Hydrocortisone for Term Hypotension

PHASE3CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 19, 2014

Primary Completion Date

March 20, 2018

Study Completion Date

March 20, 2018

Conditions
Infant, Newborn, DiseasesCardiovascular Insufficiency
Interventions
DRUG

Hydrocortisone

"• 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"

DRUG

Placebo

"7 days of intravenous or intramuscular placebo (normal saline in equal volume)~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"

Trial Locations (18)

14642

University of Rochester, Rochester

19104

University of Pennsylvania, Philadelphia

27705

RTI International, Durham

27710

Duke University, Durham

30303

Emory University, Atlanta

35233

University of Alabama at Birmingham, Birmingham

43205

Research Institute at Nationwide Children's Hospital, Columbus

44106

Case Western Reserve University, Cleveland

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

52242

University of Iowa, Iowa City

64108

Children's Mercy Hospital, Kansas City

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

University of Texas Health Science Center at Houston, Houston

87131

University of New Mexico, Albuquerque

90025

University of California - Los Angeles, Los Angeles

94304

Stanford University, Palo Alto

All Listed Sponsors
collaborator

National Center for Research Resources (NCRR)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT01954056 - Hydrocortisone for Term Hypotension | Biotech Hunter | Biotech Hunter