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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00974337

Enrollment

Registered

2009-09-10

Start date

2008-03-31

Completion date

2009-11-30

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency

Keywords

Adrenal insufficiency, cortisol, preterm, shock, neonate

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').

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results