TOBY. Daily log. Data Collection Booklet. This form should be completed from the time the baby is randomised until 80 hours after randomisation

Transcription

1 ISRCTN Hospital ID Sticker TOBY Daily log Data Collection Booklet This form should be completed from the time the baby is randomised until 80 hours after Baby s first name: Baby s surname: Centre number: TOBY Study number (found on baby s notes): Phase 2

2 Timetable for collection of data Parameter Randomisation Hourly 12 Hourly Daily As clinically indicated Laboratory parameters Cerebral USS ECG Respiratory Function Metabolic parameters Urine output Rectal Temp. Cooling Equipment/ ambient temp. Heart rate Mean BP Systolic BP Diastolic BP Drugs and Volume replacement Investigations for sepsis NB. PLEASE READ THE NOTES ON COMPLETION OF THIS BOOKLET INSIDE THE BACK COVER

3 Date and time of : Has the baby been allocated cooling? Yes If yes, what date and time did the cooling start? Was the baby born in this treatment centre? Yes If no, In which hospital was the baby born? Date and time of admission to treatment centre? What grades of staff were on the TOBY transport team that brought the baby in (please enter the number of each grade that participated in the transfer): Consultant Registrar Neonatal nurse grade: E F G Other? Please give details: 1

4 Day 1 This period commenced on: Time since At Rectal temp ( o C) Cooling equipment/ Ambient temp ( o C) Cardiovascular parameters Heart rate (bpm) Mean BP (mmhg) Systolic BP (mmhg) Diastolic BP (mmhg) 1 hour 2 hours 3 hours 4 hours 5 hours 6 hours 7 hours 8 hours 9 hours 10 hours 11 hours 12 hours 2 13 hours 14 hours 15 hours 16 hours 17 hours 18 hours 19 hours 20 hours 21 hours 22 hours 23 hours

5 Codes Ad = Adrenaline DM = Diamorphine A = Albumin Dex = Dexamethasone B = Whole Blood Db = Dobutamine CH= Chloral Hydrate D = Dopamine C = Colloid L = Lignocaine M = Morphine Code Dose Day 1 Drugs and Volume replacement Mz = Midazolam P = Phenobarbitone PC = Packed Cells Pt = Phenytoin S = Saline O = Other - Please specify in comment box overleaf Please see measurement units to be used and notes on page 19 Agent 1 Agent 2 Agent 3 Agent 4 Agent 5 Code Dose Code Dose Code Dose Code Dose NB: Day 1 continues overleaf 3

6 Laboratory parameters - to be taken at (see codes below) Haematology Coagulation Hb (g/dl) PT (seconds) Hct Total WBC PTT (seconds) Neut. count Day 1 Platelets Fibrinogen Ultrasound scan ECG Ultrasound performed at? Yes Time of scan (Please take an extra hard copy to return with the daily log.) Was an ECG done in this 24hr period? Yes If yes, was an arrhythmia present? Biochemistry Yes Na K Creat. Gluc. ALT (mmol/l) (mmol/l) (mmol/l) (mmol/l) (iu/l) If yes, describe the arrhythmia: Positive Cultures: (Record positive cultures taken on this day.) Date and time sample collected Source e.g. blood, CSF Organism identified Codes Hb = Haemoglobin Hct = Haematocrit WBC = White Blood Count Neut. Count = Neutrophil Count PT = Prothrombin Time Creat.= Creatinine Na = Sodium Gluc. = Glucose K = Potassium ALT = Alanine aminotransferase PTT = Partial Thromboplastin Time 4

7 Respiratory function Day 1 Time since reading taken Type of ventilation FiO2 Randomisation 12 hours Metabolic parameters Time since Source of sample (tick one box) ph pco 2 (kpa) po 2 (kpa) Base deficit (circle to show +ve or -ve) # Randomisation cap. art. ven / - 12 hours cap. art. ven / - Urine Output # most recent results can be recorded here Urine output 0-11 hours Urine output hours mls mls Comments: Continuing consent process: Follow-up meeting with parents arranged? Yes 5

