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

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Shock; 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; Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 9, 2009
• First Posted (Estimate): September 10, 2009

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: preterm; shock; cortisol; neonate; Adrenal insufficiency
• Additional Relevant MeSH Terms: Endocrine System Diseases; Body Weight; Adrenal Gland Diseases; Birth Weight; Adrenal Insufficiency
• Other Study ID Numbers: A-123/2008