Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Proportion of exclusively breastfeeding mothers
研究概览
简要总结
The investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia.
详细描述
The investigators plan to include a total 316 infants. The study will be carried out in level III hospital in Warsaw, Poland. The primary outcome will be exclusive breastfeeding at 12 weeks of age. Secondary outcomes include breastfeeding > 50% of feedings, improved breastfeeding comfort as assessed by the mother, weight gain, head circumference and length gain, the need to use a breast pump or lactation accessories, time of breastfeeding cessation, the type of lactation, neurological and rehabilitation assistance received, the frequency of obtained lactation, neurological and rehabilitation assistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •full - term infants born with an Apgar score of 8-10 points
- •no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)
- •parental consent
排除标准
- •low birth weight
- •perinatal complications
- •congenital craniofacial defects
- •neurological diseases
- •visible genetic syndromes
- •mother' unwilling to breastfeed
- •no consent for vaccination against hepatitis B
- •neonates born to HIV seropositive mothers
结局指标
主要结局
Proportion of exclusively breastfeeding mothers
时间窗: at 12 weeks of age
Proportion of exclusively breastfeeding mothers
次要结局
- Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.(at 12 weeks of age)
- Weight change(at 12 weeks of age)
- Head circumference change(at 12 weeks of age)
- Length change(at 12 weeks of age)
- Change in breastfeeding comfort(at 12 weeks of age)
- Time of breastfeeding cessation(during 12 weeks of age)
- Incidence of using a breast pump or lactation accessories(at 12 weeks of age)
- Rate of additional consultations(during 12 weeks of age)