An observational study in PDA, sponsored by Singapore General Hospital. Completed at 1 site in Singapore. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Singapore General Hospital · Observational
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
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.
Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical
Exclusion Criteria:
NIRS using INVOS cerebral/somatic oximeter
cerebral oximetry
Time frame: 2 years
renal oximetry
Time frame: 2 years
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Singapore General Hospital