Early Blood Pressure Management in Extremely Premature Infants (ELGAN BP)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00874393 |
|
Recruitment Status :
Completed
First Posted : April 2, 2009
Last Update Posted : May 25, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
- Enrollment and completion of 60 infants [ Time Frame: 1 year ]
- Death [ Time Frame: 1 week and prior to hospital discharge ]
- Duration of antihypotensive therapy [ Time Frame: First 96 postnatal hours ]
- Receipt and timing of medical and/or surgical therapy for a PDA [ Time Frame: To hospital discharge ]
- 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 ]
- Spontaneous gastrointestinal perforation [ Time Frame: First 7 days ]
- 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 ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 24 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874393
Show 17 study locations
| 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 | Children's Hospital Medical Center, Cincinnati | |
| 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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|
NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity |
Blood Pressure Management Dopamine Hydrocortisone |
|
Premature Birth Hypotension Birth Weight Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Vascular Diseases Cardiovascular Diseases Body Weight Hydrocortisone Dopamine |
Anti-Inflammatory Agents Cardiotonic Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |