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Early Blood Pressure Management in Extremely Premature Infants (ELGAN BP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00874393
First received: April 1, 2009
Last updated: April 30, 2013
Last verified: January 2013
  Purpose

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:

  • dopamine and hydrocortisone
  • dopamine and normal saline
  • dextrose and hydrocortisone
  • dextrose and normal saline.

In 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.


Condition Intervention
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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Enrollment and completion of 60 infants [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 1 week and prior to hospital discharge ] [ Designated as safety issue: Yes ]
  • Duration of antihypotensive therapy [ Time Frame: First 96 postnatal hours ] [ Designated as safety issue: Yes ]
  • Receipt and timing of medical and/or surgical therapy for a PDA [ Time Frame: To hospital discharge ] [ Designated as safety issue: Yes ]
  • Use of open-label antihypotensive therapies (inotropes, corticosteroids, blood and plasma volume expanders) for persistently low BP with biochemical evidence of poor perfusion [ Time Frame: First 96 postnatal hours ] [ Designated as safety issue: Yes ]
  • Spontaneous gastrointestinal perforation [ Time Frame: First 7 days ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: To hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dopamine and hydrocortisone
Dopamine AND hydrocortisone
Drug: Dopamine
Dopamine
Drug: Hydrocortisone
Hydrocortisone
Active Comparator: Dopamine and placebo
Dopamine AND normal saline placebo
Drug: Dopamine
Dopamine
Drug: Syringe Placebo
Normal saline
Active Comparator: Placebo and hydrocortisone
Dextrose (D5W) placebo AND hydrocortisone
Drug: Hydrocortisone
Hydrocortisone
Drug: Infusion Placebo
Dextrose (D5W)
Placebo Comparator: Placebo and Placebo
Dextrose (D5W) placebo AND normal saline placebo
Drug: Infusion Placebo
Dextrose (D5W)
Drug: Syringe Placebo
Normal saline

Detailed Description:

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 for this trial.

In 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.

Based on slow rate of recruitment, a time-limited observational study of hypotension in ELBW infants has been added to the current study.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inborn infants
  • 23 0/7 to 26 6/7 weeks estimated gestational age
  • Umbilical arterial catheter in place at study entry
  • <= 24 hours of age

Exclusion Criteria:

  • Terminally ill infants
  • Infants that have received (prior to enrollment): >20 ml/kg in fluid boluses, indomethacin, or ibuprofen
  • Infants with major congenital anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874393

Locations
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, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
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
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Investigators
Principal Investigator: Beau J. Batton, MD 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
Principal Investigator: Edward F. Bell, MD University of Iowa
Principal Investigator: Abbot R. Laptook, MD Brown University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Brenda P. Poindexter, MD MS Indiana University
Principal Investigator: Kurt Schibler, MD Cincinnati Children's Medical Center
Principal Investigator: Kathleen A. Kennedy, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Pablo J. Sanchez, MD University of Texas
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Ivan D. Franz III, MD Tufts University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00874393     History of Changes
Other Study ID Numbers: NICHD-NRN-0041, U10HD021364, U10HD027880, U10HD034216, U10HD036790, U10HD040492, U10HD053089, U10HD053124, UL1RR025744, UL1RR025764, UL1RR025777, M01RR000064, M01RR000070, U10HD027904, U10HD027853, U10HD040689, U10HD027851, UL1RR025008, U10HD021373, U10HD027856, U10HD053109, UL1RR024979, U10HD053119, UL1RR025747, U10HD021385, U10HD027871, UL1RR024139
Study First Received: April 1, 2009
Last Updated: April 30, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Blood Pressure Management
Dopamine
Hydrocortisone

Additional relevant MeSH terms:
Birth Weight
Hypotension
Body Weight
Cardiovascular Diseases
Signs and Symptoms
Vascular Diseases
Cortisol succinate
Dopamine
Dopamine Agents
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014