Hypotension in Neonates
Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study
20 other identifiers
observational
820
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMarch 22, 2019
March 1, 2019
8 months
April 1, 2009
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of Hypotension in infants
< 72 hours of age until hospital discharge
Secondary Outcomes (2)
Management of hypotension in infants
< 72 hours of age through resolution of hypotension
Short-term outcomes, including: vasopressor/inotrope exposure, death, time to full nipple feedings, duration of ventilation, and length of NICU stay
< 72 hours of age until hospital discharge
Eligibility Criteria
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
You may qualify if:
- ≥34 0/7 weeks gestational age
- Intubated and mechanically ventilated within 72 hours of postnatal age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
RTI International
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 16, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 22, 2019
Record last verified: 2019-03