8 This period commenced on: Day 2 Time since Rectal temp ( o C) Cooling equipment/ Ambient temp ( o C) Cardiovascular parameters Heart rate (bpm) Mean BP (mmhg) Systolic BP (mmhg) Diastolic BP (mmhg) s 25 hours 26 hours 27 hours 28 hours 29 hours 30 hours 31 hours 32 hours 33 hours 34 hours 35 hours 36 hours 6 37 hours 38 hours 39 hours 40 hours 41 hours 42 hours 43 hours 44 hours 45 hours 46 hours 47 hours

9 ISRCTN Code Dose Day 2 Codes Drugs and Volume Ad = Adrenaline DM = Diamorphine Mz = Midazolam A = Albumin Dex = Dexamethasone P = Phenobarbitone replacement B = Whole Blood Db = Dobutamine PC = Packed Cells Please see measurement units CH= Chloral Hydrate D = Dopamine Pt = Phenytoin to be used and notes on page 19 C = Colloid L = Lignocaine S = Saline M = Morphine O = Other - Please specify in comment box overleaf Agent 1 Agent 2 Agent 3 Agent 4 Agent 5 Code Dose Code Dose Code Dose Code Dose NB: Day 2 continues overleaf 7

10 Day 2 Laboratory parameters - to be taken at s post (see codes below) Haematology Hb (g/dl) Hct Total WBC Neut. count Platelets Ultrasound scan Ultrasound performed at s? Yes Time of scan (Please take an extra hard copy to return with the daily log.) Coagulation ECG PT (seconds) PTT (seconds) Fibrinogen Was an ECG done in this 24hr period? Yes If yes, was an arrhythmia present? Biochemistry Yes Na K Creat. Gluc. ALT (mmol/l) (mmol/l) (mmol/l) (mmol/l) (iu/l) If yes, describe the arrhythmia: Positive Cultures: (Record positive cultures taken on this day.) Date and time sample collected Source e.g. blood, CSF Organism identified Codes Hb = Haemoglobin Hct = Haematocrit WBC = White Blood Count Neut. Count = Neutrophil Count PT = Prothrombin Time Creat.= Creatinine Na = Sodium Gluc. = Glucose K = Potassium ALT = Alanine aminotransferase PTT = Partial Thromboplastin Time 8

11 Respiratory function Day 2 Time since reading taken Type of ventilation FiO2 s 36 hours Metabolic parameters Time since Source of sample (tick one box) ph pco 2 (kpa) po 2 (kpa) Base deficit (circle to show +ve or -ve) cap. 1 s art. ven / - 36 hours cap. art. ven / - Urine Output Urine output hours Urine output hours mls mls Comments: Continuing consent process: When did follow-up meeting with parents take place? 9

12 This period commenced on: Day 3 Time since Rectal temp ( o C) Cooling equipment/ Ambient temp ( o C) Cardiovascular parameters Heart rate (bpm) Mean BP (mmhg) Systolic BP (mmhg) Diastolic BP (mmhg) 48 hours 49 hours 50 hours 51 hours 52 hours 53 hours 54 hours 55 hours 56 hours 57 hours 58 hours 59 hours 60 hours hours 62 hours 63 hours 64 hours 65 hours 66 hours 67 hours 68 hours 69 hours 70 hours 71 hours

13 48 ISRCTN Day 3 Codes Drugs and Volume Ad = Adrenaline DM = Diamorphine Mz = Midazolam A = Albumin Dex = Dexamethasone P = Phenobarbitone replacement B = Whole Blood Db = Dobutamine PC = Packed Cells Please see measurement units CH= Chloral Hydrate D = Dopamine Pt = Phenytoin to be used and notes on page 19 C = Colloid L = Lignocaine S = Saline M = Morphine O = Other - Please specify in comment box overleaf Agent 1 Agent 2 Agent 3 Agent 4 Agent 5 Code Dose Code Dose Code Dose Code Dose Code Dose 71 NB: Day 3 continues overleaf 1 1

