PDANCT02396004
NIRS in PDA VLBW Infants
An observational study of PDA, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Aim of study: To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- PDA
- What is being tested?
- Near Infrared Red Spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2014to Dec 2016
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical
Who may be able to join
- VLBW infants with hemodynamically significant PDA by echocardiography
Who cannot join
- Major malformation
- Moribund
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants
Aim of study:
To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.
Study population/inclusion criteria:
VLBW newborn babies with hemodynamically significant PDA by echocardiography.
Exclusion criteria:
Major malformations Moribund patients
Read the detailed description
Aim of study:
To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.
Study population/inclusion criteria:
VLBW newborn babies with hemodynamically significant PDA by echocardiography.
Exclusion criteria:
Major malformations Moribund patients
Protocol:
Consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter
The same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.
- Conditions
- PDA
- Being tested
- Near Infrared Red Spectroscopy (NIRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Red Spectroscopy (NIRS)Device
NIRS using INVOS cerebral/somatic oximeter
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oximetry
Measured: 2 years
Secondary outcomes (1)
renal oximetry
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Woei Bing Poon, MRCPCH, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396004
- Sponsor's protocol ID
- CIRB 2013/379/E
- Status last verified
- Feb 2017
- First submitted
- 18 Mar 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants
- ClinicalTrials.gov ID
- NCT02396004
- Acronym / sponsor ID
- CIRB 2013/379/E
- Conditions
- PDA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Mar 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.
Aim of study:
To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.
Study population/inclusion criteria:
VLBW newborn babies with hemodynamically significant PDA by echocardiography.
Exclusion criteria:
Major malformations Moribund patients
Detailed description
Aim of study:
To conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.
Study population/inclusion criteria:
VLBW newborn babies with hemodynamically significant PDA by echocardiography.
Exclusion criteria:
Major malformations Moribund patients
Protocol:
Consent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter
The same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical
Key inclusion criteria (1 listed)
- VLBW infants with hemodynamically significant PDA by echocardiography
Key exclusion criteria (2 listed)
- Major malformation
- Moribund
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 |
|---|---|---|
| Near Infrared Red Spectroscopy (NIRS)NIRS using INVOS cerebral/somatic oximeter | Device | – |
Primary outcome
cerebral oximetry
Time frame: 2 years
1 secondary outcome
renal oximetry
Time frame: 2 years
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 10 Feb 2017.
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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.
Woei Bing Poon, MRCPCH principal investigator
Singapore General Hospital
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 PDA, run by Singapore General Hospital at 1 site in Singapore.
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 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 10 Feb 2017. 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 Singapore. 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?
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?
cerebral oximetry (time frame: 2 years). 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 10 Feb 2017.