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
研究概览
地位
条件
详细说明
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').
研究类型
注册 (实际的)
联系人和位置
学习地点
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Delhi
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New Delhi、Delhi、印度、110029
- All India Institute of Medical Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Shock
Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following:
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No shock
Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Baseline cortisol
大体时间：At enrollment
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At enrollment
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Stimulated cortisol (after ACTH stimulation)
大体时间：30 minutes after ACTH stimulation
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30 minutes after ACTH stimulation
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Survival till discharge or day 28 of life
大体时间：Until discharge or 28 days of life
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Until discharge or 28 days of life
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Chronic lung disease (CLD)
大体时间：36 weeks postmenstrual age
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36 weeks postmenstrual age
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Sepsis
大体时间：until 28 days of life
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until 28 days of life
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合作者和调查者
调查人员
- 学习椅：Vinod K Paul, MD PhD、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 首席研究员：Suman Sarkar, MBBS、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 学习椅：Mari J Sankar, MD DM、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 学习椅：Ramesh Agarwal, MD DM、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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