Respiratory Outcome of Children From the FEPED Cohort (NCT03229317) | Clinical Trial Compass
CompletedNot Applicable
Respiratory Outcome of Children From the FEPED Cohort
France142 participantsStarted 2018-01-31
Plain-language summary
Early lung function deficits represent a significant risk factor for the evolution toward chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke exposure are already known to predispose children to develop a non-reversible obstructive ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less certain. In humans, low vitamin D concentrations during pregnancy are associated to an increased risk of asthma in children. In murine models, low vitamin D concentrations during pregnancy are associated to structural abnormalities of the airways in mouse pups. Investigators hypothesized that vitamin D play a role in early airways development, from the first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will study the association of airway resistance in children aged 5 to 6 years old with the concentration of vitamin D during the first trimester of pregnancy in their mothers.
Who can participate
Age range
5 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was included in the FEPED cohort
* measure of vitamin D concentration available at the first and third trimester of pregnancy and in cord blood
* cord blood sample available for DNA extraction
* child's age between 5 and 6 years old at the time of participation
* written informed consent obtained from the legal guardian of the child
* health insurance
Exclusion Criteria:
* parent's' refusal
* underlying disease that does not allow the performance of lung function tests
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Specific airway resistance measured by plethysmography