MedTrace Logo

Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

NCT00358748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-04-12

No results posted yet for this study

Summary

The purpose of this study is to investigate the early use of hydrocortisone in hypotensive very low birth weight infants.

Based on the observations that:

* hypotension is a common problem in very low birthweight infants and is associated with brain injury and poor neurological outcomes;
* some infants are refractory to standard treatment (volume expansion and vasopressors), which is not exempt of adverse effects;
* relative adrenal insufficiency has been described in this population; we hypothesize that hydrocortisone is effective in the treatment of hypotension in this population and reduce the need for vasopressors.

Conditions

  • Neonatal Hypotension

Interventions

DRUG

Hydrocortisone

See detailed description above.

Sponsors & Collaborators

  • BC Research Inc.

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Horacio Osiovich, MD · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00358748 on ClinicalTrials.gov