Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Hypotension
Intervention: Hydrocortisone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Horacio Osiovich, MD, Principal Investigator, Affiliation: The University of British Columbia
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.
Clinical Details
Official title: Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life
Secondary outcome: Total cumulative dose of epinephrine and total dose of fluids at 48 hours of study drug administration and by day 7 of life
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
Minimum age: N/A.
Maximum age: 30 Weeks.
Gender(s): Both.
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.
Locations and Contacts
Division of Neonatology, Children's and Women's Health Centre, Vancouver, British Columbia, Canada
Additional Information
Starting date: July 2005
Last updated: April 11, 2011
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