Status:
COMPLETED
Early Blood Pressure Management in Extremely Premature Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
Brief Summary
This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusio...
Detailed Description
Since most extremely preterm infants are critically ill in the immediate postnatal period, establishing "normal" blood pressure (BP) values is difficult. This lack of data makes deciding when to insti...
Eligibility Criteria
Inclusion
- Inborn infants
- 23 0/7 to 26 6/7 weeks estimated gestational age
- Umbilical arterial catheter in place at study entry
- \<= 24 hours of age
Exclusion
- Terminally ill infants
- Infants that have received (prior to enrollment): \>20 ml/kg in fluid boluses, indomethacin, or ibuprofen
- Infants with major congenital anomalies
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00874393
Start Date
July 1 2009
End Date
December 1 2011
Last Update
May 25 2017
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
Yale University
New Haven, Connecticut, United States, 06504
4
Emory University
Atlanta, Georgia, United States, 30303