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

• ClinicalTrials.gov Identifier: NCT02020993
• Recruitment Status: Unknown
• First Posted: December 27, 2013
• Last Update Posted: January 6, 2014
• Sponsor: Ankara University
• 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
• 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

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

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