| No |
Summary |
Date |
Documents |
| 1 |
Addition of new sites. |
14/05/18 |
Amendment tool Approval |
| 2 |
Addition of new sites. |
14/06/18 |
Amendment tool Approval |
| 3 |
Addition of watermark to the RCT & Cohort consent form and changes to the format to the contact details section of Information leaflet. |
21/06/18 |
Amendment tool Approval |
| 4 |
Addition of new sites. |
23/07/18 |
Amendment tool Approval |
| 5 |
Addition of new sites. |
19/07/18 |
Amendment tool Approval |
| 6 |
Addition of new sites. |
14/08/18 |
Amendment tool Approval |
| 7 |
Addition of new sites. |
11/10/18 |
Amendment tool Approval |
| 8 |
Change of PI at North Tees and Hartlepool Hospitals NHS Foundation Trust. |
18/10/18 |
Approval |
| 9 |
Update to baseline questionnaire, Two Month Follow Up Questionnaire A, Two Month Follow Up Questionnaire B, Six Month Follow Up Questionnaire A & Six Month Follow Up Questionnaire B. |
30/10/18 |
Amendment tool Approval |
| 10 |
RCT & Cohort Consent form: Points 13 and 14 have been amended to state that the HES and ONS data will be accessed via the information and statistics division for Scotland rather than NHS digital. |
10/01/19 |
Amendment tool Approval |
| 11 |
Addition of new sites. |
17/01/19 |
Amendment tool Approval |
| 12 |
Updates to Baseline Questionnaire, Two Mont Follow-Up Questionnaires A & B, Six Month Follow-Up Questionnaires A & B. |
26/03/19 |
Amendment tool Approval |
| 13 |
Addition of new sites. |
28/03/19 |
Amendment tool Approval |
| 14 |
Update to Big Baby Trial Poster to be more eye catching to potential participants. |
18/04/19 |
Amendment tool Approval |
| 15 |
Addition of new sites. |
1/05/19 |
Amendment tool Approval |
| 16 |
Addition of new sites. |
21/06/19 |
Amendment tool Approval |
| 17 |
Addition of new sites. |
30/07/19 |
Amendment tool Approval |
| 18 |
Change of PI at Sherwood. |
24/10/19 |
Approval |
| 19 |
Addition of new sites. |
24/10/19 |
Amendment tool Approval |
| 20 |
Trust name change North Cumbria. |
08/11/19 |
Amendment tool Approval |
| 21 |
Addition of new sites. |
05/11/19 |
Amendment tool Approval |
| 22 |
Change of PI at Lancashire. |
18/11/19 |
Approval |
| 23 |
Change of PI at Imperial. |
17/12/19 |
Approval |
| 24 |
Change of PI at Birmingham. |
09/12/19 |
Approval |
| 25 |
Addition of new sites. |
20/01/20 |
Amendment tool Approval |
| 26 |
Change of PI at Ormskirk. |
31/03/20 |
Approval |
| 27 |
COVID-19 changes to working pattern and process of sending out follow up questionnaires – not implemented. |
02/04/20 |
Amendment tool Approval |
| 28 |
COVID-19 changes to working pattern and process of sending out follow up questionnaires. |
22/05/20 |
Amendment tool Approval |
| 29 |
Change of PI at Middlesex. |
16/06/20 |
Approval |
| 30 |
Change of PI at Sherwood. |
30/06/20 |
Approval |
| 31 |
Change of PI at UHCW. |
02/09/20 |
Approval |
| 32 |
Change of PI at East Lancashire. |
03/09/20 |
Approval |
| 33 |
Change of PI Burton. |
19/10/20 |
Approval |
| 34 |
Addition of updated documents to research clinician’s sub study documents. |
15/12/20 |
Amendment tool Approval |
| 35 |
Approval of translated documents (PIS and IC). |
11/12/20 |
Amendment tool Approval |
| 36 |
Change PI E Lancs. |
16/12/20 |
Approval |
| 37 |
Change PI Countess of Chester. |
16/02/21 |
Approval |
| 38 |
Change PI Pennine acute. |
11/05/21 |
Approval |
| 39 |
Change PI temp w. sussex. |
14/05/21 |
Approval |
| 40 |
Extension of recruitment timelines. |
24/05/21 |
Amendment tool Approval |
| 41 |
Change of PI Warwick. |
10/06/21 |
Approval |
| 42 |
Approval of translated documents (PIS). |
27/07/21 |
Amendment tool Approval |
| 43 |
Change in PI Ysbyty Gwynedd. |
17/08/21 |
Approval |
| 44 |
Temporary PI Burton. |
20/08/21 |
Approval |
| 45 |
Change in PI Countess of Chester |
20/11/21 |
Approval |
| 46 |
Addition of new site. |
18/03/22 |
Amendment tool Approval |
| 47 |
BB2Up sub study change to invitation email. |
26/04/22 |
Amendment tool Approval |
| 48 |
BB2Up sub study change to Participant information sheet GDPR wording. |
26/04/22 |
Amendment tool Approval |
| 49 |
Change in PI West Hertfordshire. |
03/05/22 |
Approval |
| 50 |
Translations PIS v9.0. |
06/05/22 |
Amendment tool Approval |
| 51 |
Addition of PI to Darlington Memorial Hospital. |
16/08/22 |
Approval |
| 52 |
Update of Study documents for Big Baby 2 up. |
04/11/22 |
Amendment tool Approval |
| 53 |
Update of Study documents for Big Baby 2 up. |
17/03/23 |
Amendment tool Approval |
| |
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| 55 |
Addition of thank you vouchers to Big Baby 2 Up |
05/07/23 |
Amendment tool Approval |
| 56 |
Addition of Big Baby 2 Up Voucher attachment |
31/08/23 |
Amendment tool Approval |
| 58 |
End Date - Big Baby 2 Up final data collection. Minor amendment to protocol - description of Big Baby 2 Up outcome measure. |
05/11/24 |
Amendment Tool HRA Email |
| End of Study |
Declaration of End of Study (07/05/2025) |
09/06/25 |
EoS Form |
