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

NCT00974337 | Completed

• 1 other identifier: A-123/2008
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Insufficiency

Keywords

Adrenal insufficiency; cortisol; preterm; shock; neonate

Outcome Measures

Primary Outcomes (2)

• Baseline cortisol

  At enrollment

• Stimulated cortisol (after ACTH stimulation)

  30 minutes after ACTH stimulation

Secondary Outcomes (3)

• 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

Study Arms (2)

Shock

Preterm VLBW infants with shock (BP \<3rd centile for gestation and birth weight with at least one of the following: 1. Prolonged capillary refill time (\>3sec) 2. Reduced urine output (\<1 mL/kg/hr) 3. Metabolic acidosis (Base deficit \>5)

No shock

Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Major congenital malformations
• Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
• Postnatal corticosteroid treatment
• Refusal to give consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Adrenal Insufficiency; Premature Birth; Shock

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vinod K Paul, MD PhD

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  STUDY CHAIR

• Suman Sarkar, MBBS

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: March 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

IN (1)