Table 4.

The iceberg model of the organizational culture with study outcomes and data sources defined. The SAVE-method illustrating the practice and the implementation strategy and context illustrating the underlying determinants enabling the implementation of the SAVE-method

	Questions	Outcomes	Data sources
SAVE-method (Intact cord resuscitation)	Is the SAVE-method clinically effective for the neonate?	Cardiovascular stability and recovery after asphyxia Neurodevelopment after resuscitation Attachment/Bonding patterns after resuscitation (for complete list of clinical outcomes see www.clinicaltrials.gov)	Analysis of clinical routine data Postnatal surveys (ASQ) with parents at 4 and 12 months of age Analysis of clinical data from examination of psycho-motor development at 2 and 5.5 years of age Postnatal surveys on: breastfeeding (BSES) at 2, 4 and 6 months of age parental bonding at 2 and 6 months of age
	How do parents experience the SAVE-method?	Acceptability	Postnatal surveys with parents after birth Individual interviews (qualitative study III and IV)
	What are the attitudes and beliefs regarding cord clamping among different professionals present in the resuscitation situation?	Acceptability	Surveys with staff
	What is current cord-clamping practice in standard care?	Acceptability, Adoption	Surveys with midwives and obstetricians
	What are the experiences of ICR among staff in the labor- and neonatal units?	Acceptability	Implementation surveys with staff Individual interviews (qualitative study I and II)
	Is the SAVE-method applied by staff?	Adoption	Implementation surveys with staff
	What are the barriers and facilitators for using the SAVE-method?	Adoption	Implementation surveys with staff
Implementation strategies	Is staff participating in training incentives?	Fidelity of implementation strategy	Implementation surveys with staff
	Is the SAVE-method applied by staff?	Fidelity of the intervention (the SAVE-method)	Analysis of recruitment rate and cord clamping time registered for infants requiring resuscitation
	Is staff adhering to the study protocol?	Fidelity of the intervention (the SAVE-method)	Risk-based monitoring of study database
	Is staff comfortable with the training provided and instructions received?	Fidelity of implementation strategy	Implementation surveys with staff
Context	How is the organizational readiness level?	Acceptability	Surveys with staff
	How are resource levels?	Acceptability	Surveys with managers in the labor and neonatal unit
	How are the health service level?	Safety, effectiveness, timeliness, and equity	Analysis of adverse events, cord clamping time and socio-demographics of participants
	Equipment/setting/room	Acceptability	Surveys with managers in the labor and neonatal unit