Neonatal HypotensionPhase 3NCT00358748
Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
A Phase 3 study testing Hydrocortisone in people with Neonatal Hypotension, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 48 hours to 30 weeks
- Conditions the study is for
- Neonatal Hypotension
- What is being tested?
- Hydrocortisone
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 hours to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Clear evidence of hypovolemia (blood loss);
- Chromosomal abnormalities;
- Hydrops fetalis;
- Major congenital anomalies;
- Cardiac lesions other than patent ductus arteriosus.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Division of Neonatology, Children's and Women's Health Centre
Vancouver, British Columbia
About this study
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.
Read the 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.
- Conditions
- Neonatal Hypotension
- Being tested
- Hydrocortisone
- Keywords
- Preterm, hypotension, steroids, hydrocortisone
- Medical subject headings
- Premature Birth, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
See detailed description above.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypotensionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Research Inc.
- Investigators
- Horacio Osiovich, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358748
- Sponsor's protocol ID
- C05-0006
- Status last verified
- Apr 2011
- First submitted
- 28 Jul 2006
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT00358748
- Acronym / sponsor ID
- C05-0006
- Conditions
- Neonatal Hypotension
- Keywords
- Preterm, hypotension, steroids, hydrocortisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Research Inc.
- Study start
- Jul 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 48 hours to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Clear evidence of hypovolemia (blood loss);
- Chromosomal abnormalities;
- Hydrops fetalis;
- Major congenital anomalies;
- Cardiac lesions other than patent ductus arteriosus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneSee detailed description above. | Drug | – |
Primary outcome
Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life
Time frame: 7 days
1 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
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horacio Osiovich, MD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone in people with Neonatal Hypotension, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011.