RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial

Table 1 Activity scheme

	Screening	Enrolment	Intervention	End of intervention	Short-term endpoint assessment	Mid-term endpoint assessment	Long-term endpoint assessment
Date	x	x	x	x	x
Informed consent document	x
Signed informed consent document		x
Eligibility	x
Demographic and perinatal data		x
Parental data		x
NICU facilities		x
FICare profile		x
Day of life and PMA		x		x	x	x	x
Neonatal outcomes					x
Task on training			x	x
Kangaroo (hours/week)			x
Weight, length, head circumference		x	x	x	x	x	x
Nutrition				x	x	x
Maturation skills				x	x
Adverse events			x	x	x
Reason for early discontinuation				x
General health						x	x
Neurodevelopment							x
Economic impact^a			x	x	x		x
Parental questionnaires		x			x	x
Staff questionnaires^b

X indicates mandatory procedures that should be entered into the eCRF
NICU neonatal intensive care unit, FICare Family Integrated Care, PMA postmenstrual age
^aEconomic impact on newborns, carers and staff as described in Additional file 1
^b2 measurement points: first time before FICare implementation at his/her institution; second time at least 3 months after FICare implementation at his/her institution. In FICare expert centre only one time

ISSN: 1745-6215