I’m having problems randomising

If you have completed the online randomisation form:

  1. Login to the randomisation site
  2. Select ‘Recruitment List’
  3. If the randomisation has been successful, you can select ‘print’ to issue a pdf of the randomisation form and allocation

If the randomisation doesn’t appear in the ‘Recruitment List’, or you are unable to access the randomisation website for any other reason please contact the trial office on 01865 289278, or 0800 138 5451 for out-of-hours assistance

Is my patient eligible?

Please check the inclusion/exclusion criteria:

Inclusion Criteria

  • Parent(s) willing and able to give informed consent
  • Infants of corrected gestational age from 27+0 weeks to 44+0 weeks, AND working weight of 1,000 g or more
  • First LP for current indication

Exclusion Criteria

  • Unable to be held in sitting position (including infants intubated and mechanically-ventilated) or other clinical condition which is likely, in the opinion of the treating clinician, to make sitting difficult, or which is likely to be compromised by sitting (e.g. open gastroschisis).
  • Previously randomised to the trial
Who can take consent?

Clinicians must have an up-to-date GCP certificate and be approved on the Delegation Log to take informed consent from parents of eligible participants.

How do I enter <1 on OpenClinica lab results?

OpenClinica won’t let you enter symbols in the lab results sections, so for results <1, please enter 0.

What should I do with completed parent questionnaires?

The parent questionnaire is no longer being collected following completion of the pilot phase. Any completed questionnaires should be sent to the NeoCLEAR co-ordinating centre using freepost envelopes provided in your document box. Outstanding data entry onto OpenClinica will be completed at NPEU.

Updated: Thursday, 11 July 2019 11:12 (v10)