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Hypotension in Neonates

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ClinicalTrials.gov Identifier: NCT00882284
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Brief Summary:
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 or disease
Infant, Newborn Hypotension Blood Pressure

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of Hypotension in infants [ Time Frame: < 72 hours of age until hospital discharge ]

Secondary Outcome Measures :
  1. Management of hypotension in infants [ Time Frame: < 72 hours of age through resolution of hypotension ]
  2. 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 ]


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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

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): NCT00882284


Locations
Show Show 17 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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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 Children's Hospital Medical Center, 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
Additional Information:
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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00882284    
Other Study ID Numbers: NICHD-NRN-0040
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Blood Pressure Management
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases