Neonatal ECMO Study of Temperature

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Neonatal ECMO Study of Temperature

• NEST

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

• 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

• 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

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

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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.

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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.

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Problems with randomisation?

• Telephone the randomisation service on 07623
  947508
• Please give ltYOUR NAMEgt, at ltYOUR HOSPITALgt, on
  ltYOUR FULL TELEPHONE NUMBERgt about NEST
• Wait 15 minutes
• If you have no response telephone [phone]

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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!

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Housekeeping!
Once you know the randomisation and study number

• Write the study number on the babys study
  documentation, copies of scans and reports etc.
• Stick a NEST notes label with completed study
  number on the outside of the babys hospital notes

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• 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.

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Complete Daily Progress Chart for 96 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!!
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ECMO Unit Discharge FormThis should be
completed when the baby

• is transferred to another hospital
• is discharged home
• dies

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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

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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.
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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

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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

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Thank you