Plasma N-terminal proBNP Concentrations and Patent Ductus... | NCT00725647

Studies
Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies

NCT00725647

Sponsor

St George's, University of London

Status

Completed

Last Update Posted

Sep 18, 2009Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Ductus Arteriosus, Patent

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

Sep 2009

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

May 2005

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 29, 2008

First Posted Date

Jul 30, 2008Estimated

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

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

St George's, University of LondonOTHER

Collaborators

Name	Class
National Health Service, United Kingdom	OTHER_GOV
Medical Research Council	OTHER_GOV

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

Premature babies are affected by a condition known as "patent ductus arteriosus" in which the ductus arteriosus (a normal structure) fails to close after birth as it should. A very large ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on a mechanical ventilator. Attending physicians can close the duct with medical\or surgical treatment but assessing whether this is justified can be difficult. The physician usually bases this decision on assessment of the baby's general condition and an ultrasound evaluation of the heart (called an "echocardiogram") but the last is particularly dependent on availability of skilled operators.

The investigators have examined whether blood levels of a hormone called B-type natriuretic peptide (Nt pro-BNP)in the first week of life predict the need to treat a ductus arteriosus. This hormone is produced by the heart if it is under strain. If the test is helpful it could reduce dependence of physicians on echocardiography by skilled operators.

Babies who were recruited had blood samples collected on days 1, 2, 3 and 7 for measurement of Nt pro-BNP. Each baby also had an echocardiogram performed between the fifth and seventh day of life. Decisions about treatment of the duct were made by attending physicians independent of the study. Physicians, investigators and echocardiographers were blinded to knowledge of the Nt pro-BNP concentration. Nt pro-BNP was also measured before and after treatment in all babies who had a PDA treated and echocardiography performed to confirm closure.

Receiver operating characteristics (ROC) curves were used to assess the predictive value of Nt pro-BNP for samples collected at each time point. The investigators also compared the Nt pro-BNP levels in samples collected before and after treatment to assess the usefulness of Nt pr-BNP as an indicator of duct closure.

Detailed Description

Not provided

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

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated PDA		Infants who had a PDA which the attending physicians treated medically or surgically.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm babies under 34-weeks gestation admitted to the neonatal intensive care unit

Exclusion Criteria:

Known structural heart abnormality other than PDA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Preterm infants in a tertiary level neonatal intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Santhanakrishnan Ramakrishnan, MB MRCPCH	St George's Healthcare NHS Trust	Principal Investigator
Anthony F Williams, MB FRCPCH	St George's, University of London	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19432837	Result	Ramakrishnan S, Heung YM, Round J, Morris TP, Collinson P, Williams AF. Early N-terminal pro-brain natriuretic peptide measurements predict clinically significant ductus arteriosus in preterm infants. Acta Paediatr. 2009 Aug;98(8):1254-9. doi: 10.1111/j.1651-2227.2009.01315.x. Epub 2009 Apr 30.

ID	Term
D004374	Ductus Arteriosus, Patent
D004194	Disease
D047928	Premature Birth

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases