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

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974337
• Other study ID #: A-123/2008
• Status: Completed
• Phase: N/A
• First received: September 9, 2009
• Last updated: January 13, 2015
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2015
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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').

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Birth Weight

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline cortisol		At enrollment	No
Primary	Stimulated cortisol (after ACTH stimulation)		30 minutes after ACTH stimulation	No
Secondary	Survival till discharge or day 28 of life		Until discharge or 28 days of life	No
Secondary	Chronic lung disease (CLD)		36 weeks postmenstrual age	No
Secondary	Sepsis		until 28 days of life	No