NCT01050088

Brief Summary

Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies.

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
20

participants targeted

Target at below P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

6 months

First QC Date

January 14, 2010

Last Update Submit

January 14, 2010

Conditions

Clubfoot

Keywords

clubfootcastingponsetidiscomfort

Outcome Measures

Primary Outcomes (1)

  • Pulse rate, Blood oxygenation

    During casting

Study Arms (2)

Sucrose

EXPERIMENTAL

5cc sucrose solution

Dietary Supplement: sucrose solution

Saline

PLACEBO COMPARATOR

5cc saline p/o

Dietary Supplement: Saline

Interventions

sucrose solutionDIETARY_SUPPLEMENT

5cc 5% sucrose solution P/O

Sucrose
SalineDIETARY_SUPPLEMENT

5cc saline p/o

Also known as: 5cc Saline solution
Saline

Eligibility Criteria

Age4 Weeks - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All otherwise healthy babies who need casting for congenital clubfeet

You may not qualify if:

  • All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Clubfoot

Interventions

sodium lactobionate sucrose solutionSodium Chloride

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Danielw M Weigl, MD

    Schneider Children's Medical Center

    PRINCIPAL INVESTIGATOR

  • Kalman Katz, Prof.

    Schneider Children's Medical Center

    STUDY DIRECTOR

Central Study Contacts

Daniel M Weigl, MD

CONTACT

972-3-9253759danielw@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

IL(1)