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 Study Resources

FEED1 database access

FEED1 randomisation system

FEED1 Macro database

Protocol

• FEED1 Protocol (Version 2.3, 13 Apr 2023)

Statistical Analysis Plan

• FEED1 Statistical Analysis Plan Final (Version 2.0, 03 Feb 2025)

Patient facing study documents

• FEED1 PIS (Version 3.1, 02 Mar 2023)
• FEED1 Short Information Flyer (Version 1.0, 02 July 2019)
• FEED1 Trial ICF (Version 1.3, 06 Jan 2022)
• FEED1 ThankYou Letter (Version 1.2, 17 Nov 2022) 

Please ensure the Participant Information Sheet and Short Information Flyer are localised with your Trust's information before providing to patients.

Archived Documents:

• FEED1 Protocol (Version 2.2, 02 Mar 2023)
• FEED1 Participant Information Sheet Final (Version 1.2, 07 Oct 2019)
• FEED1 Participant Information Sheet Final (Version 2.0, 14 May 2020) 
• FEED1 Participant Information Sheet Final (Version 3.0, 01 Dec 2021)
• FEED1 Protocol (Final Version 1.2 Date: 03 Sept 2019)
• FEED1 Protocol (Final Version 1.3 Date 14 May 2020)
• FEED1 Protocol (Version 1.4 Date: 17 Jun 2021)
• FEED1 Protocol (Version 2.0, 01 Dec 2021) 
• FEED1 Protocol (Version 2.1, 31 Oct 2022)
• FEED1 SAE Reporting form (Final Version 1.1, Date: 21 Oct 2019)
• FEED1 Trial ICF (Final Version 1.2, 23 Feb 2021)
  
• FEED1 ThankYou Letter (Version 1.1 28 May 2021)
• FEED1 CRF Workbook (Version 1.3, 06 Jan 2022) 
• FEED1 Patient Transfer Pack (Final Version 1.0, Date 03 Oct 2019

Case Report Forms (CRFs)

• FEED1 CRF Workbook (Version 1.5 14 Nov 2022) 
• FEED1 Infant Eligibility Checklist (Final Version 1.2, Date: 26 Nov 2019)
• FEED1 CRF Daily data (Final Version 1.0, Date: 19 Sep 2019)
• FEED1 CRF Gut signs (Final Version 1.0, Date: 19 Sep 2019)
• FEED1 CRF LOI (Final Version 1.1, Date: 12 Mar 2020)
• FEED1 Patient Transfer Pack (Final Version 3.0, Date: 16 Nov 2022)

Study Documents

• FEED1 SAE Reporting Form (Final Version 1.3, 06 Jan 2022) 
• FEED1 SAE Reporting flowchart (Final Version 1.1, Date: 14 April 2023)
• FEED1 File Note Template

Welsh Resources

• FEED1 Poster - Welsh Version
• FEED1 Participant Information Sheet Final Version 3.0 01 Dec 2021 WELSH
• FEED1 Short Information flyer Version 1.0 02 July 2019 WELSH
• FEED1 Informed Consent Form Version 1.3 06 Jan 2022 WELSH

   Archived Documents

• FEED1 Informed Consent Form Version 1.2 23 Feb 2021 WELSH
• FEED1 Participant Information Sheet Final Version 2.0 14 May 2020 WELSH

Database Instructions

• FEED1 Instructions Randomisation Database (Version 1.1, 18 Feb 2022)
• FEED1 Instructions MACRO (Version 1.1, 06 May 2020)
• Cessation in Trial Activities Training

Registration 

The FEED1 trial is registered on the public registry ISCRTN: ISRCTN89654042

Publications

• 'Delivering site set-up training to groups of sites versus individually: a randomised study within a trial'
• Implementing two-stage consent pathway in neonatal trial
• The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30-33 weeks gestational age)

Investigator meeting

• FEED1 Two year follow up
• FEED1 Adherence and managing conditions 
• FEED1 Improving follow up rates
• FEED1 Recruitment and eligibility