Clinical trial NCT00974337: Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock
Official title: Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Keywords: Adrenal insufficiency
cortisol
preterm
shock
neonate
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 39
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS

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').

Eligibility criteria: 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

Primary outcomes:
measure: Baseline cortisol
timeFrame: At enrollment
measure: Stimulated cortisol (after ACTH stimulation)
timeFrame: 30 minutes after ACTH stimulation
Secondary outcomes:
measure: Survival till discharge or day 28 of life
timeFrame: Until discharge or 28 days of life
measure: Chronic lung disease (CLD)
timeFrame: 36 weeks postmenstrual age
measure: Sepsis
timeFrame: until 28 days of life
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Vinod K Paul, MD PhD
role: STUDY_CHAIR
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Suman Sarkar, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Mari J Sankar, MD DM
role: STUDY_CHAIR
affiliation: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
name: Ramesh Agarwal, MD DM
role: STUDY_CHAIR
References: