive therapies in extremely preterm infants. Pediatrics. 2013 Jun;131(6):e1865-73. doi: 10.1542/peds.2012-2779. Epub 2013 May 6.'}], 'seeAlsoLinks': [{'url': 'https://neonatal.rti.org/', 'label': 'NICHD Neonatal Research Network'}]}, 'descriptionModule': {'briefSummary': 'This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo).\n\nEnrolled infants will be randomized to receive one of the following drug pairs:\n\n* dopamine and hydrocortisone\n* dopamine and normal saline\n* dextrose and hydrocortisone\n* dextrose and normal saline.\n\nIn addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.', 'detailedDescription': 'Since most extremely preterm infants are critically ill in the immediate postnatal period, establishing "normal" blood pressure (BP) values is difficult. This lack of data makes deciding when to institute therapy for hypotension (low BP) challenging, leading to considerable variability in BP management in neonatal intensive care units (NICUs). Despite a lack of data on safety or efficacy, as many as 64% of extremely preterm infants receive inotropes (e.g., dopamine), and up to 12.4% of very low birthweight infants receive hydrocortisone for perceived hypotension. Since both untreated low BP and therapy provided for low BP may be harmful, the decision of whether to treat is an important issue. To date, no prospective randomized, controlled trial of BP management in this population has been performed.\n\nThis trial tests the feasibility of enrolling up to 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. It will enroll 60 infants between 23 0/7 and 26 6/7 weeks gestational age born at 6 participating NICHD Neonatal Research Network sites. Eligible infants will receive a study infusion drug (dopamine or a dextrose placebo) and a study syringe drug (hydrocortisone or a normal saline placebo). Infants will be randomized to receive one of the following drug pairs: (1) dopamine and hydrocortisone; (2) dopamine and a placebo (normal saline solution); (3) a placebo (dextrose) and hydrocortisone; or (4) placebo (dextrose) and placebo (normal saline). (NOTE: dopamine is normally mixed with dextrose and hydrocortisone is mixed with saline solution before being administered, which is why two different placebos are being used in this trial.)\n\nThe information gathered will provide a framework for the design of a potential larger, multi-centered, randomized control trial.\n\nNOTE: The NICHD Neonatal Research Network has received a FDA exemption from the IND regulations for this trial.\n\nIn addition to the interventional trial above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.\n\nBased on slow rate of recruitment, a time-limited observational study of hypotension in ELBW infants has been added to the current study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn infants\n* 23 0/7 to 26 6/7 weeks estimated gestational age\n* Umbilical arterial catheter in place at study entry\n* \\<= 24 hours of age\n\nExclusion Criteria:\n\n* Terminally ill infants\n* Infants that have received (prior to enrollment): \\>20 ml/kg in fluid boluses, indomethacin, or ibuprofen\n* Infants with major congenital anomalies'}, 'identificationModule': {'nctId': 'NCT00874393', 'acronym': 'ELGAN BP', 'briefTitle': 'Early Blood Pressure Management in Extremely Premature Infants', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0041'}, 'secondaryIdInfos': [{'id': 'U10HD021364', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021364', 'type': 'NIH'}, {'id': 'U10HD027880', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027880', 'type': 'NIH'}, {'id': 'U10HD034216', 'link': 'https://reporter.nih.gov/quickSearch/U10HD034216', 'type': 'NIH'}, {'id': 'U10HD036790', 'link': 'https://reporter.nih.gov/quickSearch/U10HD036790', 'type': 'NIH'}, {'id': 'U10HD040492', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040492', 'type': 'NIH'}, {'id': 'U10HD053089', 'link': 'https://reporter.nih.gov/quickSearch/U10HD053089', 'type': 'NIH'}, {'id': 'U10HD053124', 'link': 'https://reporter.nih.gov/quickSearch/U10HD053124', 'type': 'NIH'}, {'id': 'UL1RR025744', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR025744', 'type': 'NIH'}, {'id': 'UL1RR025764', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR025764', 'type': 'NIH'}, {'id': 'UL1RR025777', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR025777', 'type': 'NIH'}, {'id': 'U10HD027904', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027904', 'type': 'NIH'}, {'id': 'U10HD027853', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027853', 'type': 'NIH'}, {'id': 'U10HD040689', 'link': 'https://reporter.nih.gov/quickSearch/U10HD040689', 'type': 'NIH'}, {'id': 'U10HD027851', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027851', 'type': 'NIH'}, {'id': 'UL1RR025008', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR025008', 'type': 'NIH'}, {'id': 'U10HD021373', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021373', 'type': 'NIH'}, {'id': 'U10HD027856', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027856', 'type': 'NIH'}, {'id': 'U10HD053109', 'link': 'https://reporter.nih.gov/quickSearch/U10HD053109', 'type': 'NIH'}, {'id': 'UL1RR024979', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024979', 'type': 'NIH'}, {'id': 'U10HD053119', 'link': 'https://reporter.nih.gov/quickSearch/U10HD053119', 'type': 'NIH'}, {'id': 'UL1RR025747', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR025747', 'type': 'NIH'}, {'id': 'U10HD021385', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021385', 'type': 'NIH'}, {'id': 'U10HD027871', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027871', 'type': 'NIH'}, {'id': 'UL1RR024139', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024139', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dopamine and hydrocortisone', 'description': 'Dopamine AND hydrocortisone', 'interventionNames': ['Drug: Dopamine', 'Drug: Hydrocortisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dopamine and placebo', 'description': 'Dopamine AND normal saline placebo', 'interventionNames': ['Drug: Dopamine', 'Drug: Syringe Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo and hydrocortisone', 'description': 'Dextrose (D5W) placebo AND hydrocortisone', 'interventionNames': ['Drug: Hydrocortisone', 'Drug: Infusion Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Placebo', 'description': 'Dextrose (D5W) placebo AND normal saline placebo', 'interventionNames': ['Drug: Infusion Placebo', 'Drug: Syringe Placebo']}], 'interventions': [{'name': 'Dopamine', 'type': 'DRUG', 'description': 'Dopamine', 'armGroupLabels': ['Dopamine and hydrocortisone', 'Dopamine and placebo']}, {'name': 'Hydrocortisone', 'type': 'DRUG', 'description': 'Hydrocortisone', 'armGroupLabels': ['Dopamine and hydrocortisone', 'Placebo and hydrocortisone']}, {'name': 'Infusion Placebo', 'type': 'DRUG', 'description': 'Dextrose (D5W)', 'armGroupLabels': ['Placebo and Placebo', 'Placebo and hydrocortisone']}, {'name': 'Syringe Placebo', 'type': 'DRUG', 'description': 'Normal saline', 'armGroupLabels': ['Dopamine and placebo', 'Placebo and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'RTI International', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University, Women & Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Beau J. Batton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Case Western Reserve University, Rainbow Babies and Children's Hospital"}, {'name': 'Ronald N. Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Krisa P. Van Meurs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Waldemar A Carlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Kristi L. Watterberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}, {'name': 'Roger G. Faix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}, {'name': 'Abhik Das, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}, {'name': 'Edward F. Bell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Abbot R. Laptook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}, {'name': 'Barbara J. Stoll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Brenda P. Poindexter, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Kurt Schibler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Kathleen A. Kennedy, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Pablo J. Sanchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}, {'name': 'Seetha Shankaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}, {'name': 'Richard A. Ehrenkranz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Ivan D. Franz III, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}