Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Inf… (NCT05381272) | Clinical Trial Compass
UnknownNot Applicable
Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants
20 participantsStarted 2010-01-01
Plain-language summary
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
However, there is few studies on this subject, especially concerning the neurodevelopment outcomes.
Objective: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR.
Hypothesis : Preterm infants with early and severe antenatal IUGR have more neurodevelopmental delay than infants with no IUGR.
Who can participate
Age range
0 Days – 2 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:
* Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (Audipog curves).
Each infant included will be matched to 2 controls on gestational age, period and sex
Exclusion Criteria:
* no
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
Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale