The Committee requested the following changes to the Participant Information Sheet and Consent Form: The Committee requested that the Participant Information Sheet be reconsidered to improve the readability for lay participants. The Committee requested that the language in the Participant Information Sheet be reconsidered, for example to reword ‘Methods and Demands on Participants’ on the first page. Please ensure accurate compensation wording regarding ACC is included in the Participant Information Sheet. The Committee suggested the wording from the HDEC template: “If you were injured in this study, which is unlikely, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover” For completeness please provide a copy of the Consent Form. Decision This application was provisionally approved by consensus, subject to the following information received. Please make changes to the Participant Information detailed in points 16-19 above. Please provide a copy of the Consent Form and the Māori Consultation response for completeness. This following information will be reviewed, and a final decision made on the application, by Secretariat. 2 Ethics ref: 15/NTA/152 Title: PADDOCK Principal Investigator: Dr Humphrey, W, H Pullon Sponsor: CNS - Clinical Network Services Ltd Clock Start Date: 01 October 2015 Dr Humphrey Pullon and a representative from the Study Sponsor were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study trial
Please make the minor changes to the Participant Information Sheet detailed in points 18 and 19 above. 7 Ethics ref: 15/NTA/146 Title: The ABC 'Assisted breathing before cord clamping' Principal Investigator: Mrs Elizabeth Nevill Sponsor: Counties Manukau Health Clock Start Date: 01 October 2015 Mrs Elizabeth Nevill and Mike were present in person for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The study investigates whether delayed cord clamping (DCC) and breathing assistance can improve the short and long term outcomes for preterm infants. An observational audit of records showed that preterm (<31 week gestation) infants who did not establish regular respirations during DCC had worse outcomes than those that did breathe. Theoretically, provision of breathing support during DCC may facilitate optimal PTF, reduce the need for RBC transfusion and result in a more stable neonatal transitional circulation. Preterm infants born<31 week gestation will be recruited over an estimated 3 year period. Infants will be randomized to receive standard treatment (position, thermal wrap) or breathing support in addition to standard treatment during 50 sec delayed cord clamping. Infants will remain in the study until discharge from hospital. Infants who are apnoeic or do not have sustained breathing effort will be randomised to either receive the planned intervention or standard practice. (Infants that have sustained spontaneous breathing effort at birth and during DCC will not be randomised to receive the intervention and, will not the study). Eligible infants that receive DCC will be randomised at 15 sec of age once the breathing has been assessed. The intervention (study group) consists of positive pressure ventilation (PPV) or continuous positive airway pressure (CPAP) commencing at 20sec of age and continuing for a further 30sec (infants will therefore receive 50sec of DCC). Delayed cord clamping is standard care in some hospitals. The outcomes recorded in this study include whether the infants need a transfusion or develop chronic lung disease, defined as needing help to breathe at 36 weeks or being discharged with oxygen for home use. A data safety monitoring committee will be elected to review serious outcomes every 6 months. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows.