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: