Title: Neonatal ECMO Study of Temperature
1Neonatal ECMO Study of Temperature
Procedures
2Our aim an average of 4.4 recruits per
month 118 recruits by June 2008
3Baby needs ECMO
Born in other hospital
In born
Contact ECMO centre
Baby transferred to ECMO centre
Baby meets NEST eligibility criteria
4NEST 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
5Baby meets NEST eligibility criteria
Yes
No
Discuss NEST with parents
Baby receives standard ECMO care
Give parents study information leaflet
Obtain written consent
6NEST 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
7NEST 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.
8Randomisation
- 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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11Problems 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 07885 720537
12Remember!
- 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!
13Housekeeping!
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
14- 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.
15Complete 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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17 ECMO Unit Discharge FormThis should be
completed when the baby
- is transferred to another hospital
- is discharged home
- dies
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19If 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
20If 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.
21Final 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
22Keep 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
23Thank you