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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00974337
First received: September 9, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition
Adrenal Insufficiency

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Basal and Stimulated Cortisol Levels in Preterm Very Low Birth Weight Infants With and Without Shock: A Cross-sectional Study

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: March 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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').

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams) infants born at AIIMS

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974337

Contacts
Contact: Vinod K Paul, MD PhD 91-11-26593209 vinodkpaul@hotmail.com
Contact: Ramesh Agarwal, MD DM 91-11-26593621 aranag@rediffmail.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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
  More Information

No publications provided

Responsible Party: Suman Sarkar, Department of Pediatrics, AIIMS, New Delhi
ClinicalTrials.gov Identifier: NCT00974337     History of Changes
Other Study ID Numbers: A-123/2008
Study First Received: September 9, 2009
Last Updated: September 9, 2009
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Adrenal insufficiency
cortisol
preterm
shock
neonate

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Birth Weight
Shock
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Body Weight
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014