RESUMO
OBJECTIVE: To determine rates of death or neurodevelopmental impairment (NDI) at 2 years corrected age (primary outcome) in children <32 weeks' gestation randomized to initial resuscitation with a fraction of inspired oxygen (FiO2) value of 0.21 or 1.0. STUDY DESIGN: Blinded assessments were conducted at 2-3 years corrected age with the Bayley Scales of Infant and Toddler Development, Third Edition or the Ages and Stages Questionnaire by intention to treat. RESULTS: Of the 290 children enrolled, 40 could not be contacted and 10 failed to attend appointments. Among the 240 children for whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died. The primary outcome, which was available in 238 (82%) of those randomized, occurred in 47 of the 117 (40%) children assigned to initial FiO2 0.21 and in 38 of the 121 (31%) assigned to initial FiO2 1.0 (OR, 1.47; 95% CI, 0.86-2.5; P = .16). No difference in NDI was found in 215 survivors randomized to FiO2 0.21 vs 1.0 (OR, 1.26; 95% CI, 0.70-2.28; P = .11). In post hoc exploratory analyses in the whole cohort, children with a 5-minute blood oxygen saturation (SpO2) <80% were more likely to die or to have NDI (OR, 1.85; 95% CI, 1.07-3.2; P = .03). CONCLUSIONS: Initial resuscitation of infants <32 weeks' gestation with initial FiO2 0.21 had no significant effect on death or NDI compared with initial FiO2 1.0. Further evaluation of optimum initial FiO2, including SpO2 targeting, in a large randomized controlled trial is needed. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Network Registry ACTRN 12610001059055 and the National Malaysian Research Registry NMRR-07-685-957.
Assuntos
Recém-Nascido Prematuro , Transtornos do Neurodesenvolvimento/epidemiologia , Oxigenoterapia/métodos , Oxigênio/administração & dosagem , Ressuscitação , Testes de Aptidão , Pré-Escolar , Feminino , Seguimentos , Idade Gestacional , Humanos , Recém-Nascido , Masculino , Oxigênio/sangueRESUMO
This study aimed to systematically assess the readiness of five countries - Brazil, the Former Yugoslav Republic of Macedonia, Malaysia, Saudi Arabia, and South Africa - to implement evidence-based child maltreatment prevention programs on a large scale. To this end, it applied a recently developed method called Readiness Assessment for the Prevention of Child Maltreatment based on two parallel 100-item instruments. The first measures the knowledge, attitudes, and beliefs concerning child maltreatment prevention of key informants; the second, completed by child maltreatment prevention experts using all available data in the country, produces a more objective assessment readiness. The instruments cover all of the main aspects of readiness including, for instance, availability of scientific data on the problem, legislation and policies, will to address the problem, and material resources. Key informant scores ranged from 31.2 (Brazil) to 45.8/100 (the Former Yugoslav Republic of Macedonia) and expert scores, from 35.2 (Brazil) to 56/100 (Malaysia). Major gaps identified in almost all countries included a lack of professionals with the skills, knowledge, and expertise to implement evidence-based child maltreatment programs and of institutions to train them; inadequate funding, infrastructure, and equipment; extreme rarity of outcome evaluations of prevention programs; and lack of national prevalence surveys of child maltreatment. In sum, the five countries are in a low to moderate state of readiness to implement evidence-based child maltreatment prevention programs on a large scale. Such an assessment of readiness - the first of its kind - allows gaps to be identified and then addressed to increase the likelihood of program success.