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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00882284 |
Purpose
This observational study collects information on the current incidence and management of hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research Network (NRN). Participants include all newborn infants born at 34 0/7 weeks gestation or greater who are admitted to NICU Network centers and intubated and mechanically ventilated at less than 72 hours of age. The information gathered will provide a framework for the design of a potential randomized controlled trial for the treatment of hypotension in neonates.
This observational study is for a time-limited enrollment period of 4-6 months; NRN centers will continue to enroll until at least 50 patients are enrolled per center (for approximately 800-1,000 subjects total).
| Condition |
|---|
|
Infant, Newborn Hypotension Blood Pressure |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study |
| Estimated Enrollment: | 1000 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
An estimated 30-50 percent of infants born at or near term who require ventilation for respiratory failure also receive therapy for hypotension and associated clinical instability, such as poor urine output, poor circulation to the tissues, and metabolic acidosis (a pH imbalance in which the body accumulates too much acid). Emerging evidence, although limited, suggests that the underlying cause of hypotension in many of these infants is that their adrenal glands do not produce adequate amounts of cortisol. This observational study is to determine the current incidence and management of hypotension in infants born at least 34 0/7 weeks gestation who are intubated and mechanically ventilated at less than 72 hours of age. The goal is to define a target population for a potential randomized controlled trial for the treatment of hypotension in such infants. In this study, 16 NICHD Neonatal Research Network centers are enrolling at least 50 infants each, collecting basic demographic and baseline data on the mother and baby. In those infants treated for hypotension, data is collected on the dose, duration, and type of therapy, age and blood pressure at the time therapy is started, and the indication for the therapy.
Eligibility| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All newborn infants born at ≥34 0/7 weeks gestational age admitted to NICU Network centers who are intubated and mechanically ventilated within 72 hours of postnatal age
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Erika Fernandez, MD | (505) 272-6753 | efernandez@salud.unm.edu |
| Contact: Rosemary D Higgins, MD | 301-496-5575 | 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, 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 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
| Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island |
| 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: | Barbara J Stoll, MD | Emory University |
| Principal Investigator: | Brenda B Poindexter, MD MS | Indiana University |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University |
| Principal Investigator: | Ivan D Frantz III, MD | Tufts Medical Center |
| Principal Investigator: | Kurt Schibler, MD | University of Cincinnati |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Edward F Bell, MD | University of Iowa |
| Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico |
| Principal Investigator: | Pablo J Sanchez, MD | University of Texas Southwestern Medical Center at Dallas |
| Principal Investigator: | Kathleen A Kennedy, MD MPH | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Roger G Faix, MD | University of Utah |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
| Principal Investigator: | Richard A Ehrenkranz, MD | Yale University |
More Information
| Responsible Party: | University of New Mexico ( Erika Fernandez, MD, Study Principal Investigator ) |
| Study ID Numbers: | NICHD-NRN-0038, U10 HD21364 (Case), U10 HD21373 (Houston), U10 HD21385 (Wayne), U10 HD27851 (Emory), U10 HD27853 (Cincinnati), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27904 (Brown), U10 HD34216 (Alabama), U10 HD40492 (Duke), U10 HD40689 (Dallas), U10 HD53089 (UNM), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah), CTSA UL1 RR24139 (Yale), CTSA UL1 RR25744 (Stanford), CTSA UL1 RR25764 (Utah), CTSA UL1 RR25777 (Alabama), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR750 (Indiana), GCRC M01 RR8084 (Cincinnati) |
| Study First Received: | April 1, 2009 |
| Last Updated: | April 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00882284 History of Changes |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
NICHD Neonatal Research Network Blood Pressure Management |
|
Hypotension Hydrocortisone Cortisol succinate Vascular Diseases Hydrocortisone acetate |
|
Hypotension Vascular Diseases Cardiovascular Diseases |
