ADMA and Mechanical Ventilation in Preterm Infants | NCT00460044

Studies
ADMA and Mechanical Ventilation in Preterm Infants

NCT00460044

Sponsor

Amsterdam UMC, location VUmc

Status

Completed

Last Update Posted

Apr 13, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Premature Birth

Interventions

Not provided

Countries

Not provided

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

Apr 2007

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

Jan 2002

Primary Completion Date

Not provided

Completion Date

Jul 2003Actual

First Submitted Date

Apr 11, 2007

First Submission Date that Met QC Criteria

Apr 12, 2007

First Posted Date

Apr 13, 2007Estimated

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

Apr 12, 2007

Last Update Posted Date

Apr 13, 2007Estimated

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 purpose of this study is to study the relation between mechanical ventilation and ADMA concentrations at birth.

Detailed Description

Nitric oxide (NO) plays an important role in the normal development and maturation of the lungs. In addition, NO is an important mediator of vascular smooth muscle relaxation, ventilation perfusion matching, neurotransmission and host defence and bacteriostasis. Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS and thereby the bioavailability of NO. Preterm infants have increased concentrations of ADMA. Therefore, inhibition of NO by increased concentrations of ADMA which could be associated with reduced pulmonary functioning.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age < 32 weeks
Birth weight < 1500 gram
Written informed consent of parents

Exclusion Criteria:

Congenital abnormalities
Chromosomal abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
R M van Elburg, MD, PhD	Amsterdam UMC, location VUmc	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided