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Urine NT-ProBNP in Neonatal Respiratory Distress (NT-proBNP)

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ClinicalTrials.gov Identifier: NCT02020993
Recruitment Status : Unknown
Verified January 2014 by Duran Yildiz, Ankara University.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Duran Yildiz, Ankara University

Study Description
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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.


Condition or disease
Neonatal Respiratory Distress

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Prognostic Value of Urine NT-ProBNP in Neonatal Respiratory Distress
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : January 2015

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Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. severity of respiratory distress [ Time Frame: 7 days ]
    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)


Biospecimen Retention:   Samples Without DNA
Urine NT-proBNP

Eligibility Criteria
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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newborns with first postnatal 2 days with or without respiratory distress
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020993


Contacts
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Contact: Duran Yildiz, MD +903125957459 doktorduranyildiz@hotmail.com

Locations
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Turkey
Ankara University Recruiting
Ankara, Turkey, 06300
Contact: Duran Yildiz, MD    +903125957459    doktorduranyildiz@hotmail.com   
Principal Investigator: Duran Yildiz, MD         
Sponsors and Collaborators
Ankara University
Investigators
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Principal Investigator: Begüm Atasay, Professor Ankara University
More Information
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Responsible Party: Duran Yildiz, MD, Ankara University
ClinicalTrials.gov Identifier: NCT02020993    
Other Study ID Numbers: NT-proBNP Trial
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Duran Yildiz, Ankara University:
Nt-proBNP, newborn, preterm
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases