MedTrace Logo

Effect of Antenatal SSRI Exposure on the QT Interval of Neonates

NCT02492347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Qt Interval, Variation in
  • Adverse Effect of Selective Serotonin Reuptake Inhibitors

Interventions

PROCEDURE

Electrocardiogram

The ECG is a non-invasive screening tool. It will be performed when the neonate is settled and comfortable. The electrodes used are made with soft jelly adhesive which is stored at room temperature. The procedure will be conducted in a timely manner, taking no longer than 15 minutes. The electrodes are easily removed, and the neonate redressed.

Sponsors & Collaborators

  • University of Southampton

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-18
Primary Completion
2017-08-18
Completion
2017-08-18

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02492347 on ClinicalTrials.gov