14 Day 3 Laboratory parameters - to be taken at 48 hours post (see codes below) Haematology Coagulation Hb (g/dl) Hct Total WBC Neut. count Platelets Ultrasound scan Ultrasound performed at 48 hours? Yes Time of scan (Please take an extra hard copy to return with the daily log.) ECG PT (seconds) PTT (seconds) Fibrinogen Was an ECG done in this 24hr period? Yes Biochemistry Na K Creat. Gluc. ALT (mmol/l) (mmol/l) (mmol/l) (mmol/l) (iu/l) If yes, was an arrhythmia present? Yes If yes, describe the arrhythmia: Positive Cultures: (Record positive cultures taken on this day.) Date and time sample collected Source e.g. blood, CSF Organism identified Codes Hb = Haemoglobin Hct = Haematocrit WBC = White Blood Count Neut. Count = Neutrophil Count PT = Prothrombin Time Creat.= Creatinine Na = Sodium Gluc. = Glucose K = Potassium ALT = Alanine aminotransferase PTT = Partial Thromboplastin Time 1 2

15 Respiratory function Day 3 Time since reading taken Type of ventilation FiO2 48 hours 60 hours Metabolic parameters Time since Source of sample (tick one box) ph pco 2 (kpa) po 2 (kpa) Base deficit (circle to show +ve or -ve) cap hours art. ven / - 60 hours cap. art. ven / - Urine Output Urine output hours Urine output hours mls mls Comments: 1 3

16 Day 4 This period commenced on: Time since Rectal temp ( o C) Cooling equipment/ Ambient temp ( o C) Cardiovascular parameters Heart rate (bpm) Mean BP (mmhg) Systolic BP (mmhg) Diastolic BP (mmhg) 72 hours 73 hour 74 hours 75 hours 76 hours 77 hours 78 hours 79 hours 80 hours If necessary, continue recordings below until normothermia is achieved 81 hours 82 hours 83 hours 84 hours 85 hours 86 hours Has an MRI been requested? (to be performed between 5-14 days of age, copy of report to be sent to Co-ordinating Centre please) Yes 1 4

17 Day 4 Codes Ad = Adrenaline DM = Diamorphine Mz = Midazolam A = Albumin Dex = Dexamethasone P = Phenobarbitone B = Whole Blood Db = Dobutamine PC = Packed Cells CH= Chloral Hydrate D = Dopamine Pt = Phenytoin C = Colloid L = Lignocaine S = Saline M = Morphine O = Other - Please specify in comment box overleaf Code Agent 1 Dose Drugs and Volume replacement Please see measurement units to be used and notes on page 19 Agent 2 Agent 3 Agent 4 Agent 5 Code Dose Code Dose Code Dose Code Dose If necessary, continue recordings below until normothermia is achieved NB: Day 4 continues overleaf 1 5

18 Day 4 Laboratory parameters - to be taken at 72 hours post (see codes below) Haematology Hb (g/dl) Hct Total WBC Neut. count Platelets Ultrasound scan Ultrasound performed at 72 hours? Yes Time of scan (Please take an extra hard copy to return with the daily log.) Coagulation ECG PT (seconds) PTT (seconds) Fibrinogen Was an ECG done in this 24hr period? Yes If yes, was arrhythmia present? Biochemistry Yes Na K Creat. Gluc. ALT (mmol/l) (mmol/l) (mmol/l) (mmol/l) (iu/l) If yes, describe the arrhythmia: Positive Cultures: (Record positive cultures taken on this day.) Date and time sample collected Source e.g. blood, CSF Organism identified Codes Hb = Haemoglobin Hct = Haematocrit WBC = White Blood Count Neut. Count = Neutrophil Count PT = Prothrombin Time Creat.= Creatinine Na = Sodium Gluc. = Glucose K = Potassium ALT = Alanine aminotransferase PTT = Partial Thromboplastin Time 1 6

19 Respiratory function Day 4 Time since reading taken Type of ventilation FiO2 72 hours 80 hours Metabolic parameters Time since Source of sample (tick one box) ph pco 2 (kpa) po 2 (kpa) Base deficit (circle to show +ve or -ve) cap hours art. ven / - 80 hours # cap. art. ven / - Urine Output # If sample available at this time Urine output hours mls Comments: Please turn to next page to complete Hypoxic Ischaemic Encephalopathy Score 1 7

