Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

This study has been completed.
Sponsor:
Collaborator:
BC Research Inc.
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00358748
First received: July 28, 2006
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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.

Condition Intervention Phase
Neonatal Hypotension
Drug: Hydrocortisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cumulative dose of epinephrine and total dose of fluids at 48 hours of study drug administration and by day 7 of life [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hydrocortisone
    See detailed description above.
Detailed Description:

Eligible infants will be randomly assigned to receive hydrocortisone or placebo, using sequentially numbered, preassigned treatment designations in sealed, opaque envelopes. The study drug will be randomly assigned to each patient number, in advance, using a computer-based random number generator.

Hydrocortisone and placebo doses will be prepared and provided by the hospital pharmacy following the assigned study number. Active and placebo drug solutions will be completely indistinguishable.

Infants of multiple gestations will be randomized as separate subjects. Crossover between study groups is not allowed. Physicians involved in the care of the infants will be blinded to treatment group allocation.

If the infant remains hypotensive after a Normal Saline (NS) bolus 10 ml/kg, blood for serum cortisol level determination will be drawn and hydrocortisone or an equivalent volume of NS placebo will be administered intravenously as follows: first dose immediately after randomization 2 mg/kg; 6 hours after 1 mg/kg q6h for 3 doses; followed by 0.5 mg/kg q6hs for 4 doses. If an infant responds to the initial dose of NS but becomes hypotensive within 1 hour after will also be randomized, otherwise another NS bolus could be administered.

Initiation and escalation of inotropes:

Concurrently with the first dose of study drug, dopamine infusion will be started at 5 mcg/kg/minute, increasing stepwise to a maximum of 15 mcg/kg/minute. If hypotension persists an epinephrine infusion at 0.05 mcg/kg/min will be added and increased stepwise if necessary. The aim is to maintain mean blood pressure (MBP) above the hypotensive limit defined in the inclusion criteria.

Weaning of inotropes:

Once normotension has been maintained for 1 hour or MBP > 40 mmHg for 15 minutes, weaning should be started. Dopamine infusion will be reduced first, as tolerated, to 5 mcg/kg/minute. If the subject is on epinephrine infusion the dose will be reduced stepwise to 0.05 mcg/kg/minute and discontinued. When the subject is off epinephrine and/or dopamine at 5 mcg/kg/minute, dopamine will be discontinued. If at any time hypotension recurs, weaning should be held and increased inotropes dose as per escalation algorithm.

  Eligibility

Ages Eligible for Study:   up to 30 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358748

Locations
Canada, British Columbia
Division of Neonatology, Children's and Women's Health Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
BC Research Inc.
Investigators
Principal Investigator: Horacio Osiovich, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Horacio Osiovich, University of British Columbia
ClinicalTrials.gov Identifier: NCT00358748     History of Changes
Other Study ID Numbers: C05-0006
Study First Received: July 28, 2006
Last Updated: April 11, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Preterm
hypotension
steroids
hydrocortisone

Additional relevant MeSH terms:
Birth Weight
Hypotension
Body Weight
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Antihypertensive Agents
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 29, 2014