This DATSETNAMEreadme.txt file was generated on 15072019 by Marie Lindsay-Sutherland ------------------- GENERAL INFORMATION ------------------- Title of Dataset: Dataset for "Is Antenatal Exposure to Selective Serotonin Reuptake Inhibitors Associated with A Prolonged QT Interval in Term Neonates (37 Weeks Gestation or Greater) When It Is Assessed on an Electrocardiogram at 48 – 72 Hours of Age" Author Information (Name, Institution, Address, Email) Principal Investigator: Marie Lindsay-Sutherland. Poole NHS Foundation Trust Hospital. Neonatal Unit, St Mary's Rd, Poole, BH15 2JB. Marie.Lindsay-Sutherland@poole.nhs.uk Associate or Co-investigator: Alternate Contact(s): Date of data collection (single date, range, approximate date): 17022016- 16022018 Geographic location of data collection: United Kingdom Information about funding sources or sponsorship that supported the collection of the data: -------------------------- SHARING/ACCESS INFORMATION -------------------------- Licenses/restrictions placed on the data, or limitations of reuse: Embargo to match that of ethesis Recommended citation for the data: Marie Lindsay-Sutherland (2019) Dataset for "Is Antenatal Exposure to Selective Serotonin Reuptake Inhibitors Associated with A Prolonged QT Interval in Term Neonates (37 Weeks Gestation or Greater) When It Is Assessed on an Electrocardiogram at 48 – 72 Hours of Age" URI [dataset] Citation for and links to publications that cite or use the data: Links to other publicly accessible locations of the data: Links/relationships to ancillary or related data sets: -------------------- DATA & FILE OVERVIEW -------------------- File list : Workbook for case results- SSRI Exposed Data collected from women who had taken SSRIs in pregnancy. Includes data on medical history, pregnancy, birth, and neonatal details including QT interval value. Workbook for control results- Suspected Sepsis Data collected from neonates who were treated for suspected sepsis in the early postnatal period, and their mothers. Includes data on medical history, pregnancy, birth, and neonatal details including QT interval value. Parent Information Leaflet for Case Group Parent Information Leaflet for Control Group Blank Consent form for Case Group Blank Consent form for Control Group Relationship between files, if important for context: One workbook is data for control group of study and the other is data for case group. The other files are the information leaflets given to both study groups to explain the study and what participation entailed, and the consent forms that were signed to confirm agreement to participate. Additional related data collected that was not included in the current data package: If data was derived from another source, list source: If there are there multiple versions of the dataset, list the file updated, when and why update was made: -------------------------- METHODOLOGICAL INFORMATION -------------------------- Description of methods used for collection/generation of data: Data collection questionaire and neonatal ECG. Methods for processing the data: Data from data collection questionaire and neonatal ECG was added to an EXCEL database with anonymisation Software- or Instrument-specific information needed to interpret the data, including software and hardware version numbers: Standards and calibration information, if appropriate: Environmental/experimental conditions: Describe any quality-assurance procedures performed on the data: People involved with sample collection, processing, analysis and/or submission: Data collection team of clinically skilled practioners who normally provide care for these patient groups. In addition, these practitioners underwent GCP training. The PI processed and analysed the data. Statistical advice was sought from the Statistician @ UoS -------------------------- DATA-SPECIFIC INFORMATION -------------------------- Number of variables: Workbook for case results SSRI Exposed (n=26). Workbook for control results Suspected Sepsis (N=26) Number of cases/rows: Workbook for case results SSRI Exposed (n=43). Workbook for control results Suspected Sepsis (N=45) Variable list, defining any abbreviations, units of measure, codes or symbols used: Workbook for case results SSRI Exposed- Age; Ethnicity; Medical History; Family Medical History; Which SSRI; Dosage; When started SSRI; When stopped SSRI; Comments relating to SSRI; What other medications are they taking; Alcohol in pregnancy; Units of alcohol per week; Smoker?; How many cigs (cigerettes) per day; Does partner smoke?; Recreational drugs in pregnancy; What recreational drugs? When?; Ever used recreational drugs; Antenatal US (Ultrasound) NAD (normal)?; Gestation at birth; Delivery; Gender; Baby's wt (weight); neonatal problems; NNEX (neonatal examination) NAD (normal); Mode of feeding; Age in hours at time of ECG (Electrocardiograph); QTc (QT interval) on ECG (Electrocardiograph) msecs (milliseconds); Confirmed QTc (QT interval) msecs (milliseconds); Follow up required; Timeframe for follow up. Workbook for control results Suspected Sepsis- Age; Ethnicity; Medical History; Family Medical History; What other medications are they taking; Alcohol in pregnancy; Units of alcohol per week; Smoker?; How many cigs (cigerettes) per day; Does partner smoke?; Recreational drugs in pregnancy; What recreational drugs? When?; Ever used recreational drugs; Antenatal US (Ultrasound) NAD (normal)?; Gestation at birth; Delivery; Gender; Baby's wt (weight); neonatal problems; NNEX (neonatal examination) NAD (normal); Why Abx (antibiotics) started?; Blood culture -ve (negative) at 48 hours; Mode of feeding; Age in hours at time of ECG (Electrocardiograph); QTc (QT interval) on ECG (Electrocardiograph) msecs (milliseconds); Confirmed QTc (QT interval) msecs (milliseconds); Follow up required; Timeframe for follow up. Missing data codes: Specialized formats or other abbreviations used: