Form 6: Baby Outcomes Outcomes at THIS hospital

Transcription

1 Form 6: Baby Outcomes Outcomes at THIS hospital Please complete in black ballpoint pen Hospital name: Form 6: Baby Outcomes Please complete this form when a Baby-OSCAR participant is transferred to another hospital, or discharged home, or dies. Points to remember: Only events occurring in this hospital should be recorded. If the baby reached 36 weeks of postmenstrual age, or was discharged home before this date, while at your hospital, please ensure you complete Section D of this form AND Form 4: 36 Week Form. 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. Form 6: Baby Outcomes If you have any questions please contact the Co-ordinating Centre on For NPEU office use Logged 1st entry 2nd entry Date Initials Baby-OSCAR Form 6: Baby Outcomes Page 1 of 8 Version 2.0, 12-Jan-2017

2 Section A: Baby details A1. Baby-OSCAR study number: A2. Baby s date of birth: A3. Baby s first name (if known): Last name: A4. Baby s NHS or CHI number (if known): A5. Baby s hospital ID number in this hospital: A6. Date baby was admitted to your unit: A7. While in this hospital, was the baby in any other trial/study? Yes No If Yes, please state the trial/study name(s): Section B: While in this hospital Please complete this section during this admission only. Cerebral B1. While in this hospital, did the baby have any cerebral ultrasound scans? Yes No If Yes, please confirm the number of ultrasound scans carried out? What was the date of the last ultrasound scan at this hospital? Identify below any abnormalities seen on the latest scan in this hospital Tick at least one box in each column: Left Right None of the abnormalities listed below seen Intraventricular Haemorrhage (IVH), Grade I or II without ventricular dilatation Severe Intraventricular Haemorrhage (IVH) with ventricular dilatation (Grade III) Intraventricular Haemorrhage (IVH) with intraparenchymal abnormality (Grade IV) Hydrocephalus (ventricular index > 4 mm above 97th centile*) Cystic Periventricular Leukomalacia (PVL) Non-cystic PVL Other white matter injury, please specify Ophthalmology B2. While in this hospital, was the baby screened for Retinopathy of Prematurity (ROP)? Yes No Not eligible i. If Yes, what was the worst stage of ROP in each eye? No ROP Stage I Stage II Right eye Left eye More staging over page Baby-OSCAR Form 6: Baby Outcomes Page 2 of 8 Version 2.0, 12-Jan-2017

3 Stage II, plus disease present Stage III Stage III, plus disease present Stage IV Stage V Right eye Left eye ii. Please confirm any of the following Right eye Left eye AP-ROP Has the ROP been treated? Yes No Yes No B3. Has the baby received any preventative treatment for ROP? Yes No If Yes, tick at least one Anti VEGF Other, please specify ROP Staging Stage 1: Demarcation line - Thin relatively flat line separating the vascular and avascular retina. Abnormal branching or arcading of vessels may lead up to the demarcation line. Stage 2: Ridge - The ridge has height and width extending above the retina. lsolated tufts of neovascular tissue - popcorn - may be seen posterior to the ridge. Stage 3: Extraretinal Fibrovascular Proliferation - In this stage extraretinal fibrovascular proliferation or neovascularization extends from the ridge, into the vitreous. Stage 4: Partial Retinal Detachment - Stage 4: extrafoveal (stage 4a) and foveal (stage 4b) partial retinal detachments. Stage 5: Total Retinal Detachment AP (Aggressive Posterior) ROP - An uncommon, rapidly progressing, severe form of ROP characterised by its posterior location, prominence of plus disease and the ill defined nature of the retinopathy Pre-plus and Plus disease Signs indicative of ROP activity including increased venous dilation and arteriolar tortuosity of the posterior retinal vessels which may later increase in severity to include iris vascular engorgement, poor pupillary dilation (rigid pupil), and vitreous haze. Changes in 2 vessel quadrants equivalent to the standard photograph (see Figure 2 in guideline photo glossary & Arch Ophthalmol 2005; 123: ) are required for the diagnosis of plus. Pre-plus changes are vascular abnormalities of the posterior pole that are insufficient for the diagnosis of plus disease, but that cannot be considered normal. From UK Retinopathy of Prematurity Guideline May 2008 Baby-OSCAR Form 6: Baby Outcomes Page 3 of 8 Version 2.0, 12-Jan-2017

