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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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').
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Delhi
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New Delhi, Delhi, Indië, 110029
- All India Institute of Medical Sciences
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Baseline cortisol
Tijdsspanne: At enrollment
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At enrollment
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Stimulated cortisol (after ACTH stimulation)
Tijdsspanne: 30 minutes after ACTH stimulation
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30 minutes after ACTH stimulation
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Survival till discharge or day 28 of life
Tijdsspanne: 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)
Tijdsspanne: 36 weeks postmenstrual age
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36 weeks postmenstrual age
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Sepsis
Tijdsspanne: until 28 days of life
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until 28 days of life
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Vinod K Paul, MD PhD, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- Hoofdonderzoeker: Suman Sarkar, MBBS, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- Studie stoel: Mari J Sankar, MD DM, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- Studie stoel: Ramesh Agarwal, MD DM, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A-123/2008
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