NCT01134302

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

March 23, 2010

Last Update Submit

May 27, 2010

Conditions

Congenital Heart Disease

Keywords

HybridNorwoodcongenital heart diseasesingle ventricle

Outcome Measures

Primary Outcomes (2)

  • Neurologic and functional outcomes

    Neurodevelopmental and functional status will be assessed at 14 months of age using the Bayley Scales of Infant Development®-Third Edition (BSID-III), MacArthur Commmunicative Development Inventory/Words and Gestures (CDI) and Functional Status-II-Revised Questionnaire.

    14 months of age

  • Neurologic and functional outcomes

    At \~3 years of age, the Vineland Scale,the Mullen Developmental Scale, and the BASC behavioural scale will be formally assessed

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

Secondary Outcomes (7)

  • Hemodynamic Assessment

    Baseline and 4-6 months

  • Blood Sampling

    Baseline and 4-6 months

  • Systemic Oxygen Consumption

    Baseline and 4-6 months

  • Cerebral Oxygen Transport Surrogate Measurements

    Baseline and 4-6 months

  • Cerebral Blood Flow Velocity

    Baseline and 4-6 months

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Hybrid Management

Procedure: Hybrid Strategy

Arm 2

ACTIVE COMPARATOR

Norwood Management

Procedure: Norwood management strategy

Interventions

Norwood management strategyPROCEDURE

Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.

Arm 2
Hybrid StrategyPROCEDURE

Hybrid palliation will be performed as per current clinical practice at The Hospital for Sick Children. The 'Hybrid' management strategy utilizes catheter-based and non-open heart surgical procedures in the neonatal period to stabilize the neonate.10 The majority of the reconstruction is thereby deferred to 4-6 months of age, at which time the second stage procedure including an aortic arch reconstruction is performed. The third stage procedure (Fontan) is identical between Norwood and Hybrid strategies.

Arm 1

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Heart Defects, CongenitalUniventricular Heart

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christopher Caldarone

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Caldarone

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

May 31, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations

CA(1)