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
調査の概要
状態
条件
詳細な説明
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').
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Delhi
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New Delhi、Delhi、インド、110029
- All India Institute of Medical Sciences
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Baseline cortisol
時間枠：At enrollment
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At enrollment
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Stimulated cortisol (after ACTH stimulation)
時間枠：30 minutes after ACTH stimulation
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30 minutes after ACTH stimulation
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Survival till discharge or day 28 of life
時間枠：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)
時間枠：36 weeks postmenstrual age
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36 weeks postmenstrual age
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Sepsis
時間枠：until 28 days of life
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until 28 days of life
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協力者と研究者
捜査官
- スタディチェア：Vinod K Paul, MD PhD、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- 主任研究者：Suman Sarkar, MBBS、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- スタディチェア：Mari J Sankar, MD DM、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- スタディチェア：Ramesh Agarwal, MD DM、Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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