Adrenal InsufficiencyNCT00974337
Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock
An observational study of Adrenal Insufficiency, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 39 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2008to Nov 2009
- Phase
- Observational
- 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 Up to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS
Who may be able to join
- All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following criteria would be enrolled.
- Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min)
- Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age.
Who cannot join
- Major congenital malformations
- Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
- Postnatal corticosteroid treatment
- Refusal to give consent
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study
The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.
Read the detailed description
Till date, no studies are available that have evaluated the incidence of relative adrenal insufficiency in preterm very low birth weight (VLBW) infants with shock. The focus had been on stable preterm and critically ill preterm infants. Given that steroid treatment improves blood pressure and stabilizes cardiovascular status in preterm infants with volume and pressor-resistant hypotension,it becomes essential to examine the incidence of adrenal insufficiency in this cohort (rather than a broad group of critically ill preterm infants). Moreover, there are no studies on adrenal function in Indian neonates.
The purpose of this study is to compare the levels of basal and stimulated (using low dose [1µg/k] ACTH) cortisol levels in preterm (28-34 weeks gestation) very low birth weight (birth weight 750 gm to 1500 gm) infants with shock in the first week of life requiring vasopressor therapy and matched (gestation, birth weight, postnatal age-matched) hemodynamically stable infants ('control group').
- Conditions
- Adrenal Insufficiency
- Keywords
- Adrenal insufficiency, cortisol, preterm, shock, neonate
- Medical subject headings
- Adrenal Insufficiency, Premature Birth, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shock | Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following: 1. Prolonged capillary refill time (>3sec) 2. Reduced urine output (<1 mL/kg/hr) 3. Metabolic acidosis (Base deficit >5) | |
| No shock | Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline cortisol
Measured: At enrollment
Stimulated cortisol (after ACTH stimulation)
Measured: 30 minutes after ACTH stimulation
Secondary outcomes (3)
Survival till discharge or day 28 of life
Measured: Until discharge or 28 days of life
Chronic lung disease (CLD)
Measured: 36 weeks postmenstrual age
Sepsis
Measured: until 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Jeeva Sankar, All India Institute of Medical Sciences
- Investigators
- Vinod K Paul, MD PhD, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiSuman Sarkar, MBBS, Principal investigator, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiMari J Sankar, MD DM, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiRamesh Agarwal, MD DM, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974337
- Sponsor's protocol ID
- A-123/2008
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2009
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT00974337
- Acronym / sponsor ID
- A-123/2008
- Conditions
- Adrenal Insufficiency
- Keywords
- Adrenal insufficiency, cortisol, preterm, shock, neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Sep 2009 (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 objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.
Detailed description
Till date, no studies are available that have evaluated the incidence of relative adrenal insufficiency in preterm very low birth weight (VLBW) infants with shock. The focus had been on stable preterm and critically ill preterm infants. Given that steroid treatment improves blood pressure and stabilizes cardiovascular status in preterm infants with volume and pressor-resistant hypotension,it becomes essential to examine the incidence of adrenal insufficiency in this cohort (rather than a broad group of critically ill preterm infants). Moreover, there are no studies on adrenal function in Indian neonates.
The purpose of this study is to compare the levels of basal and stimulated (using low dose [1µg/k] ACTH) cortisol levels in preterm (28-34 weeks gestation) very low birth weight (birth weight 750 gm to 1500 gm) infants with shock in the first week of life requiring vasopressor therapy and matched (gestation, birth weight, postnatal age-matched) hemodynamically stable infants ('control group').
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock | – | –Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following: 1. Prolonged capillary refill time (>3sec) 2. Reduced urine output (<1 mL/kg/hr) 3. Metabolic acidosis (Base deficit >5) |
| No shock | – | –Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS
Key inclusion criteria (3 listed)
- All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following criteria would be enrolled.
- Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min)
- Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age.
Key exclusion criteria (4 listed)
- Major congenital malformations
- Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
- Postnatal corticosteroid treatment
- Refusal to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline cortisol
Time frame: At enrollment
Stimulated cortisol (after ACTH stimulation)
Time frame: 30 minutes after ACTH stimulation
3 secondary outcomes
Survival till discharge or day 28 of life
Time frame: Until discharge or 28 days of life
Chronic lung disease (CLD)
Time frame: 36 weeks postmenstrual age
Sepsis
Time frame: until 28 days of life
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 14 Jan 2015.
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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.
Vinod K Paul, MD PhD study chair
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Suman Sarkar, MBBS principal investigator
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Mari J Sankar, MD DM study chair
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by All India Institute of Medical Sciences at 1 site in India.
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 3 inclusion and 4 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 14 Jan 2015. 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 India. 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.
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?
Baseline cortisol (time frame: At enrollment). The study lists 2 primary outcomes in all. 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 14 Jan 2015.