Status:
COMPLETED
Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Adrenal Insufficiency
Eligibility:
All Genders
Up to 7 years
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- Major congenital malformations
- Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
- Postnatal corticosteroid treatment
- Refusal to give consent
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00974337
Start Date
March 1 2008
End Date
November 1 2009
Last Update
January 14 2015
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029