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Clinical Research Protocol Study Title: A randomized controlled trial of respiratory function monitoring during stabilization of preterm infants at birth Short Title: MONITOR Trial NCT Number: NCT03256578 Document IRB Approval Date: February 14, 2019 MONITOR TRIAL (Monitoring Neonatal Resuscitation Trial) A multi-center randomized controlled trial of respiratory function monitoring during stabilization of preterm infants at birth Local Principal Investigator (1) Elizabeth Foglia MD MSCE1 Division of Neonatology 3400 Spruce St. Ravdin 8 215-662-3228 [email protected] Coordinating Site Principal Investigator (2) Arjan te Pas2 C.Omar Kamlin3 Prof Maximo Vento4 Gianluca Lista5 Kajsa Bohlin7 Co-Investigators (3) Henriette van Zanten2 Prof Colin Morley3 Enrico Lopriore2 Prof Peter G Davis3 Marta Thio3 Charles Christopher Röhr2 Marta Aguar4 Francesco Cavigioli5 Erik van Zwet6 1. Hospital of the University of Pennsylvania, Philadelphia, United States 2. Leiden University Medical Center, Leiden, the Netherlands 3. Department of Newborn Research, Royal Women’s Hospital, Melbourne, Australia 4. Maternal & Children’s University Hospital La Fe, Valencia, Spain 5. Neonatal Intensive Care Unit, V.Buzzi Children's Hospital, Milan, Italy 6. Department of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands 7. Karolinska University Hospital Huddinge, Stockholm, Sweden Protocol Version: UPenn MONITOR Protocol Version 3.0 February 5, 2019 IRB Number: 826695 Coordinating Site Protocol Version: Protocol 12.295 v5 December 8, 2017 Netherlands Trial Registry: NTR4104 Clinicaltrials.gov Identifier: NCT03256578 Table of Contents LIST OF ABBREVIATIONS ................................................................................................................................. IV STUDY SUMMARY ........................................................................................................................................... 1 ........................................................................................................... 2 1. BACKGROUND AND STUDY RATIONALE .................................................................................................................................. 2 1.1 INTRODUCTION ................................................................................................. 2 1.2 BACKGROUND AND RELEVANT LITERATURE ................................................................................................ 3 1.3 RESPIRATORY FUNCTION MONITOR (RFM) ................................................................................................... 3 1.4 PRELIMINARY CLINICAL STUDIES OF RFM .................................................................................................................................. 4 2. STUDY OBJECTIVES ............................................................................................................................ 4 2.1 PRIMARY OBJECTIVE ....................................................................................................................... 4 2.2 SECONDARY OBJECTIVES ............................................................................................................................ 4 3. INVESTIGATIONAL PLAN ................................................................................................................................ 4 3.1 GENERAL DESIGN .............................................................................................................................. 5 3.2 SCREENING PHASE ................................................................................................................. 5 3.3 STUDY INTERVENTION PHASE .................................................................................................. 5 3.3.1 ALLOCATION TO INTERVENTIONAL GROUP ............................................................................................................................ 6 3.4 PRIMARY ENDPOINT ....................................................................................................................... 6 3.5 SECONDARY ENDPOINTS ..................................................................................... 7 4. STUDY POPULATION AND DURATION OF PARTICIPATION ............................................................................................................................ 7 4.1 INCLUSION CRITERIA ............................................................................................................................ 7 4.2 EXCLUSION CRITERIA ........................................................................................................................ 7 4.3 SUBJECT RECRUITMENT ................................................................................................................. 7 4.4 DURATION OF PARTICIPATION .................................................................................................... 8 4.5 TOTAL NUMBER OF SUBJECTS AND SITES .................................................................................................................. 8 4.6 VULNERABLE POPULATIONS: ............................................................................................................................... 8 5. STUDY INTERVENTION ..................................................................................................................................... 8 5.1 DESCRIPTION ..................................................................................................... 8 5.2 SUBJECT ENCOUNTER: DELIVERY ROOM ......................................................................................................................................... 9 5.3 TRAINING ......................................................................................................................................... 9 5.4 BLINDING ............................................................................................................... 9 5.5 TECHNIQUE OF RESUSCITATION ........................................................................................................ 9 5.6 DISCONTINUATION OF MONITORING .............................................................................................................................. 10 6. STUDY PROCEDURES ..................................................................................................................................... 10 6.1 SCREENING ............................................................................................................... 10 6.2 STUDY INTERVENTION PHASE ................................................................................................................... 10 6.3 DATA COLLECTION PHASE ...................................................................................................................... 10 6.4 SUBJECT WITHDRAWAL ........................................................................................................................ 11 6.5 SAFETY EVALUATIONS ................................................................................................................................. 11 7. STATISTICAL PLAN ................................................................................................................................ 11 7.1 BASELINE DATA ................................................................................................... 11 7.2 PRIMARY AND SECONDARY OUTCOMES .............................................................................................. 11 7.3 SAMPLE SIZE AND POWER DETERMINATION .................................................................................................................. 12 8. SAFETY AND ADVERSE EVENTS ................................................................................................................................... 12 8.1 DEFINITIONS CONFIDENTIAL ii This material is the property of the University of Pennsylvania. ............................................................................................................................... 12 8.1.1 ADVERSE EVENT .................................................................................................................... 12 8.1.2 SERIOUS ADVERSE EVENT .......................................................................................................... 13 8.2 RECORDING OF ADVERSE EVENTS ............................................................................................................ 13 8.3 RELATIONSHIP OF AE TO STUDY ................................. 14 8.4 REPORTING OF ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND UNANTICIPATED PROBLEMS .......................................................................................................................... 14 8.4.1 FOLLOW-UP REPORT ................................................................................. 14 8.4.2 INVESTIGATOR REPORTING: NOTIFYING THE PENN IRB .................................................................................................... 14 8.5 DATA AND SAFETY MONITORING PLAN ..................................................................... 15 9. STUDY ADMINISTRATION, DATA HANDLING, AND RECORD KEEPING .............................................................................................................................. 15 9.1 CONFIDENTIALITY ..................................................................... 16 9.2 DATA AND DEVICE COLLECTION, STORAGE, AND MANAGEMENT ......................................................................................................................
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