Respiratory ComplicationsNCT02060994
Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More
An observational study of Respiratory Complications, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. Goal: The aim of the current study is to find out if these respiratory complications extend to later life. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Respiratory Complications
- How many people
- 123 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Apr 2014
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children born in 2007-2009 in "Hillel Yaffe" medical center by elective Cesarean section according to a list of IDs we have.
Who may be able to join
- Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have.
Who cannot join
- Children with respiratory congenital defect that was not known at the first week of life.
Trial locations and contacts
1 site in 1 country.
About this study
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.
Goal: The aim of the current study is to find out if these respiratory complications extend to later life.
Methode: Reviewing the patients' medical file, and collecting data about respiratory complication.
Read the detailed description
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. We have already conducted a study about this topic, and published our results.
Goal: The aim of the current study is to find out if these respiratory complications extend to later life.
Method: Reviewing the patients' medical file, and collecting data about respiratory complication. We will use the same patients we used at the first study. Respiratory complications are defined as diagnosis of asthma, treatment by inhalations or systemic steroids, or consultation by pulmonologist.
- Conditions
- Respiratory Complications
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 37-38 weeks | Children who were born by elective Cesarean section after 37-38 gestational weeks.
Intervention: No intervention. Receives: Other: No intervention | |
| 39 week or more | Children who were born by elective Cesarean section after 39 gestational weeks or more Intervention: No intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
There are respiratory complications.
Respiratory complications are defined as any of: asthma, inhalation therapy, systemic steroids therapy, consultation by a pulmonologist
Measured: Age 4-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillle Yaffe medical center, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060994
- Sponsor's protocol ID
- HYMC-0088-13-CTIL
- Status last verified
- May 2014
- First submitted
- 8 Feb 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nir V, Nadir E, Feldman M. Late better than early elective term Cesarean section. Acta Paediatr. 2012 Oct;101(10):1054-7. doi: 10.1111/j.1651-2227.2012.02772.x. Epub 2012 Jul 16.
PubMed 22758608
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More
- ClinicalTrials.gov ID
- NCT02060994
- Acronym / sponsor ID
- HYMC-0088-13-CTIL
- Conditions
- Respiratory Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Feb 2014 (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.
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.
Goal: The aim of the current study is to find out if these respiratory complications extend to later life.
Methode: Reviewing the patients' medical file, and collecting data about respiratory complication.
Detailed description
Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. We have already conducted a study about this topic, and published our results.
Goal: The aim of the current study is to find out if these respiratory complications extend to later life.
Method: Reviewing the patients' medical file, and collecting data about respiratory complication. We will use the same patients we used at the first study. Respiratory complications are defined as diagnosis of asthma, treatment by inhalations or systemic steroids, or consultation by pulmonologist.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 37-38 weeks | – | Other: No interventionChildren who were born by elective Cesarean section after 37-38 gestational weeks. Intervention: No intervention. |
| 39 week or more | – | Other: No interventionChildren who were born by elective Cesarean section after 39 gestational weeks or more Intervention: No intervention. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children born in 2007-2009 in "Hillel Yaffe" medical center by elective Cesarean section according to a list of IDs we have.
Key inclusion criteria (1 listed)
- Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have.
Key exclusion criteria (1 listed)
- Children with respiratory congenital defect that was not known at the first week of life.
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 |
|---|---|---|
| No interventionNo intervention | Other | 37-38 weeks, 39 week or more |
Primary outcome
There are respiratory complications.
Time frame: Age 4-8 years
Respiratory complications are defined as any of: asthma, inhalation therapy, systemic steroids therapy, consultation by a pulmonologist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Background: PubMed 22758608Nir V, Nadir E, Feldman M. Late better than early elective term Cesarean section. Acta Paediatr. 2012 Oct;101(10):1054-7. doi: 10.1111/j.1651-2227.2012.02772.x. Epub 2012 Jul 16.
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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.
Erez Nadir, MD principal investigator
Hillle Yaffe medical center, Hadera, Israel
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 Respiratory Complications, run by Hillel Yaffe 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: finished, as of the sponsor's last update on 2 May 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There are respiratory complications. (time frame: Age 4-8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060994, which also lists 1 linked publication.
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 2 May 2014.