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 range3 Months

SexALL

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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).

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

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