Reference Values of BNP in Healthy NewbornNCT02574806
Normal Values of Brain Natriuretic Peptide in Healthy Newborn
An observational study of Reference Values of BNP in Healthy Newborn, run by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud.
Trial summary
Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and diuresis. Read more about this study
- Who is it for?
- Ages Up to 1 minuteHealthy volunteers can take part
- Conditions the study is for
- Reference Values of BNP in Healthy Newborn
- What is being tested?
- Blood sample and BNP measurement
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 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 Up to 1 minute
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy term newborn obtained by vaginal delivery and/or cesarean section.
Who may be able to join
- healthy mother with pregnancy at term (38 to 42 gestational weeks) with adequate prenatal care.
- newborns with Apgar score ≥ 7 at 0 and 5 minutes respectively.
Who cannot join
- newborns of mothers with pregnancy-associated diseases.
- newborns with chromosomopathies detected during the antenatal care and newborns with signs of cardiac and/or respiratory compromise.
About this study
Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as expression of renal maturity could explain the subsequent decrease in serum values. This would suggest that, in healthy newborns, BNP values should be found within a given ranges. However, the evidence suggests an important variability in BNP values 2 - 4. In the other hand, in the newborn with respiratory distress BNP could have a high negative predictive value to rule out acute myocardial processes, as responsible for clinical deterioration, from infectious, metabolic or respiratory processes; with a potential of improvement in medical care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP normal values remain unknown in the healthy newborn. Therefore, the investigators performed a pioneer study to establish normal values in healthy newborn population. Multi-center, prospective and observational study was carried out. Objective: To establish normal BNP values in healthy newborn.
- Being tested
- Blood sample and BNP measurement
- Keywords
- BNP, Reference values, Newborn, Ventricular function, Stress, Pediatrics, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and BNP measurementProcedure or surgery
Blood sample of umbilical artery from umbilical cord immediately after birth.
| Study group | Role | What they receive |
|---|---|---|
| Healthy newborn | Healthy newborn at term of healthy mother. Receives: Procedure: Blood sample and BNP measurement | |
| Preeclamptic newborn | Newborn at term of mother with pre-eclampsia with severity features. Receives: Procedure: Blood sample and BNP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
BNP values
Measured: within the first minute after birth and data will present through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reference Values of BNP in Healthy NewbornStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574806
- Sponsor's protocol ID
- EBNPRNS01
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2015
- Last updated
- 19 Oct 2018
- Results posted
- No
Publications
Rodriguez D, Garcia-Rivas G, Laresgoiti-Servitje E, Yanez J, Torre-Amione G, Jerjes-Sanchez C. B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional study. BMJ Open. 2018 Oct 17;8(10):e022562. doi: 10.1136/bmjopen-2018-022562.
PubMed 30337314
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of Brain Natriuretic Peptide in Healthy Newborn
- ClinicalTrials.gov ID
- NCT02574806
- Acronym / sponsor ID
- EBNPRNS01
- Keywords
- BNP, Reference values, Newborn, Ventricular function, Stress, Pediatrics, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec SaludUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Oct 2015 (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.
Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as expression of renal maturity could explain the subsequent decrease in serum values. This would suggest that, in healthy newborns, BNP values should be found within a given ranges. However, the evidence suggests an important variability in BNP values 2 - 4. In the other hand, in the newborn with respiratory distress BNP could have a high negative predictive value to rule out acute myocardial processes, as responsible for clinical deterioration, from infectious, metabolic or respiratory processes; with a potential of improvement in medical care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP normal values remain unknown in the healthy newborn. Therefore, the investigators performed a pioneer study to establish normal values in healthy newborn population. Multi-center, prospective and observational study was carried out. Objective: To establish normal BNP values in healthy newborn.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy newborn | – | Procedure: Blood sample and BNP measurementHealthy newborn at term of healthy mother. |
| Preeclamptic newborn | – | Procedure: Blood sample and BNP measurementNewborn at term of mother with pre-eclampsia with severity features. |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy term newborn obtained by vaginal delivery and/or cesarean section.
Key inclusion criteria (2 listed)
- healthy mother with pregnancy at term (38 to 42 gestational weeks) with adequate prenatal care.
- newborns with Apgar score ≥ 7 at 0 and 5 minutes respectively.
Key exclusion criteria (2 listed)
- newborns of mothers with pregnancy-associated diseases.
- newborns with chromosomopathies detected during the antenatal care and newborns with signs of cardiac and/or respiratory compromise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample and BNP measurementBlood sample of umbilical artery from umbilical cord immediately after birth. | Procedure or surgery | Healthy newborn, Preeclamptic newborn |
Primary outcome
BNP values
Time frame: within the first minute after birth and data will present through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Derived from this study: PubMed 30337314Rodriguez D, Garcia-Rivas G, Laresgoiti-Servitje E, Yanez J, Torre-Amione G, Jerjes-Sanchez C. B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional study. BMJ Open. 2018 Oct 17;8(10):e022562. doi: 10.1136/bmjopen-2018-022562.
- B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional studyLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Reference Values of BNP in Healthy Newborn, run by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud.
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 2 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: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BNP values (time frame: within the first minute after birth and data will present through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574806, which also lists 1 linked publication.
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 19 Oct 2018.