Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock

Completed

• Conditions: Adrenal Insufficiency

• Registration Number: NCT00974337
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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 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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline cortisol	At enrollment
Stimulated cortisol (after ACTH stimulation)	30 minutes after ACTH stimulation

Secondary Outcome Measures

Name	Time	Method
Survival till discharge or day 28 of life	Until discharge or 28 days of life
Chronic lung disease (CLD)	36 weeks postmenstrual age
Sepsis	until 28 days of life

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India