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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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').
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Delhi
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New Delhi, Delhi, Inde, 110029
- All India Institute of Medical Sciences
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Baseline cortisol
Délai: At enrollment
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At enrollment
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Stimulated cortisol (after ACTH stimulation)
Délai: 30 minutes after ACTH stimulation
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30 minutes after ACTH stimulation
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Survival till discharge or day 28 of life
Délai: 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)
Délai: 36 weeks postmenstrual age
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36 weeks postmenstrual age
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Sepsis
Délai: until 28 days of life
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until 28 days of life
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Vinod K Paul, MD PhD, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- Chercheur principal: Suman Sarkar, MBBS, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- Chaise d'étude: Mari J Sankar, MD DM, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
- Chaise d'étude: Ramesh Agarwal, MD DM, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A-123/2008
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