Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

NCT00358748 | Completed Phase 3

• 1 other identifier: C05-0006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm; hypotension; steroids; hydrocortisone

Outcome Measures

Primary Outcomes (1)

• Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life

  7 days

Secondary Outcomes (1)

• Total cumulative dose of epinephrine and total dose of fluids at 48 hours of study drug administration and by day 7 of life

  7 days

Interventions

Hydrocortisone DRUG

See detailed description above.

Eligibility Criteria

• Age: 48 Hours - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≤ 30 weeks, Birth weight ≤ 1250 grams and ≤ 48 hours age;
• Umbilical or peripheral arterial catheter in place;
• Invasive mean blood pressure \< gestational age in completed weeks after 1 Normal Saline bolus 10 ml/kg;
• Parental/legal guardian consent.

You may not qualify if:

• Clear evidence of hypovolemia (blood loss);
• Chromosomal abnormalities;
• Hydrops fetalis;
• Major congenital anomalies;
• Cardiac lesions other than patent ductus arteriosus.

Sponsors & Collaborators

• University of British Columbia: lead
• BC Research Inc.: collaborator

Study Sites (1)

Division of Neonatology, Children's and Women's Health Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Premature Birth; Hypotension

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Horacio Osiovich, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: July 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 12, 2011

Record last verified: 2011-04

Locations

CA (1)