Urine NT-ProBNP in Neonatal Respiratory Distress | NCT02020993

Studies
Urine NT-ProBNP in Neonatal Respiratory Distress

NCT02020993

Sponsor

Ankara University

Status

Unknown status

Last Update Posted

Jan 6, 2014Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Neonatal Respiratory Distress

Interventions

Not provided

Countries

Turkey (Türkiye)

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Dec 3, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 27, 2013Estimated

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 3, 2014

Last Update Posted Date

Jan 6, 2014Estimated

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

There is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease.

Urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn.

The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory diseases in newborns by a controlled trial.

Detailed Description

Neonatal diseases such as respiratory distress and transient tachypnea of newborn may require high level of intensive care. On the other hand, some minor difficulties in respiration can resolve within hours. Therefore, there is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease.

Serum NT-ProBNP level has been evaluated in transient tachypnea of newborn and found compatible with the clinical progress. Urine NT-proBNP has recently been evaluated in patent ductus arterioses and found compatible with the cardiac progress. However, urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn.

The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory diseases in newborns by a controlled trial.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Respiratory distress group		Newborns with respiratory distress will constitute the study group. All patients will be evaluated by Urine NT-proBNP and echocardiography on postnatal days 1-2 and 5-7.
Control Group		Newborns without any respiratory and cardiac diseases will constitute the control group, and will be evaluated by urine Nt-proBNP and echocardiography on postnatal days 1-2 and 5-7.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
severity of respiratory distress	Severity of respiratory distress will be evaluated by requirement of supportive treatment such as continuous positive airway pressure, need of intubation, mechanical ventilation and duration of support (hours)	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

study group; newborns who are admitted to the neonatal intensive care unit within first 2 days of life and have transient tachypnea of newborn or respiratory distress syndrome signed informed consent form
Control Group: Newborns without any respiratory distress

Exclusion Criteria:

any cardiac anomaly sepsis acute renal insufficiency syndromic cases low APGAR score at 5th minute (<7) lung malformations no informed consent inability in collection of urine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Days

Standard Ages

Child

Study Population

Newborns with first postnatal 2 days with or without respiratory distress

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Duran Yildiz, MD	Contact	+903125957459		doktorduranyildiz@hotmail.com

Overall Officials

Name	Affiliation	Role
Begüm Atasay, Professor	Ankara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University	Recruiting	Ankara	Ankara	06300	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis
D047928	Premature Birth

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications

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