Urine NT-ProBNP in Neonatal Respiratory Distress

NCT02020993 | Unknown

• 1 other identifier: NT-proBNP Trial
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Respiratory Distress

Keywords

Nt-proBNP, newborn, preterm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns with first postnatal 2 days with or without respiratory distress

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Ankara, 06300, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine NT-proBNP

MeSH Terms

Conditions

Pulmonary Atelectasis; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Begüm Atasay, Professor

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duran Yildiz, MD

CONTACT

+903125957459; doktorduranyildiz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

TU (1)