Table 3 Questions or concerns regarding the trial as such
Who raised the concern? | Subject | Consequence or solution |
|---|---|---|
Consultant | In case of not be allowed to include the baby in the trial, are we allowed to use the data collected until that time? | None |
Family | What will happen if there is no agreement in the trial participation between two parents? | We decided that participation will be only considered when two parents agree in the participation. We included this issue in the verbal information to the families. |
Grandparent | Concern about the safety of NIRS. | Give the parents a detailed interpretation about the NIRS monitoring |
Mother | In case of giving permission to use the data of my baby, the data used for the study could identify my baby? | We gave a detailed explanation regarding the protection of personal data. We explained to the parents that the personal data of the baby won’t be included in the database. Only clinical data will be used. |
Nurse | Nurse’s point of view was that the explanation in the CI was extremely technical. In their opinion, it was too technical and it needed to be explained more simplified with more algorithms. | We modified the CI by adding more pictures explaining NIRS and also explaining the timing. Moreover, we made a PowerPoint presentation which was available in all the computers for all the staff to check all the information about the study. |
Parent | Will it harm the baby? | None |
Parent | Is there a cost involved for the use of the machine? | None |
Staff member | Will be any kind of data used if the consent form was declined by the family? | We asked to the principal investigator when this query was raised. They confirmed to us that any kind of data will be used when the family decline the participation in the trial. |
Resident | About clinical staff, the concern was the time of randomisation. Some preterm infants admitted to the hospital beyond 6 h of birth had no chance to take part in the trial. | It is a bit difficult for us to control it. |