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Neonatal ECMO Study of Temperature

Neonatal ECMO Study of Temperature. NEST. Procedures. Our aim: an average of 4.4 recruits per month 118 recruits by June 2008. Baby needs ECMO. Born in other hospital. In born. Contact ECMO centre. Baby transferred to ECMO centre. Baby meets NEST eligibility criteria. NEST Document Box.

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Neonatal ECMO Study of Temperature

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  1. Neonatal ECMO Study of Temperature NEST Procedures

  2. Our aim: an average of 4.4 recruits per month 118 recruits by June 2008

  3. Baby needs ECMO Born in other hospital In born Contact ECMO centre Baby transferred to ECMO centre Baby meets NEST eligibility criteria

  4. NEST Document Box • Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSARS) form • Change of Address card • FREEPOST envelopes • Hospital notes labels • Going Home Leaflet - M/F • Bereavement Leaflet • Baby Pack • Going Home Pack • Transfer Pack • Replacement Document order form • Contact Information • Flow Chart • Study Protocol • Summary Protocol • Handbook for ECMO Centre • Handbook for Transfer Centre • Parent Information Leaflet - (Male/Female) • Further Information Leaflet-M/F • Consent Form • Entry Form • Daily Progress Form • ECMO Unit Discharge Form • Discharge Form

  5. Baby meets NEST eligibility criteria Yes No Discuss NEST with parents Baby receives standard ECMO care Give parents study information leaflet Obtain written consent

  6. NEST Eligibility Criteria 1 Inclusion criteria Babies recruited to the study must meet the existing standard criteria for ECMO eligibility. These include: • at least 35 weeks gestation • at least 2000g weight • no uncontrolled bleeding disorder • no congenital or acquired CNS disorder • no more than 7 consecutive days of high pressure ventilation prior to referral for ECMO • the underlying condition is potentially reversible • evidence of severe cardio-respiratory failure • less than 29 days of age

  7. NEST Eligibility Criteria 2 Exclusion criteria • All neonates referred with diaphragmatic hernia. • All neonates receiving ECMO for post operative cardiac support. All other infants will be eligible unless aspects of their medical condition prevent or render them inappropriate for ECMO.

  8. Randomisation Complete Q 1-8 on the study entry form before going to the randomisation web page at: https://rct.npeu.ox.ac.uk/nest Follow the on screen instructions.

  9. Problems with randomisation? • Telephone the randomisation service on: 07623 947508 • Please give <YOUR NAME>, at <YOUR HOSPITAL>, on <YOUR FULL TELEPHONENUMBER> about NEST • Wait 15 minutes • If you have no response telephone: 07885 720537

  10. Remember! If you need to telephone PLEASE • Include full dialling code with the telephone number • DO NOT give the number of the busiest desk phone on the unit – it may well be engaged when Sarah tries to call you back!

  11. Housekeeping! Once you know the randomisation and study number: • Write the study number on the baby’s study documentation, copies of scans and reports etc. • Stick a NEST notes label with completed study number on the outside of the baby’s hospital notes

  12. Complete the remainder of the study entry form, photocopy it and post it to the NEST Co-ordinating office at NPEU. For both cooled and control babies give parents the “Further Information Leaflet” during ensuing discussions.

  13. Complete Daily Progress Chart for96 hours following randomisation and post it to NPEU.Write CLEARLYComplete all fields or explain absence of data NB: Blank boxes or unclear answerswill be returned to you for clarification!!

  14. ECMO Unit Discharge FormThis should be completed when the baby: • is transferred to another hospital • is discharged home • dies

  15. If a baby dies or is discharged home • If a baby dies you may wish to give parents the Bereavement Leaflet • If a baby is discharged home please give parents the Going Home Pack

  16. If a baby is transferring to another hospital Complete the identifiers on the Discharge Form and send it with a Transfer Pack with the baby to the receiving hospital.

  17. Final Checklist For each recruit we want to receive: Copy of consent form Completed Entry form Progress form ECMO Unit discharge form Discharge form if applicable CFM trace MRI images USS images

  18. Keep photocopies!! • Other studies have experienced loss of data in the post, it could happen to you! • Keep photocopies of all completed forms a) for your own records, you may undergo a local audit or inspection for exampleb) to save you starting again from scratch if the originals do go astray

  19. Thank you

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