Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8,698
- 试验地点
- 6
- 主要终点
- The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn
研究概览
简要总结
At birth, the umbilical cord is cut, separating physically and symbolically the mother of his child. Before cord drop, umbilical area is a possible way of bacterial infection. Thus, umbilical cord infections constitute a major cause of neonatal morbidity and mortality in developing countries. In industrialized countries, omphalitis cases have almost disappeared whatever cord care strategies. At this day, care practices appear extremely different between countries, based more on habits and convictions that on evidence-based medicine. The investigators propose to conduct a non inferiority multicenter clustered crossed randomized study. Observations sessions will be performed on two consecutive periods of 5 months: 4 months of recruitment and 1 month follow-up. Main objective is to demonstrate that dry cord care practice would not expose to a higher risk of omphalitis than antiseptic based care approach. The purpose of NEOCORD study is a simplification of cord care for paramedical teams and parents, but also a significant reduction of costs in a medico-economic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn > 36 weeks of gestation.
- •Asymptomatic newborn hospitalization.
- •Information and consent of parental or legal authority.
排除标准
- •Family or social environment considered incompatible with dry cord care by investigator from a hygienic point of view (no fixed abode etc...).
- •Hospitalization in neonatal intensive care unit.
- •Transfer to another maternity hospital.
- •Gestational age less than or equal to 36 weeks of gestation.
- •Serious Congenital Pathology.
- •Opposition of parents.
结局指标
主要结局
The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn
时间窗: 13 months
The primary endpoint will correspond to the incidence of omphalitis occurred within 28 days post-birth. The omphalitis is defined as the presence of erythema or serous or purulent in-cord tissue or umbilical perished. The stages are described to investigators about watching information in a search for suspected omphalitis. This can be confirmed retrospectively by an Awards Committee composed of a Dermatopédiatre, a pediatrician and a pediatric surgeon.
次要结局
- Parental satisfaction(13 months)
- Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life(13 months)
- Date of the fall of the umbilical cord(13 months)
- State immunization against pertussis parental(13 months)
- Diet of the child at day 28.(13 months)
- Description of bacterial flora in umbilical waning of omphalitis(13 months)
- Occurrence of an infection or néonatlale maternal postpartum(13 months)
- Sleeping patterns of children in the first months of life(13 months)