Effect of Antenatal SSRI Exposure on the QT Interval of Neonates

NCT02492347 | Completed

• 1 other identifier: 8442
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• QT interval on ECG of 48-72 hours old neonates

  The range of QT intervals for this age group of neonates will be ascertained on ECG. Those outside the accepted norm of 2 deviations from the mean (\>440msecs) will be highlighted as prolonged.

  48-72 hours old

Secondary Outcomes (3)

• SSRIs taken antenatally as stated on the data collection sheet.

  48 -72 hours postpartum

• Gestation at which SSRIs were taken as stated on the data collection sheet.

  48 -72 hours postpartum

• Wellbeing as stated in hospital record at 6 months of age if prolonged QT interval on ECG at 48- 72 hours of age.

  6 months old

Study Arms (2)

Neonates exposed to AN SSRI use

ACTIVE COMPARATOR

A group of newborn babies who have been exposed to SSRIs in pregnancy will receive an Electrocardiogram at 48-72 hours of age.

Procedure: Electrocardiogram

Neonates not exposed to AN SSRI use

OTHER

A group of newborn babies, who require treatment with intravenous antibiotics for at least 36 hours, having been identified as being at risk of having an infection within 12 hours of being born. They are subsequently confirmed as clinically well and will receive an Electrocardiogram at 48-72 hours of age.

Procedure: Electrocardiogram

Interventions

Electrocardiogram PROCEDURE

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.

Neonates exposed to AN SSRI use; Neonates not exposed to AN SSRI use

Eligibility Criteria

• Age: 2 Days - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Maternal SSRI use at any point in pregnancy
• 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.

You may not qualify if:

• 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)
• Neonate highlighted as at risk of infection and requiring antibiotic therapy.
• Maternal use of SSRIs in pregnancy

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

Related Publications (4)

• Dubnov-Raz G, Juurlink DN, Fogelman R, Merlob P, Ito S, Koren G, Finkelstein Y. Antenatal use of selective serotonin-reuptake inhibitors and QT interval prolongation in newborns. Pediatrics. 2008 Sep;122(3):e710-5. doi: 10.1542/peds.2008-0658.

  PMID: 18762507 BACKGROUND

• Lattimore KA, Donn SM, Kaciroti N, Kemper AR, Neal CR Jr, Vazquez DM. Selective serotonin reuptake inhibitor (SSRI) use during pregnancy and effects on the fetus and newborn: a meta-analysis. J Perinatol. 2005 Sep;25(9):595-604. doi: 10.1038/sj.jp.7211352.

  PMID: 16015372 BACKGROUND

• Tuccori M, Testi A, Antonioli L, Fornai M, Montagnani S, Ghisu N, Colucci R, Corona T, Blandizzi C, Del Tacca M. Safety concerns associated with the use of serotonin reuptake inhibitors and other serotonergic/noradrenergic antidepressants during pregnancy: a review. Clin Ther. 2009 Jun;31 Pt 1:1426-53. doi: 10.1016/j.clinthera.2009.07.009.

  PMID: 19698902 BACKGROUND

• Udechuku A, Nguyen T, Hill R, Szego K. Antidepressants in pregnancy: a systematic review. Aust N Z J Psychiatry. 2010 Nov;44(11):978-96. doi: 10.3109/00048674.2010.507543.

  PMID: 21034181 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 8, 2015
• Study Start: February 18, 2016
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

GB (1)