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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

Tracking Information
First Submitted Date December 3, 2013
First Posted Date December 27, 2013
Last Update Posted Date January 6, 2014
Study Start Date December 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2013)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Urine NT-ProBNP in Neonatal Respiratory Distress
Official Title The Prognostic Value of Urine NT-ProBNP in Neonatal Respiratory Distress
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine NT-proBNP
Sampling Method Non-Probability Sample
Study Population Newborns with first postnatal 2 days with or without respiratory distress
Condition Neonatal Respiratory Distress
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 19, 2013)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 7 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT02020993
Other Study ID Numbers NT-proBNP Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duran Yildiz, Ankara University
Study Sponsor Ankara University
Collaborators Not Provided
Investigators
Principal Investigator: Begüm Atasay, Professor Ankara University
PRS Account Ankara University
Verification Date January 2014