Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: BC Research Inc.
• Treatments: Antihypertensive Agents; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Clear evidence of hypovolemia (blood loss);

• Chromosomal abnormalities;

• Hydrops fetalis;

• Major congenital anomalies;

• Cardiac lesions other than patent ductus arteriosus.