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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00874393 |
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).
Enrolled infants will be randomized to receive one of the following drug pairs:
Condition | Intervention |
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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Hypotension Blood Pressure |
Drug: Dopamine Drug: Hydrocortisone Drug: Infusion Placebo Drug: Syringe Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Safety Study |
Official Title: | Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study |
Estimated Enrollment: | 60 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dopamine and hydrocortisone: Active Comparator
Dopamine AND hydrocortisone
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Drug: Dopamine
Dopamine
Drug: Hydrocortisone
Hydrocortisone
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Dopamine and placebo: Active Comparator
Dopamine AND normal saline placebo
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Drug: Dopamine
Dopamine
Drug: Syringe Placebo
Normal saline
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Placebo and hydrocortisone: Active Comparator
Dextrose (D5W) placebo AND hydrocortisone
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Drug: Hydrocortisone
Hydrocortisone
Drug: Infusion Placebo
Dextrose (D5W)
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Placebo and Placebo: Placebo Comparator
Dextrose (D5W) placebo AND normal saline placebo
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Drug: Infusion Placebo
Dextrose (D5W)
Drug: Syringe Placebo
Normal saline
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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.
This 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.)
The information gathered will provide a framework for the design of a potential larger, multi-centered, randomized control trial.
NOTE: The NICHD Neonatal Research Network has received a FDA exemption from the IND regulations.
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beau Batton, MD | (216) 844-3387 | bbatton@siumed.edu |
Contact: Rosemary D. Higgins, MD | 301-435-7909 | higginsr@mail.nih.gov |
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
RTI International | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84108 |
Principal Investigator: | Michele C. Walsh, MD MS | Case Western Reserve University, Rainbow Babies and Children's Hospital |
Principal Investigator: | Ronald N. Goldberg, MD | Duke University |
Principal Investigator: | Krisa P. Van Meurs, MD | Stanford University |
Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
Principal Investigator: | Kristi L. Watterberg, MD | University of New Mexico |
Principal Investigator: | Roger G. Faix, MD | University of Utah |
Principal Investigator: | Abhik Das, PhD | RTI International |
Responsible Party: | Case Western Reserve University, Rainbow Babies and Children's Hospital ( Beau Batton, MD, Study Principal Investigator ) |
Study ID Numbers: | NICHD-NRN-0039, U10 HD21364 (Case), U10 HD27880 (Stanford), U10 HD34216 (Alabama), U10 HD36790 (RTI), U10 HD40492 (Duke), U10 HD53089 (New Mexico), U10 HD53124 (Utah), CTSA UL1 RR25744 (Stanford), CTSA UL1 RR25764 (Utah), CTSA UL1 RR25777 (Alabama), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford) |
Study First Received: | April 1, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00874393 History of Changes |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity |
Blood Pressure Management Dopamine Hydrocortisone |
Anti-Inflammatory Agents Hypotension Birth Weight Neurotransmitter Agents Hydrocortisone Cortisol succinate Vascular Diseases |
Cardiovascular Agents Body Weight Signs and Symptoms Dopamine Dopamine Agents Hydrocortisone acetate Peripheral Nervous System Agents |
Anti-Inflammatory Agents Birth Weight Hypotension Neurotransmitter Agents Hydrocortisone Molecular Mechanisms of Pharmacological Action Cortisol succinate Sympathomimetics Cardiotonic Agents Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents |
Protective Agents Pharmacologic Actions Body Weight Signs and Symptoms Dopamine Autonomic Agents Therapeutic Uses Cardiovascular Diseases Dopamine Agents Peripheral Nervous System Agents Hydrocortisone acetate |