A phase-II clinical trial of targeted cerebral near infrared spectroscopy using standardized treatment guidelines to improve brain oxygenation in preterm infants (BOx-II): A study protocol.

BACKGROUND: Mortality and brain injury are common adverse outcomes in infants born <28 weeks. Conventional pulse oximetry may not detect subclinical changes prior to deterioration and fails to detect changes within the brain. Increasing evidence supports the use of cerebral near-infrared spectroscopy (NIRS) in the early care of preterm infants, yet the impact of specific interventions on cerebral oxygenation and the relationship between cerebral hypoxia and brain injury on MRI remain to be determined. METHODS/DESIGN: 100 infants <28 completed weeks of gestation will be recruited for a prospective, multicenter intervention trial. After informed consent, infants will undergo cerebral NIRS monitoring starting within 6 h of birth and continuing through 72 h. Infants with persistent cerebral desaturation will receive interventions following a standard treatment algorithm selected by the provider based on the patient's clinical condition. Providers will record the timing and choice of intervention(s) and term equivalent brain MRI will be performed for survivors. There are three objectives of this study: 1) to identify the relationship between cerebral hypoxia burden and brain injury on term-equivalent MRI. 2) to identify most common interventions after cerebral hypoxia, and 3) to quantify frequency of occult cerebral hypoxia events. DISCUSSION: There is increasing evidence for the role of early cerebral NIRS monitoring in the neuroprotective care of preterm infants. This phase-II trial will provide essential data to improve the intervention approach, model the effect size of interventions on a wider extent of brain injury, and quantify the discrepancy between measurements of systemic and cerebral hypoxia.

Evaluation of the minimum age for consent to mental health treatment with the minimum age of criminal responsibility in children and adolescents: a global comparison.

BACKGROUND: In many countries, a young person who seeks medical care is not authorised to consent to their own assessment and treatment, yet the same child can be tried for a criminal offence. The absence of child and adolescent mental health legislation in most countries exacerbates the issues young people face in independently accessing mental healthcare. Countries with existing legislation rarely define a minimum age for mental health consent (MAMHC). In stark contrast, nearly all 196 nations studied maintain legislation defining a minimum age of criminal responsibility (MACR). OBJECTIVE: This review highlights inconsistent developmental and legal perspectives in defined markers of competency across medical and judicial systems. METHODS: A review of the MAMHC was performed and compared with MACR for the 52 countries for which policy data could be identified through publicly available sources. FINDINGS: Only 18% of countries maintain identifiable mental health policies specific to children's mental health needs. Of those reviewed, only 11 nations maintained a defined MAMHC, with 7 of 11 having a MAMHC 2 years higher than the country's legislated MACR. CONCLUSIONS: With increasing scientific understanding of the influences on child and adolescent decision making, some investment in the evidence-base and reconciliation of the very different approaches to child and adolescent consent is needed. CLINICAL IMPLICATIONS: A more coherent approach to child and adolescent consent across disciplines could help improve the accessibility of services for young people and facilitate mental health professionals and services as well as criminal justice systems deliver optimal care.

How canola and sunflower oils affect lipid profile and anthropometric parameters of participants with dyslipidemia.

Background: Restricted intakes of saturated and trans-fatty acids and replacement with poly or monounsaturated fatty acids are emphasized in healthy diets. This study evaluates the effects of a six-month consumption of canola oil compared to sunflower oil on lipid profile and anthropometric parameters of people affected by dyslipidemia. Methods: This randomized controlled trial was conducted on 96 patients with dyslipidemia, who were randomly assigned into canola oil or the sunflower oil groups. The participants were instructed to record the contents of their daily meals, beverages, fruits, and snacks a day before treatment, at the second clinic visit, in the third month, and at the end of study (i.e., six months). Lipid profile and anthropometric parameters were compared between the two groups. Student t-test or Mann Whitney U test was used for statistical comparisons of variables between groups. Multivariate analysis was performed to adjust the confounding factor effects. Results: Of the enrolled participants, 44 (45.8%) were on sunflower oil diet and 52 (54.2%) on canola oil diet. We observed no change in anthropometric parameters and thus no significant difference between the two groups (p>0.05). Significant reductions in LDL-C (p<0.001), total cholesterol (p<0.001) and triglyceride levels (p<0.001), and significant elevation in HDL-C (p=0.008) were observed in canola oil group, as well as those who used sunflower oil. Conclusion: Dietary fats in the form of canola oil or sunflower oil effectively lower the serum cholesterol, LDL-C and triglyceride concentrations. They also result in an increase in serum concentration of HDL-C. These oils, however, did not modify general anthropometric parameters.