We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00974337
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Adrenal Insufficiency

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').


Study Design

Study Type : Observational
Actual Enrollment : 39 participants
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
Study Start Date : March 2008
Primary Completion Date : November 2009
Study Completion Date : November 2009


Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Baseline cortisol [ Time Frame: At enrollment ]
  2. Stimulated cortisol (after ACTH stimulation) [ Time Frame: 30 minutes after ACTH stimulation ]

Secondary Outcome Measures :
  1. Survival till discharge or day 28 of life [ Time Frame: Until discharge or 28 days of life ]
  2. Chronic lung disease (CLD) [ Time Frame: 36 weeks postmenstrual age ]
  3. Sepsis [ Time Frame: until 28 days of life ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974337


Locations
India
All India Institute of Medical Sciences
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

Responsible Party: M. Jeeva Sankar, Assistant Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00974337     History of Changes
Other Study ID Numbers: A-123/2008
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Birth Weight
Adrenal Insufficiency
Body Weight
Signs and Symptoms
Adrenal Gland Diseases
Endocrine System Diseases