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

Ankara University

Status: Unknown

Conditions: Neonatal Respiratory Distress

Study type: Observational

Funder types: Other

Identifiers

NCT02020993

NT-proBNP Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Respiratory distress group

Description:

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

Description:

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.