Neonatal Respiratory DistressNT-proBNPNCT02020993
Urine NT-ProBNP in Neonatal Respiratory Distress
An observational study of Neonatal Respiratory Distress, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Distress
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns with first postnatal 2 days with or without respiratory distress
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University
Ankara, Ankara, 06300
Duran Yildiz, MD, +903125957459, doktorduranyildiz@hotmail.com
Duran Yildiz, MD
About this study
Official title: The Prognostic Value of Urine NT-ProBNP in Neonatal Respiratory Distress
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.
Read the 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.
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Nt-proBNP, newborn, preterm
- Medical subject headings
- Pulmonary Atelectasis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duran Yildiz, Ankara University
- Investigators
- Begüm Atasay, Professor, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020993
- Sponsor's protocol ID
- NT-proBNP Trial
- Acronym
- NT-proBNP
- Status last verified
- Jan 2014
- First submitted
- 3 Dec 2013
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Urine NT-ProBNP in Neonatal Respiratory Distress
- ClinicalTrials.gov ID
- NCT02020993
- Acronym / sponsor ID
- NT-proBNP / NT-proBNP Trial
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Nt-proBNP, newborn, preterm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns with first postnatal 2 days with or without respiratory distress
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Begüm Atasay, Professor principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Distress, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duran Yildiz, MD (+903125957459, doktorduranyildiz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of respiratory distress (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.