Urine NT-ProBNP in Neonatal Respiratory Distress

NCT ID: NCT02020993

Last Updated: 2014-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Neonatal Respiratory Distress

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Duran Yildiz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Begüm Atasay, Professor

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Ankara University

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Duran Yildiz, MD

Role: CONTACT

+903125957459

Facility Contacts

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Duran Yildiz, MD

Role: primary

+903125957459

Other Identifiers

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NT-proBNP Trial

Identifier Type: -

Identifier Source: org_study_id

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