Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial

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.

Is There a “Right” Amount of Oxygen for Preterm Infant Stabilization at Birth?

“…Those needing ≥ FiO 2 0.3 showed evidence of increased cerebral hypoxia (rsSO 2 <55%) but no difference in the degree of cerebral hyperoxia, suggesting that infants with SpO 2 may need more rapid upward FiO 2 titration to prevent cerebral hypoxia (73). The COSGOD III study aims to recruit 726 infants <32 weeks gestation to determine if cerebral NIRS measurements can influence the risk of survival and cerebral injury (74). Using rcSO 2 measurements as well as SpO 2 may serve to further inform on optimum oxygen needs for the transitioning preterm infant.…”

Cerebral Oximetry in Preterm Infants–To Use or Not to Use, That Is the Question

“…For cerebral oximetry, an attempt is currently in progress to obtain such evidence by a pragmatic randomized clinical trial, the SafeboosC-III trial (NCT03770741), enrolling 1,600 extremely preterm infants, to test the hypothesis that the risk of death or survival with severe brain injury can be reduced from 34 to 26.5% (19). Also, the COSGOD Phase III trial (Cerebral tissue oxygenation Saturation to Guide Oxygen Delivery, NCT 03166722) is underway, testing the benefit in the delivery suite (20).…”

Delivery Room Care for Premature Infants Born after Less than 25 Weeks’ Gestation—A Narrative Review

“…It remains uncertain whether this was due to insufficient oxygen administration or poor pulmonary function. Optimal oxygen saturation, optimal oxygen titration in the DR, and the use of near-infrared spectroscopy during the stabilization of premature infants born after <25 weeks' gestation needs further research with the aim to generate higher quality evidence adequately powered for neurodevelopmental outcomes [70,72].…”