Effect of Antenatal SSRI Exposure on the QT Interval of Neonates (NCT02492347) | Clinical Trial Compass
CompletedNot Applicable
Effect of Antenatal SSRI Exposure on the QT Interval of Neonates
United Kingdom88 participantsStarted 2016-02-18
Plain-language summary
Selective Serotonin Reuptake Inhibitors (SSRIs) are a group of antidepressants that suppress the re-absorption of a chemical called Serotonin in the brain, and improve mood. SSRI use in the treatment of mental health problems has increased greatly since their introduction in the 1980's. When given in pregnancy they cause less fetal effects than other antidepressants. However they are still known to cause premature birth, heart defects and withdrawal symptoms in the baby. Withdrawal symptoms can occur in up to 30% of exposed babies, where as heart defects have been found to increase by 2-3 times against the normal rate of 1%. There is very limited information available, but it is also thought it may cause lengthening of a certain portion of the heart beat, the QT interval, which has been shown to lead to sudden death in adults. The QT interval will be looked at in this study, comparing babies exposed to SSRIs in pregnancy with unexposed babies.
The study will be based in the United Kingdom (UK), at the Maternity Unit of a District General Hospital, and will be carried out over 12-18 months.
A group of babies whose mothers took SSRIs whilst pregnant will have an Electrocardiogram (ECG) done when they are 2-3 days old. These will be compared with babies whose mothers did not, but whose babies were still in hospital because they were at risk of having an infection, but were found to be healthy.
The study hopes to see whether there is a link between SSRI use in pregnancy and lengthening of the QT interval and if so, extra surveillance may be considered for this group of babies.
Who can participate
Age range
2 Days – 3 Days
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:
* Neonates 37 weeks or more gestation at birth
* Age of parent/ person with parental responsibility being at least 16 years old
* Clinically well parent/ person with parental responsibility
* English Speaking parent/ person with parental responsibility
* Neonate at least 48 hours old
Inclusion criteria for case group participants only:
* Maternal SSRI use at any point in pregnancy
Inclusion criteria for control group participants only:
* Neonate highlighted as at risk of infection and:-
* antibiotic therapy at less than 12 hours old;
* CRP x 2 \<10mg/l;
* negative blood culture at 36-47 hours of age (depending on when antibiotic therapy was . commenced)
* clinically well on examination by ANNP/ Medical team.
Exclusion Criteria:
* Neonates less than 37 weeks gestation at birth
* Age of parent/ person with parental responsibility under 16 years old
* Neonate who is clinically unwell with risk of infection on examination
* Neonate with CRP greater than 10 mg/l
* Neonate with positive blood culture
* Neonate less than 48 hours old
* Maternal cocaine misuse
* Maternal methadone use
* Maternal use of other antidepressants
* Known maternal or fetal structural cardiac abnormality
* Neonate with heart murmur at the time of the planned ECG
* Neonate presenting with congenital abnormality with a high incidence of associated cardiac malformations . . in current pregnancy (e.g., Trisomy 21)
Exclusion criteria for case group participants only:-
* Neona…
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.