Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock
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Purpose
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.
| Condition |
|---|
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Adrenal Insufficiency |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study |
- Baseline cortisol [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
- Stimulated cortisol (after ACTH stimulation) [ Time Frame: 30 minutes after ACTH stimulation ] [ Designated as safety issue: No ]
- Survival till discharge or day 28 of life [ Time Frame: Until discharge or 28 days of life ] [ Designated as safety issue: No ]
- Chronic lung disease (CLD) [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: No ]
- Sepsis [ Time Frame: until 28 days of life ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Shock
Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following:
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No shock
Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output
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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').
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Major congenital malformations
- Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
- Postnatal corticosteroid treatment
- Refusal to give consent
Contacts and Locations| Contact: Vinod K Paul, MD PhD | 91-11-26593209 | vinodkpaul@hotmail.com |
| Contact: Ramesh Agarwal, MD DM | 91-11-26593621 | aranag@rediffmail.com |
| India | |
| All India Institute of Medical Sciences | Recruiting |
| New Delhi, Delhi, India, 110029 | |
| Study Chair: | Vinod K Paul, MD PhD | Department of Pediatrics, All India Institute of Medical Sciences, New Delhi |
| Principal Investigator: | Suman Sarkar, MBBS | Department of Pediatrics, All India Institute of Medical Sciences, New Delhi |
| Study Chair: | Mari J Sankar, MD DM | Department of Pediatrics, All India Institute of Medical Sciences, New Delhi |
| Study Chair: | Ramesh Agarwal, MD DM | Department of Pediatrics, All India Institute of Medical Sciences, New Delhi |
More Information
No publications provided
| Responsible Party: | Suman Sarkar, Department of Pediatrics, AIIMS, New Delhi |
| ClinicalTrials.gov Identifier: | NCT00974337 History of Changes |
| Other Study ID Numbers: | A-123/2008 |
| Study First Received: | September 9, 2009 |
| Last Updated: | September 9, 2009 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
Adrenal insufficiency cortisol preterm shock neonate |
Additional relevant MeSH terms:
|
Addison Disease Adrenal Insufficiency Birth Weight Shock Adrenal Gland Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Body Weight Signs and Symptoms Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013