4 Supplementary oxygen and respiratory support When counting days use the highest level of support used e.g if a baby is ventilated for 1 hour, then on CPAP for the rest of the day, both would be counted. B4. Were any steroids used postnatally to treat chronic lung disease? Yes No If Yes, please confirm the date(s) administered: Start date (DD/MM/YY) Ongoing End date (DD/MM/YY) B5. While in this hospital, was the baby diagnosed with a significant pulmonary haemorrhage? Yes No (Defined as fresh blood in endotracheal tube with increase in respiratory support) If Yes, please confirm the date of the first pulmonary haemorrhage: B6. While in this hospital, the number of days receiving invasive ventilation by endotracheal tube? days B7. While in this hospital, the number of days receiving non-invasive respiratory support (nasal CPAP, nasal ventilation, humidified high flow nasal cannula therapy or low flow oxygen 1.1L/min)? B8. While in this hospital, the number of days receiving ambient or low flow oxygen (< 1.1 L/min)? Cardiovasular B9. While in this hospital, did the baby receive treatment for PDA (after receiving trial medication)? Complete Form 5: Open Treatment of PDA Yes B10. While in this hospital, were any diuretics used for the management of a PDA? Yes No B11. While in this hospital, was any inotropic support administered? Yes No Number of days receiving inotropic support (1 day > 12 hours)? B12. While in this hospital, did the baby have any ECHOs? Yes No If Yes, i. Please state the number of ECHOs carried out at this hospital ii. Please confirm the date of the last ECHO B13. While in this hospital, was the baby diagnosed with pulmonary hypertension? Yes No If Yes, i. How was pulmonary hypertension diagnosed? Clinically Echocardiographically ii. Was the baby treated for pulmonary hypertension with a pulmonary vasodilator? Yes No No days days days Baby-OSCAR Form 6: Baby Outcomes Page 4 of 8 Version 2.0, 12-Jan-2017

5 If Yes, please tick all that apply Treated with Nitric Oxide Other treatment If Other, please specify iii. Please confirm the date the pulmonary hypertension was treated for the first time Gastrointestinal B14. While in this hospital, were there any episodes of NEC (definitive, Bell stage II or III)? Yes No If Yes, please confirm the number of episodes Record below the date(s) of each episode(s): Start date (DD/MM/YY) Ongoing End date (DD/MM/YY) Please ensure you complete Form 6a: NEC Report Form for each episode identified above B15. While in this hospital, were there any episodes of a spontaneous intestinal perforation? Yes No If Yes, please confirm the date: Was surgical management undertaken? Yes No Other information B16. While in this hospital, during this admission, how many days did this baby receive: Level 1 (intensive) care Level 2 (high dependency) care Level 3 (special) care B17. Was the baby treated with antibiotics > 5 days continuously? Yes No If Yes, how many courses? Section C: Additional information/continuation section Baby-OSCAR Form 6: Baby Outcomes Page 5 of 8 Version 2.0, 12-Jan-2017

6 Section D: Outcome D1. Please confirm the outcome for this baby, whilst in your hospital for this period: (Please complete one of the following outcomes for this hospital stay) Discharged home: A i. Date of discharge: ii. Discharged home on oxygen? Yes iii. Weight g Date of measurement: iv. Head circumference. cm Date of measurement: No Not recorded Transferred to another hospital: i. Date of transfer: ii. Name of receiving hospital: B iii. City/town of receiving hospital: iv. Name of receiving consultant (if known): v. While in hospital, what was the last day the baby received more than 12hrs of supplementary oxygen? Still on oxygen Never on oxygen at this hospital Died: C i. Date of death: Please send a copy of the discharge summary and, if available, the post-mortem report to the Co-ordinating Centre ii. Is a discharge summary enclosed? Yes No iii. Is a post-mortem Yes No Not planned Not performed report enclosed? Baby-OSCAR Form 6: Baby Outcomes Page 6 of 8 Version 2.0, 12-Jan-2017

7 Section F: Contact details Mother First name: Last name: Address: Family Doctor Title: First name: Last name: Address: Postcode: Telephone: Mobile NHS or CHI Number: Postcode: Telephone: Other family member Tick if address is same as Mother Address (only): Other Tick if address is same as Mother Address (only): Postcode: Telephone: Mobile Relationship to baby: Father Other relative Neighbour Other Please specify Grandparent Family friend Postcode: Telephone: Mobile Relationship to baby: Father Other relative Neighbour Other Please specify Grandparent Family friend Section E: Form completion E1. Date this form was completed: E2. Name of person completing this form: (Print) Signature: E3. What is the best way of contacting you? Phone Contact number: address: Role: Baby-OSCAR Form 6: Baby Outcomes Page 7 of 8 Version 2.0, 12-Jan-2017

8 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, complete Form 6: Baby Outcomes. Thank you for completing this form. Freepost RLSL-SBZK-HTAT Baby-OSCAR Co-ordinating Centre, NPEU Clinical Trials Unit, University of Oxford, Old Road, Headington, Oxford, OX3 7LF Tel: Fax: *Ventricular Index: The ventricular index is the distance between the middle and the most lateral point of the lateral ventricle in millimetres measured in the coronal (or the axial) plane at the level of the foramen Munro. Cystic PVL: Macroscopic focal necrotic lesions that evolve into cystic formation Non-cystic PVL: Focal necrotic component that evolves into a glial scar but not into cyst formation Baby-OSCAR is funded by the National Institute for Health Research HTA Programme (project reference 11/92/15) Baby-OSCAR Form 6: Baby Outcomes Page 8 of 8 Version 2.0, 12-Jan-2017