Ductus Arteriosus, PatentNCT00725647
Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies
An observational study of Ductus Arteriosus, Patent, run by St George's, University of London.
Trial summary
Premature babies are affected by a condition known as "patent ductus arteriosus" in which the ductus arteriosus (a normal structure) fails to close after birth as it should. A very large ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on a mechanical ventilator. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ductus Arteriosus, Patent
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jun 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants in a tertiary level neonatal intensive care unit
Who may be able to join
- Preterm babies under 34-weeks gestation admitted to the neonatal intensive care unit
Who cannot join
- Known structural heart abnormality other than PDA
About this study
Official title: A Study of the Value of Plasma N-terminal proBNP Concentrations for Diagnosing Patent Ductus Arteriosus in Preterm Babies.
Premature babies are affected by a condition known as "patent ductus arteriosus" in which the ductus arteriosus (a normal structure) fails to close after birth as it should. A very large ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on a mechanical ventilator. Attending physicians can close the duct with medical\or surgical treatment but assessing whether this is justified can be difficult. The physician usually bases this decision on assessment of the baby's general condition and an ultrasound evaluation of the heart (called an "echocardiogram") but the last is particularly dependent on availability of skilled operators.
The investigators have examined whether blood levels of a hormone called B-type natriuretic peptide (Nt pro-BNP)in the first week of life predict the need to treat a ductus arteriosus. This hormone is produced by the heart if it is under strain. If the test is helpful it could reduce dependence of physicians on echocardiography by skilled operators.
Read more
Babies who were recruited had blood samples collected on days 1, 2, 3 and 7 for measurement of Nt pro-BNP. Each baby also had an echocardiogram performed between the fifth and seventh day of life. Decisions about treatment of the duct were made by attending physicians independent of the study. Physicians, investigators and echocardiographers were blinded to knowledge of the Nt pro-BNP concentration. Nt pro-BNP was also measured before and after treatment in all babies who had a PDA treated and echocardiography performed to confirm closure.
Receiver operating characteristics (ROC) curves were used to assess the predictive value of Nt pro-BNP for samples collected at each time point. The investigators also compared the Nt pro-BNP levels in samples collected before and after treatment to assess the usefulness of Nt pr-BNP as an indicator of duct closure.
- Conditions
- Ductus Arteriosus, Patent
- Keywords
- N terminal B type natriuretic peptide, echocardiography, diagnosis, atrial natriuretic peptides, preterm infant
- Medical subject headings
- Ductus Arteriosus, Patent, Disease, 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 |
|---|---|---|
| Treated PDA | Infants who had a PDA which the attending physicians treated medically or surgically. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startMay 2005
- Primary completionJun 2007
- Study completionJun 2007
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 Ductus Arteriosus, PatentStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom, Medical Research Council
- Investigators
- Santhanakrishnan Ramakrishnan, MB MRCPCH, Principal investigator, St George's Healthcare NHS TrustAnthony F Williams, MB FRCPCH, Study director, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725647
- Sponsor's protocol ID
- 04/Q0803/98
- Status last verified
- Sep 2009
- First submitted
- 28 Jul 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramakrishnan S, Heung YM, Round J, Morris TP, Collinson P, Williams AF. Early N-terminal pro-brain natriuretic peptide measurements predict clinically significant ductus arteriosus in preterm infants. Acta Paediatr. 2009 Aug;98(8):1254-9. doi: 10.1111/j.1651-2227.2009.01315.x. Epub 2009 Apr 30.
PubMed 19432837
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Value of Plasma N-terminal proBNP Concentrations for Diagnosing Patent Ductus Arteriosus in Preterm Babies.
- ClinicalTrials.gov ID
- NCT00725647
- Acronym / sponsor ID
- 04/Q0803/98
- Conditions
- Ductus Arteriosus, Patent
- Keywords
- N terminal B type natriuretic peptide, echocardiography, diagnosis, atrial natriuretic peptides, preterm infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom, Medical Research Council
- Study start
- May 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 30 Jul 2008 (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.
Premature babies are affected by a condition known as "patent ductus arteriosus" in which the ductus arteriosus (a normal structure) fails to close after birth as it should. A very large ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on a mechanical ventilator. Attending physicians can close the duct with medical\or surgical treatment but assessing whether this is justified can be difficult. The physician usually bases this decision on assessment of the baby's general condition and an ultrasound evaluation of the heart (called an "echocardiogram") but the last is particularly dependent on availability of skilled operators.
The investigators have examined whether blood levels of a hormone called B-type natriuretic peptide (Nt pro-BNP)in the first week of life predict the need to treat a ductus arteriosus. This hormone is produced by the heart if it is under strain. If the test is helpful it could reduce dependence of physicians on echocardiography by skilled operators.
Babies who were recruited had blood samples collected on days 1, 2, 3 and 7 for measurement of Nt pro-BNP. Each baby also had an echocardiogram performed between the fifth and seventh day of life. Decisions about treatment of the duct were made by attending physicians independent of the study. Physicians, investigators and echocardiographers were blinded to knowledge of the Nt pro-BNP concentration. Nt pro-BNP was also measured before and after treatment in all babies who had a PDA treated and echocardiography performed to confirm closure.
Receiver operating characteristics (ROC) curves were used to assess the predictive value of Nt pro-BNP for samples collected at each time point. The investigators also compared the Nt pro-BNP levels in samples collected before and after treatment to assess the usefulness of Nt pr-BNP as an indicator of duct closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated PDA | – | –Infants who had a PDA which the attending physicians treated medically or surgically. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants in a tertiary level neonatal intensive care unit
Key inclusion criteria (1 listed)
- Preterm babies under 34-weeks gestation admitted to the neonatal intensive care unit
Key exclusion criteria (1 listed)
- Known structural heart abnormality other than PDA
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
Not reported in the source record.
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 18 Sep 2009.
- Results publication: PubMed 19432837Ramakrishnan S, Heung YM, Round J, Morris TP, Collinson P, Williams AF. Early N-terminal pro-brain natriuretic peptide measurements predict clinically significant ductus arteriosus in preterm infants. Acta Paediatr. 2009 Aug;98(8):1254-9. doi: 10.1111/j.1651-2227.2009.01315.x. Epub 2009 Apr 30.
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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.
Santhanakrishnan Ramakrishnan, MB MRCPCH principal investigator
St George's Healthcare NHS Trust
Anthony F Williams, MB FRCPCH study director
St George's, University of London
Questions about this trial
What is this clinical trial studying?
An observational study of Ductus Arteriosus, Patent, run by St George's, University of London.
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 1 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: finished, as of the sponsor's last update on 18 Sep 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00725647, 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 18 Sep 2009.