Achievability of recruitment rate. The number of participating centers was increased by new partners (university hospitals/ medical providers treating high patient numbers in specialized pediatric intensive care units). All centers have experience in adhering to scientific protocols and have participated in prospective studies. The necessary patient numbers (n=106) calculated by the power analysis will be achieved in the three year period according to patient numbers of the individual centers. The Hannover Medical School and University of Leipzig have participated in several (multi center) prospective studies without encountering problems with patient recruitment after proper counseling on study goals, protocols and the possible complications in relation to estimated benefits [11-25]. The recruitment of patients in this study will occur after enterostomy creation. As the patients should be clinically stable by this time, the parents will have enough time to make their decision on whether they want their infant to participate in the trial.
Appears in 2 contracts
Samples: Study Protocol, Study Protocol
Achievability of recruitment rate. The center number of participating centers was increased by new partners (university hospitals/ medical providers treating high patient numbers in specialized pediatric intensive care units). All centers have experience in adhering to scientific protocols and have participated in prospective studies. The necessary patient numbers (n=106) calculated by the power analysis will be achieved in the three year period according to patient numbers of the individual centers. The Hannover Medical School and University of Leipzig have participated in several (multi center) prospective studies without encountering problems with patient recruitment after proper counseling on study goals, protocols and the possible complications in relation to estimated benefits [11-25]. The recruitment of patients in this study will occur after enterostomy creation. As the patients should be clinically stable by this time, the parents will have enough time to make their decision on whether they want their infant to participate in the trial.
Appears in 1 contract
Samples: Study Protocol
Achievability of recruitment rate. The number of participating centers was increased by new partners (university hospitals/ medical providers treating high patient numbers in specialized pediatric intensive care units). All centers have experience in adhering to scientific protocols and have participated in prospective studies. The adapted necessary patient numbers number (n=106n=120) calculated by the power analysis will be achieved in the three a five year period according to patient numbers of the individual centers. The Hannover Medical School and University of Leipzig have participated in several (multi center) prospective studies without encountering problems with patient recruitment after proper counseling on study goals, protocols and the possible complications in relation to estimated benefits [11-25]. The recruitment of patients in this study will occur after enterostomy creation. As the patients should be clinically stable by this time, the parents will have enough time to make their decision on whether they want their infant to participate in the trial.
Appears in 1 contract
Samples: Study Protocol
Achievability of recruitment rate. β The center number of participating centers was increased by new partners (university hospitals/ medical providers treating high patient numbers in specialized pediatric intensive care units). All centers have experience in adhering to scientific protocols and have participated in prospective studies. The necessary patient numbers (n=106) calculated by the power analysis will be achieved in the three year period according to patient numbers of the individual centers. The Hannover Medical School and University of Leipzig have participated in several (multi center) prospective studies without encountering problems with patient recruitment after proper counseling on study goals, protocols and the possible complications in relation to estimated benefits [11-25]. The recruitment of patients in this study will occur after enterostomy creation. As the patients should be clinically stable by this time, the parents will have enough time to make their decision on whether they want their infant to participate in the trial.
Appears in 1 contract
Samples: Study Protocol