Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Baseline cortisol
研究概览
简要总结
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.
详细描述
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').
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Major congenital malformations
- •Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid)
- •Postnatal corticosteroid treatment
- •Refusal to give consent
结局指标
主要结局
Baseline cortisol
时间窗: At enrollment
Stimulated cortisol (after ACTH stimulation)
时间窗: 30 minutes after ACTH stimulation
次要结局
- 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)
研究者
M. Jeeva Sankar
Assistant Professor
All India Institute of Medical Sciences, New Delhi