Hypotension in Neonates
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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: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study |
- Prevalence of Hypotension in infants [ Time Frame: < 72 hours of age until hospital discharge ] [ Designated as safety issue: No ]
- Management of hypotension in infants [ Time Frame: < 72 hours of age through resolution of hypotension ] [ Designated as safety issue: No ]
- Short-term outcomes, including: vasopressor/inotrope exposure, death, time to full nipple feedings, duration of ventilation, and length of NICU stay [ Time Frame: < 72 hours of age until hospital discharge ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | April 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 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:
- ≥34 0/7 weeks gestational age
- Intubated and mechanically ventilated within 72 hours of postnatal age
Exclusion Criteria:
- major congenital heart disease
- acute hypotension resulting directly from known acute maternal and/or fetal hemorrhage within 24 hours prior to delivery
- pituitary hypoplasia
- congenital adrenal hyperplasia
- known chromosomal disorders
Contacts and 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 | |
| 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 | Cincinnati Children's Medical Center |
| 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
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00882284 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0040, U10HD021364, U10HD021373, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD040492, U10HD040689, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024139, UL1RR025744, M01RR008084 |
| Study First Received: | April 1, 2009 |
| Last Updated: | November 4, 2011 |
| 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 Blood Pressure Management |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013