NCT01835392

Brief Summary

The purpose of this study is to look at whether the use of a simple technique before surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve development of language, motor and thinking skills at 12 months of age. Some research has found that a brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm may help the body to tolerate a longer and more severe shortage of blood (for example, during surgery).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 16, 2020

Status Verified

September 1, 2016

Enrollment Period

6.3 years

First QC Date

April 16, 2013

Last Update Submit

March 12, 2020

Conditions

Heart Defects, Congenital

Keywords

Remote ischemic preconditioningHeart defects, congenitalcardiac surgeryNeurodevelopmental outcomes

Outcome Measures

Primary Outcomes (1)

  • Neurodevelopment

    Neurodevelopmental outcomes at 12 (+/- 1) months of age as measured by the Bayley Scales of Infant and Toddler Development, Third Edition and the Infant Development Inventory

    12 months of age

Study Arms (2)

Remote Ischemic Preconditioning

EXPERIMENTAL

Four 5-minute cycles of leg ischemia interspersed with 5-minute cycles of reperfusion using a blood pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure.

Procedure: Remote Ischemic Preconditioning

Control

SHAM COMPARATOR

Placement of blood pressure cuff around leg without inflation for 40 minutes

Other: Control

Interventions

Remote Ischemic PreconditioningPROCEDURE

Lower limb ischemia/reperfusion cycles

Also known as: RIPC, Remote Ischemic Conditioning
Remote Ischemic Preconditioning
ControlOTHER

Sham placement of blood pressure cuff without inflation

Also known as: Sham
Control

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants \<7 months of age
  • Undergoing open heart surgery
  • Written informed consent

You may not qualify if:

  • Presence of known gross neurologic abnormality preoperatively
  • History of birth asphyxia
  • Non-English speaking family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Cardiac Center

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christian Pizarro, MD

    Nemours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 18, 2013

Study Start

September 1, 2011

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 16, 2020

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)