UnknownPhase 3

Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

Canada50 participantsStarted 2010-03

Plain-language summary

The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood strategy.

Who can participate

Age range

3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of functional single ventricle anatomy amenable to Norwood or Hybrid first stage palliation.
. Informed consent of parent(s) or legal guardian.

Exclusion criteria

. Pre-operative identification of anatomy rendering either a Norwood or Hybrid procedure clinically inappropriate;
. Recent history of significant cerebral bleed or necrotizing enterocolitis;
. Severe hemodynamic instability;
. Any other major congenital abnormality (i.e. congenital diaphragmatic hernia, tracheoesophageal fistula) or clinically significant acquired extra-cardiac disorder (e.g. meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurologic and functional outcomes

Timeframe: 14 months of age

Neurologic and functional outcomes

Timeframe: 3 years of age (during procedure 3 pre-op)

Trial details

NCT IDNCT01134302

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

Contact for this trial

Christopher Caldarone

416-813-6420 christopher.caldarone@sickkids.ca

View on ClinicalTrials.gov More Congenital Heart Disease trials