ClubfootSCFNCT01050088
Sucrose Analgesia in Infants Undergoing Casting for Club Foot
A study testing sucrose solution and Saline in people with Clubfoot, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks to 12 months
- Conditions the study is for
- Clubfoot
- What is being tested?
- sucrose solution and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All otherwise healthy babies who need casting for congenital clubfeet
Who cannot join
- All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Schneider Children's Medical Center
Petah Tikva
Daniel M Weigl, MD, 972-3-9253759, danielw@clalit.org.il
Daniel M Weigl, MD
About this study
Official title: Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot
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.
Read the detailed description
Babies who were born with congenital clubfeet are currently being treated by the conventional Ponseti method. This procedure is done in an outpatient clinic setup. The procedure is painless but may cause some discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies. The control group will consist of patients who will get 5cc saline pre cast application, while the study group will be given 5cc of Sucrose solution. Patients and physicians are blinded to the treatment they get. Outcome measures will include pulse rate and oxygenation as an accepted measure of discomfort.
- Conditions
- Clubfoot
- Being tested
- sucrose solution, Saline
- Keywords
- clubfoot, casting, ponseti, discomfort
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucrose solutionDietary supplement
5cc 5% sucrose solution P/O
SalineDietary supplement
Also called 5cc Saline solution
5cc saline p/o
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | 5cc sucrose solution Receives: Dietary Supplement: sucrose solution |
| Saline | Placebo comparator | 5cc saline p/o Receives: Dietary Supplement: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse rate, Blood oxygenation
Measured: During casting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Danielw M Weigl, MD, Principal investigator, Schneider Children's Medical CenterKalman Katz, Prof., Study director, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050088
- Sponsor's protocol ID
- 005411
- Acronym
- SCF
- Status last verified
- Jan 2010
- First submitted
- 14 Jan 2010
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot
- ClinicalTrials.gov ID
- NCT01050088
- Acronym / sponsor ID
- SCF / 005411
- Conditions
- Clubfoot
- Keywords
- clubfoot, casting, ponseti, discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Babies who were born with congenital clubfeet are currently being treated by the conventional Ponseti method. This procedure is done in an outpatient clinic setup. The procedure is painless but may cause some discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies. The control group will consist of patients who will get 5cc saline pre cast application, while the study group will be given 5cc of Sucrose solution. Patients and physicians are blinded to the treatment they get. Outcome measures will include pulse rate and oxygenation as an accepted measure of discomfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Dietary Supplement: sucrose solution5cc sucrose solution |
| Saline | Placebo comparator | Dietary Supplement: Saline5cc saline p/o |
Who may qualify
- Ages
- 4 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All otherwise healthy babies who need casting for congenital clubfeet
Key exclusion criteria (1 listed)
- All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucrose solution5cc 5% sucrose solution P/O | Dietary supplement | Sucrose |
| SalineAlso: 5cc Saline solution5cc saline p/o | Dietary supplement | Saline |
Primary outcome
Pulse rate, Blood oxygenation
Time frame: During casting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielw M Weigl, MD principal investigator
Schneider Children's Medical Center
Kalman Katz, Prof. study director
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrose solution and Saline in people with Clubfoot, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Weigl, MD (972-3-9253759, danielw@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse rate, Blood oxygenation (time frame: During casting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.