Hypotension in Neonates



Status:Completed
Conditions:High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:April 2009
End Date:December 2009

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Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study

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).

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.

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
We found this trial at
17
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Providence, RI
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Palo Alto, California 94304
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