Congenital ChylothoraxNCT00267345
Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax
An observational study of Congenital Chylothorax, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. Read more about this study
- Who is it for?
- Ages 1 hour to 10 weeks
- Conditions the study is for
- Congenital Chylothorax
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2005to Oct 2007
- Phase
- Observational
- 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 1 hour to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with congenital chylothorax requiring thorax drain
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Jacob Kuint, MD, 972-3-5302227, kuint-j@sheba.health.gov.il
Ayala Maayan, MD
About this study
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.
Read the detailed description
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.
- Conditions
- Congenital Chylothorax
- Medical subject headings
- Chylothorax, congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startMar 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital ChylothoraxStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Jacob Kuint, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267345
- Sponsor's protocol ID
- SHEBA-05-3927-JK-CTIL
- Status last verified
- Jan 2006
- First submitted
- 19 Dec 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax
- ClinicalTrials.gov ID
- NCT00267345
- Acronym / sponsor ID
- SHEBA-05-3927-JK-CTIL
- Conditions
- Congenital Chylothorax
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2005
- Study completion
- Oct 2007
- First posted
- 20 Dec 2005 (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.
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.
Detailed description
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with congenital chylothorax requiring thorax drain
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
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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.
Jacob Kuint, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Chylothorax, run by Sheba 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 1 Mar 2007. 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. 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 Jacob Kuint, MD (972-3-5302227, kuint-j@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 1 Mar 2007.