Abstract
BackgroundTransition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia–ischemia may cause perinatal brain injury.The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO2) using specified clinical treatment guidelines during the immediate transition period after birth (the first 15 min) in addition to the routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR).Methods/DesignCOSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these.The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO2, SpO2, and HR readings are visible, and the infant will receive treatment in accordance with defined treatment guidelines. In the control group, only SpO2 and HR will be visible, and the infant will receive routine treatment. The intervention period will last for the first 15 min after birth during the immediate transition period and resuscitation. Thereafter, each neonate will be followed up for primary outcome to term date or discharge. The primary outcome is mortality or cerebral injury (or both) defined as any intra-ventricular bleeding or cystic periventricular leukomalacia (or both). Secondary outcomes are neonatal morbidities.DiscussioncrSO2 monitoring during immediate transition has been proven to be feasible and improve cerebral oxygenation during immediate transition. The additional monitoring of crSO2 with dedicated interventions may improve outcome of preterm neonates as evidenced by increased survival without cerebral injury.Trial registrationClinicalTrials.gov Identifier: NCT03166722. Registered March 5, 2017.
Highlights
Transition immediately after birth is a complex physiological process
In a two-center prospective observational case control study, we demonstrated that neonates developing an intra-ventricular hemorrhage (IVH) during the first week after birth showed lower Cerebral tissue oxygen saturation (crSO2) values already during immediate transition compared with neonates without IVH [22]
Trial objectives Based on the findings in the observational studies and COSGOD phase I/II trial, the objective of the present clinical trial is to monitor crSO2 using near-infrared spectroscopy (NIRS) INVOS 5100 (Medtronic, Minneapolis, MN, USA) in addition to routine monitoring of Arterial oxygen saturation (SpO2) and heart rate (HR) to guide supplemental oxygen delivery and respiratory/circulatory support in preterm neonates during the first 15 min after birth
Summary
The transition from the intra-uterine to extra-uterine environment is a complex physiological process characterized by major physiological changes in respiratory and hemodynamic functions, which are predominantly initiated by breathing at birth and clamping of the umbilical cord [1]. Two-center prospective observational case control study, we demonstrated that neonates developing an intra-ventricular hemorrhage (IVH) during the first week after birth showed lower crSO2 values already during immediate transition compared with neonates without IVH [22]. In an NIRS-visible group, crSO2 monitoring in addition to routine monitoring with pulse oximetry and ECG was used to guide respiratory and supplemental oxygen support during the first 15 min after birth. Trial objectives Based on the findings in the observational studies and COSGOD phase I/II trial, the objective of the present clinical trial is to monitor crSO2 using NIRS INVOS 5100 (Medtronic, Minneapolis, MN, USA) in addition to routine monitoring of SpO2 and HR to guide supplemental oxygen delivery and respiratory/circulatory support in preterm neonates during the first 15 min after birth. SpO2/HR monitoring during the first 15 min after birth will increase survival without cerebral injury and reduce morbidities in preterm neonates of less than 32 weeks of gestation
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