NCT02060994

Brief 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. Methode: Reviewing the patients' medical file, and collecting data about respiratory complication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

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

February 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

February 8, 2014

Last Update Submit

May 1, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • There are respiratory complications.

    Respiratory complications are defined as any of: asthma, inhalation therapy, systemic steroids therapy, consultation by a pulmonologist

    Age 4-8 years

Study Arms (2)

37-38 weeks

Children who were born by elective Cesarean section after 37-38 gestational weeks. Intervention: No intervention.

Other: No intervention

39 week or more

Children who were born by elective Cesarean section after 39 gestational weeks or more Intervention: No intervention.

Other: No intervention

Interventions

No intervention

37-38 weeks39 week or more

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children born in 2007-2009 in "Hillel Yaffe" medical center by elective Cesarean section according to a list of IDs we have.

You may qualify if:

  • Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have.

You may not qualify if:

  • Children with respiratory congenital defect that was not known at the first week of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, North, 38100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 22758608BACKGROUND

Study Officials

  • Erez Nadir, MD

    Hillle Yaffe medical center, Hadera, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

February 8, 2014

First Posted

February 12, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 2, 2014

Record last verified: 2014-05

Locations