20 Hypoxic Ischaemic Encephalopathy Score on Day 4 Please enter the appropriate number in the Score column for each sign. Sign Score Tone rmal Hyper Hypo Flaccid Level of rmal Hyper alert, stare Lethargic Comatose Consciousness Fits rmal Infrequent Frequent <3 /day >2/day Posture rmal Fisting, cycling Strong distal Decerebrate flexion Moro rmal Partial Absent Grasp rmal Poor Absent Suck rmal Poor Absent / bites Respiration rmal Hyperventilation Brief apnoea Apnoeic Fontanelle rmal Full, not tense Tense Form completed by: BLOCK CAPITALS PLEASE 1 8

21 Recording doses of medications administered. (Pages 3,7,11,and 15) Please record medications given during each hour as measured using the unit specified below for each item. Enter the number only in the box, after the appropriate code. For other medications please show clearly the units used. PLEASE WRITE CLEARLY Code and medication Ad = Adrenaline Dosage unit micrograms/kg/minute A = Albumin millilitres B = Whole Blood millilitres CH = Chloral Hydrate milligrams C = Colloid millilitres D = Dopamine micrograms/kg/minute Db = Dobutamine micrograms/kg/minute Dex = Dexamethasone DM = Diamorphine micrograms micrograms/kg/hour L = Lignocaine micrograms/kg/hour M = Morphine micrograms/kg/hour Mz = Midazolam micrograms/kg/hour P = Phenobarbitone milligrams PC = Packed Cells millilitres Pt = Phenytoin milligrams S = Saline millilitres O = Other as appropriate 1 9

22 Checklist: When returning the Daily Log please remember to include the following items: Photocopy or printout of CFM trace (at least the eligibility assessment trace, and any other available trace that was recorded during the first 80 hours after ) Hard copies of ultrasound scans When available please provide a copy of: US scan reports MRI scan report Death summary if applicable Please provide the baby NHS number as soon as possible PLEASE KEEP A PHOTOCOPY OF THIS COMPLETED BOOKLET FOR YOUR RECORDS 2 0

23 Day 1 NOTES FOR THE COMPLETION OF THIS BOOKLET Complete the information boxes on the front of the booklet and on page 1 then complete the remainder of the questions in order. Filinthestudynum Fill in number beroneverypage every (top right hand corner). Please make sure that ALL boxes have been completed. Please write clearly at all times. If codes and abbreviations are required, please follow the instructions provided. te: The time of is the time given by the telephone service, at. Ambient Temperature: Please record the environmental temperature that is appropriate if cooling equipment is not in use, i.e. overhead heater, incubator or room temperature. Drugs and Volume replacement: Please see the notes and units of measurement for the most commonly used medications on page 19. Please record the amount delivered to the baby during each hour, entering the number only unless the item is not included in the list on page 19. Please DO NOT use Greek symbols, if necessary please write mcg or ng for microgram and nanogram respectively. Volume replacement does not include maintenance fluids. Urine output: Please record urine output as accurately as possible within the constraints of the method being used. Positive Cultures: Please record results on the day the sample was taken, not on the day the results were received. Comments boxes: For information that you feel is relevant, but has not been specifically asked for elsewhere on the form. When all data have been collected and recorded, send the booklet and any additional items to the Trial Co-ordinator: TOBY Co-ordinating Centre National Perinatal Epidemiology Unit FREEPOST (OF 2279) Oxford OX3 7YN Many thanks for your help. 2 1

24 TOBY Clinical Co-ordinating Centre: Department of Paediatrics Faculty of Medicine Imperial College London Hammersmith Campus Du Cane Road London W12 0NN Tel: Fax: Data Co-ordinating Centre: TOBY Office National Perinatal Epidemiology Unit University of Oxford Old Road Campus Headington Oxford OX3 7LF Tel: /6 Fax: For URGENT queries outside office hours telephone and leave a message with the operator. You will be called back. Web: toby@npeu.ox.ac.uk