Relative Adrenal Insufficiency in Preterm Very Low Birth... | NCT00974337

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

NCT00974337

Sponsor

All India Institute of Medical Sciences

Status

Completed

Last Update Posted

Jan 14, 2015Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Adrenal Insufficiency

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Sep 9, 2009

First Submission Date that Met QC Criteria

Sep 9, 2009

First Posted Date

Sep 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2015

Last Update Posted Date

Jan 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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').

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shock		Preterm VLBW infants with shock (BP <3rd centile for gestation and birth weight with at least one of the following: Prolonged capillary refill time (>3sec) Reduced urine output (<1 mL/kg/hr) Metabolic acidosis (Base deficit >5)
No shock		Hemodynamically stable infant with normal blood pressure, capillary refill time, and urine output

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline cortisol		At enrollment
Stimulated cortisol (after ACTH stimulation)		30 minutes after ACTH stimulation

Secondary Outcomes

Measure	Description	Time Frame
Survival till discharge or day 28 of life		Until discharge or 28 days of life
Chronic lung disease (CLD)		36 weeks postmenstrual age
Sepsis

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vinod K Paul, MD PhD	Department of Pediatrics, All India Institute of Medical Sciences, New Delhi	Study Chair
Suman Sarkar, MBBS	Department of Pediatrics, All India Institute of Medical Sciences, New Delhi	Principal Investigator
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	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
All India Institute of Medical Sciences		New Delhi	National Capital Territory of Delhi	110029	India

Condition Browse Module

MeSH Terms

ID	Term
D000309	Adrenal Insufficiency
D047928	Premature Birth
D012769	Shock

Ancestor Terms

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications

Browse Leaves

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Browse Branches

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