Dataset Information

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: BACKGROUND:Transition 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/DESIGN:COSGOD 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. DISCUSSION:crSO2 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 REGISTRATION:ClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.

SUBMITTER: Pichler G

PROVIDER: S-EPMC6427901 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Pichler Gerhard G Baumgartner Sigrid S Biermayr Marlene M Dempsey Eugene E Fuchs Hans H Goos Tom G TG Lista Gianluca G Lorenz Laila L Karpinski Lukasz L Mitra Souvik S Kornhauser-Cerar Lilijana L Avian Alexander A Urlesberger Berndt B Schmölzer Georg M GM

Trials 20190320 1

<h4>Background</h4>Transition 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 surv ...[more]

PMID: 30894226

Similar Datasets

Project description:ObjectiveTo investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone.DesignMulticentre, multinational, randomised controlled phase 3 trial.Setting11 tertiary neonatal intensive care units in six countries in Europe and in Canada.Participants1121 pregnant women (<32 weeks' gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group.InterventionPreterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation.Main outcome measureThe primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge.ResultsCerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%) v control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70).ConclusionMonitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks' gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant.Trial registrationClinicalTrials.gov NCT03166722.

Project description:BACKGROUND:Short-acting vasopressor agents like phenylephrine or ephedrine can be used during carotid endarterectomy (CEA) to achieve adequate blood pressure (BP) to prevent periprocedural stroke by preserving the cerebral perfusion. Previous studies in healthy subjects showed that these vasopressors also affected the frontal lobe cerebral tissue oxygenation (rSO2) with a decrease after administration of phenylephrine. This decrease is unwarranted in patients with jeopardized cerebral perfusion, like CEA patients. The study aimed to evaluate the impact of both phenylephrine and ephedrine on the rSO2 during CEA. METHODS:In this double-blinded randomized controlled trial, 29 patients with symptomatic carotid artery stenosis underwent CEA under volatile general anesthesia in a tertiary referral medical center. Patients were preoperative allocated randomly (1:1) for receiving either phenylephrine (50 µg; n?=?14) or ephedrine (5 mg; n?=?15) in case intraoperative hypotension occurred, defined as a decreased mean arterial pressure (MAP)???20% compared to (awake) baseline. Intraoperative MAP was measured by an intra-arterial cannula placed in the radial artery. After administration, the MAP, cardiac output (CO), heart rate (HR), stroke volume, and rSO2 both ipsilateral and contralateral were measured. The timeframe for data analysis was 120 s before, until 600 s after administration. RESULTS:Both phenylephrine (70?±?9 to 101?±?22 mmHg; p?<?0.001; mean?±?SD) and ephedrine (75?±?11 mmHg to 122?±?22 mmHg; p?<?0.001) adequately restored MAP. After administration, HR did not change significantly over time, and CO increased 19% for both phenylephrine and ephedrine. rSO2 ipsilateral and contralateral did not change significantly after administration at 300 and 600 s for either phenylephrine or ephedrine (phenylephrine 73%, 73%, 73% and 73%, 73%, 74%; ephedrine 72%, 73%, 73% and 75%, 74%, 74%). CONCLUSIONS:Within this randomized prospective study, MAP correction by either phenylephrine or ephedrine showed to be equally effective in maintaining rSO2 in patients who underwent CEA. Clinical Trial Registration ClincalTrials.gov, NCT01451294.

Project description:BackgroundArterial hypoxemia occurs in about 2.5-69% of cases during fiberoptic bronchoscopy and may necessitate administration of supplemental oxygen. Whether routine supplementary administration is indicated for all patients is a debated issue. In this prospective randomized study, we assessed the incidence of systemic desaturation (SpO2 <90% or a >4% decrease lasting for more than 60 s) and wanted to find out whether cerebral desaturation occurs in parallel with systemic changes.Patients and methods92 consecutive patients scheduled for diagnostic bronchoscopy were randomly assigned to the no oxygen (O2- group), 2 l/min supplemental O2, or 4 l/min supplemental O2 groups. Primary end points were systemic and cerebral desaturation rate during the procedure. Secondary end points were to delineate the main risk factors of systemic and cerebral desaturation.ResultsIn the entire cohort, systemic desaturation occurred in 18.5% of patients (n = 17), corresponding to 5 patients (16%) in the O2 (-)group, 6 patients (19%) in the 2 l/min group, and 6 patients (20%) in 4 l/min group, respectively. In the O2 (-) group, the probability of desaturation was 41.7 times higher than that in the 2 l/min group (p=0.014 s), while there was no difference in the probabilities of desaturation between the 2 l/min and 4 l/min groups (p=0.22). Cerebral desaturation (more than 20% rSO2 decrease compared to baseline) did not occur in any patients in the three groups. Systemic desaturation developed earlier, and recovery after desaturation was longer in the O2 (-) group. Male gender, smoking, and systemic oxygen saturation at baseline and FEV1% were the most significant factors contributing to systemic desaturation during bronchoscopy.ConclusionsAdministration of supplemental oxygen does not prevent systemic desaturation during flexible bronchoscopy, but may contribute to the shortening of desaturation episodes and faster normalization of oxygen saturation. According to our results, 2 l/min supplemental oxygen should routinely be administered to patients throughout the procedure. This trial is registered with NCT04002609.

Project description:Background Perioperative neurocognitive disorders (PND) is a common postoperative complication including postoperative delirium (POD), postoperative cognitive decline (POCD) or delayed neurocognitive recovery. It is still controversial whether the use of intraoperative cerebral function monitoring can decrease the incidence of PND. The purpose of this study was to evaluate the effects of different cerebral function monitoring (electroencephalography (EEG) and regional cerebral oxygen saturation (rSO2) monitoring) on PND based on the data from randomized controlled trials (RCTs). Methods The electronic databases of Ovid MEDLINE, PubMed, EMBASE, Cochrane Library database were systematically searched using the indicated keywords from their inception to April 2020. The odds ratio (OR) or mean difference (MD) with 95% confidence interval (CI) were employed to analyze the data. Heterogeneity across analyzed studies was assessed with chi-square test and I2 test. Results Twenty two RCTs with 6356 patients were included in the final analysis. Data from 12 studies including 4976 patients were analyzed to assess the association between the EEG-guided anesthesia and PND. The results showed that EEG-guided anesthesia could reduce the incidence of POD in patients undergoing non-cardiac surgery (OR: 0.73; 95% CI: 0.57–0.95; P?=?0.02), but had no effect on patients undergoing cardiac surgery (OR: 0.44; 95% CI: 0.05–3.54; P?=?0.44). The use of intraoperative EEG monitoring reduced the incidence of POCD up to 3?months after the surgery (OR: 0.69; 95% CI: 0.49–0.96; P?=?0.03), but the incidence of early POCD remained unaffected (OR: 0.61; 95% CI: 0.35–1.07; P?=?0.09). The remaining 10 studies compared the effect of rSO2 monitoring to routine care in a total of 1380 participants on the incidence of PND. The results indicated that intraoperative monitoring of rSO2 could reduce the incidence of POCD (OR 0.53, 95% CI 0.39–0.73; P?<?0.0001), whereas no significant difference was found regarding the incidence of POD (OR: 0.74; 95% CI: 0.48–1.14; P?=?0.17). Conclusions The findings in the present study indicated that intraoperative use of EEG or/and rSO2 monitor could decrease the risk of PND. Trial registration PROSPREO registration number: CRD42019130512.

Dataset Information

Publications

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets