Merali, Hasan S.
Tessaro, Mark O.
Ali, Khushboo Q.
Morris, Shaun K.
Soofi, Sajid B.
Ariff, Shabina
Funding for this research was provided by:
Grand Challenges Canada (R-ST-POC-1707-06658)
Article History
Received: 25 June 2019
Accepted: 12 September 2019
First Online: 13 November 2019
Ethics approval and consent to participate
: This study received approval from the Research Ethics Board at Sickkids Hospital (REB#: 1000057021) and the AKUH Ethical Review Committee (ERC#:4927-Ped-ERC-17) and the National Bioethics Committee of Pakistan (4–87/NBC-319/18/552). Any amendments to the study protocol will be submitted to both hospital committees for approval.In phase I of this study, all healthcare providers will provide written informed consent prior to participating in the study. For phase II of the study two separate protocols have been established for the use of ultrasound during intubations. Given the time-critical nature of emergency intubation, we will not be able to complete informed consent for research participation with families of these newborns. Therefore, we will utilize a deferred consent procedure and have ensured our study satisfies TCPS-2 Article 3.7 A for deferred consent. We will obtain written informed consent from parents after intubation and stabilization of the newborn. While not as time-critical as emergency intubations, semi-elective intubation can proceed rapidly and be associated with stressful timing for parents. These circumstances may interfere with the ability to provide informed consent at the time of a semi-elective intubations, so families will be approached for written informed consent at the time of admission to the NICU. Given that the data collected in the POCUS intervention does not change standard of care practices, a data monitoring committee is not needed for this study.
: Not applicable.
: The authors declare that they have no competing interests.