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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

From: A hybrid type I, multi-center randomized controlled trial to study the implementation of a method for Sustained cord circulation And VEntilation (the SAVE-method) of late preterm and term neonates: a study protocol

  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