Form 1: Trial Entry. Baby-OSCAR study number: Hospital name:

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Todd Small
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1 Please complete in black ballpoint pen Hospital name: Points to remember: Until completed, keep this form in the Working documents section of the Baby-OSCAR Documentation Box. This form must be completed within 7 days of randomisation and returned to the Trial Co-ordinating Centre using a FREEPOST envelope from the Baby-OSCAR Documentation Box. Please remember to complete the Eligibility log from the Baby-OSCAR Documentation Box. If you make a mistake when completing this form, strike through once and initial and date the correction. Please ensure all questions on this form are answered; this will avoid unnecessary work in chasing missing data. For NPEU office use Date Initials If you have any questions please contact the Co-ordinating Centre on Logged 1st entry 2nd entry Baby-OSCAR Page 1 of 5 Version 1, 01 June 2015

2 Baby s first name (if known): Last name: Baby s NHS or CHI number (if known): Baby s hospital ID number in this hospital: Section A: Eligibility Please complete this section before logging on to the Baby-OSCAR website to obtain the study number. A1. What was the expected date of delivery (EDD)? (derived from first ultrasound dating scan if possible) A2. What was the actual date and time of birth? A3. What is the baby s sex? Male Female Indeterminate D D : M M Hr Min A4. What was the size of the PDA? (must be 1.5 mm). mm (Record the average from 3 measurements) A5. Was the ductal flow unrestrictive pulsatile and left to right? Yes No Must be YES A6. Mode of respiratory support at time of randomisation: (tick one of the following only) Invasive ventilation (by ET tube) Non-invasive respiratory support only (nasal ventilation or CPAP or high flow oxygen therapy) Receiving no respiratory support (in room air, or low flow, or ambient oxygen) Unknown A7. Was the baby one of a multiple pregnancy? (If No, go to question A8) Yes No If Yes, how many babies were born? What was the birth order of this baby? Has a sibling already been recruited? Yes No If Yes, please list all their study numbers: A8. Is the baby currently receiving inotropes? Yes No A9. Is the responsible clinician uncertain about whether this baby might benefit from treatment to close the PDA? Yes No Must be YES A10. Do you have written parental consent for the baby s participation? Yes No Must be YES A11. Does the baby have a realistic prospect of survival? Yes No Must be YES A12. Does the baby have a severe congenital anomaly? Yes No Must be NO Baby-OSCAR Page 2 of 5 Version 1, 01 June 2015

3 A13. Is there any clinical or echocardiographic suspicion of congenital structural heart disease that contraindicates treatment with ibuprofen? Yes No Must be NO A14. Does the baby have any known conditions that would contraindicate the use of ibuprofen? Yes No Must be NO A15. Was the baby administered indomethacin, ibuprofen or paracetamol after birth? If the baby is NOT eligible DO NOT proceed Yes No Must be NO A16. This baby meets the inclusion criteria and none of the exclusion criteria: Name: (Print) Signature: Role: Date: Section B: Randomisation After completion of Section A, log on to and follow the onscreen instructions. The randomisation system will provide you with a unique study number for this baby and a pack ID for the Baby-OSCAR trial treatment, which you should fill in below. B1. Baby-OSCAR study number: B2. Trial intervention pack ID (1 letter, 4 digits) Administer the first dose soon after randomisation and within 72 hours Section C: Obstetric details C1. Was the mother given any antenatal steroids to improve fetal maturation? (tick one of the following only) No Yes started less than 24hrs before birth Yes started 24hrs or more before birth Unknown C2. Did the mother receive any COX inhibitors antenatally? Yes No Section D: Neonatal details D1. Was the baby born in this hospital? Yes No If No, where was the baby born? D2. What was the baby s mode of delivery? (tick one of the following only) Vaginal birth cephalic Vaginal birth breech Caesarean section before onset of labour Caesarean section after onset of labour D3. Were Forceps or Ventouse used in the delivery? Yes No Baby-OSCAR Page 3 of 5 Version 1, 01 June 2015

4 D4. What was the main cause of the preterm birth? (tick one of the following only) Prelabour rupture of membranes (PROM) Obstetric intervention for maternal reasons Other Please specify Preterm labour (without PROM) Obstetric intervention for fetal reasons D5. What was the baby s birth weight in grams? g D6. What was the Apgar score at 5 minutes? Unknown D7. What was the baby s worst base excess in the first hour after birth? (if positive change - to +) -. Not recorded Section E: Maternal details E1. Mother s first name: Last name: E2. Mother s NHS number or CHI: (if known) E3. Mother s date of birth: E4. House number / Name: Street: County: Town: Postcode: E5. Landline number: E6. Contact mobile numbers: E7. Contact address: E8. Preferred method of contact: Phone Mobile Post E9. Mother s ethnic group: (enter code; see definitions) E10. Mother s main language: Definitions Ethnic group codes WHITE 01. British / Irish 02. White other MIXED 03. White and Black Caribbean 04. White and Black African 05. White and Asian 06. Mixed other ASIAN 07. Indian 08. Pakistani 09. Bangladeshi 10. Chinese 11. Asian other BLACK 12. Caribbean 13. African 14. Black other OTHER ETHNIC GROUP 15. Arab 16. Other ethnic category Baby-OSCAR Page 4 of 5 Version 1, 01 June 2015

5 Section F: Continuing care F1. Is this baby likely to get transferred out? Yes No If Yes, please list the name(s) of the hospital(s) where the baby may transfer to: Section G: Form completion Details of person completing the form and person responsible for carrying out the ECHO. G1. Name of person carrying out the ECHO: (Print) G2. Date this form was completed: G3. Name of person completing this form: Name: (Print) Signature: G4. What is the best way of contacting you? Role: What to do now 1. Please send the original of this completed form to the Baby-OSCAR Co-ordinating Centre using the FREEPOST envelope provided. 2. When the baby is discharged from hospital, dies or is transferred to another hospital, please complete Form 6: Baby Outcomes. Thank you for completing this form. If this baby experiences any serious unexpected adverse events please complete one of the Serious Adverse Event Forms in the Baby-OSCAR Documentation Box and fax it to the Co-ordinating Centre immediately. Freepost RLSL-SBZK-HTAT Baby-OSCAR Co-ordinating Centre, NPEU Clinical Trials Unit, University of Oxford, Old Road, Headington, Oxford, OX3 7LF Tel: Fax: Baby-OSCAR is funded by the National Institute for Health Research HTA Programme (project reference 11/92/15) Baby-OSCAR Page 5 of 5 Version 1, 01 June 2015

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