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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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').


Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome:

  • Baseline cortisol [ Time Frame: At enrollment ]
  • Stimulated cortisol (after ACTH stimulation) [ Time Frame: 30 minutes after ACTH stimulation ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival till discharge or day 28 of life [ Time Frame: Until discharge or 28 days of life ]
  • Chronic lung disease (CLD) [ Time Frame: 36 weeks postmenstrual age ]
  • Sepsis [ Time Frame: until 28 days of life ]


Original Secondary Outcome: Same as current

Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: September 9, 2009
Date Started: March 2008
Date Completion:
Last Updated: January 13, 2015
Last Verified: January 2015