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

Study Overview
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Brief Summary
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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
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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').

Official Title
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Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study

Conditions
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Adrenal Insufficiency

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shock<br>Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following: Prolonged capillary refill time (>3sec) Reduced urine output (<1 mL/kg/hr) Metabolic acidosis (Base deficit >5) | |
| No shock<br>Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline cortisol |  | At enrollment | 
| Stimulated cortisol (after ACTH stimulation) |  | 30 minutes after ACTH stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenal insufficiency, cortisol, preterm, shock, neonate