Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Nipple pain
研究概览
简要总结
A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine:
- the presence of continued problematic breastfeeding symptoms
- if further tongue tie or lip tie release improves those outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy babies who are breastfeeding
- •Had a previous frenotomy prior to presenting to the P.I.
排除标准
- •Twins, triplets
- •Maternal breast surgery or IGT
- •Premature birth
- •Significant heart/lung/brain disease of infant
研究组 & 干预措施
Intervention
干预措施: Lingual frenotomy and/or maxillary labial frenectomy (Procedure)
结局指标
主要结局
Nipple pain
时间窗: 1 week post-procedure
Reflux (i-GERQ-R)
时间窗: 1 week and 1 month post-procedure
Maternal breastfeeding self-efficacy (BSES-SF)
时间窗: 1 week and 1 month post-procedure
次要结局
未报告次要终点
研究者
Bobak Ghaheri, MD
Otolaryngologist/Head and Neck Surgeon
The Oregon Clinic