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Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M. Jeeva Sankar, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00974337
First received: September 9, 2009
Last updated: January 13, 2015
Last verified: January 2015

September 9, 2009
January 13, 2015
March 2008
November 2009   (final data collection date for primary outcome measure)
  • Baseline cortisol [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
  • Stimulated cortisol (after ACTH stimulation) [ Time Frame: 30 minutes after ACTH stimulation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974337 on ClinicalTrials.gov Archive Site
  • Survival till discharge or day 28 of life [ Time Frame: Until discharge or 28 days of life ] [ Designated as safety issue: No ]
  • Chronic lung disease (CLD) [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: No ]
  • Sepsis [ Time Frame: until 28 days of life ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

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').

Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS
Adrenal Insufficiency
Not Provided
  • Shock

    Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following:

    1. Prolonged capillary refill time (>3sec)
    2. Reduced urine output (<1 mL/kg/hr)
    3. Metabolic acidosis (Base deficit >5)
  • No shock
    Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
up to 7 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00974337
A-123/2008
No
Not Provided
Not Provided
M. Jeeva Sankar, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
Not Provided
Study Chair: Vinod K Paul, MD PhD Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Principal Investigator: Suman Sarkar, MBBS Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Study Chair: Mari J Sankar, MD DM Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Study Chair: Ramesh Agarwal, MD DM Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP