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New treatment option for Congenital Heart Disease in Children
Official title Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
ClinicalTrials.gov ID: NCT04217421
What this study is testing
What is Allopurinol?
Allopurinol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for congenital heart disease in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 1
You may be able to join if
- Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of...
- Informed consent provided by both parents.
You likely can't join if
- Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis.
- Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.
- Gestational age below 36 weeks and/or birth weight less than 2000 gram.
- Surgery not requiring cardiopulmonary bypass.
- Decision for "comfort care only".
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 1 month. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands; Nijmegen, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.