Lingual Frenulum in Newborn Infants (LINNE): Prospective, Observational Study of the Oral Structural Variations, Their Correlations to the Functional Distinctions, and a Randomized, Controlled Trial on the Treatment of the Tongue-tie
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Successful breastfeeding
研究概览
简要总结
Oral cavity's structural variations are involved in the successful breastfeeding of the newborn infants. The tongue-tie has been shown to cause breastfeeding problems. This project investigates the oral structural properties of the newborn infants and the efficacy and safety of their treatment options in breastfeeding problems. The project includes two studies: 1. A prospective follow-up study that investigates the epidemiology and associations between oral structures and breastfeeding problems in term and preterm infants; 2. A randomised, controlled study that investigates the efficacy and safety of tongue-tie treatments. Follow-up visits are planned two to three months, one year, and five years after randomisation along with a 6 months' e-questionnaire for all study patients. The study provides information at the population level.
详细描述
Part 3 of the LINNE project: Efficacy and safety of neonatal tongue-tie therapies: a controlled, randomised, clinical trial
1 Aim, hypotheses and objectives
Present trial investigates the effectiveness and safety of conservative and surgical treatments of tongue-tie in treatment of neonatal feeding difficulties. The neonatal participants have been diagnosed an anatomical and functional tongue-tie that interferes feeding in the observational study (Project parts 1-2).
Hypotheses
- A tongue-tie release procedure, frenotomy, indicated by the study tongue-tie criteria, is effective and safe
- The mother's breastfeeding experience and the parents' satisfaction improve with adequate treatment of the newborn
- No long-term adverse effects will be detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
One month follow-up time (parents unaware)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infant with at tongue-tie interfering the breastfeeding and patient's study screening scoring exceeding >8/19
排除标准
- •Child's severe anomaly or illness; the parent's severe illness; a communication problem between parents and researchers (e.g. language barrier); any other practical reason that prevents the child to have the procedure or the parents to provide the oral physiotherapy
研究组 & 干预措施
Frenotomy
Patients who will have frenotomy soon after randomisation, on the same or next day
干预措施: Frenotomy (Procedure)
Oral physiotherapy
Patients whose parents are guided to give the child oral physiotherapy for 1 month
干预措施: Oral physiotherapy (Procedure)
Follow-up
Patients whose frenotomy appointment will be set at 1 month age
结局指标
主要结局
Successful breastfeeding
时间窗: 1 month age
Mother breastfeeding the child w/o problems
次要结局
- Width of the jaw(1 month)
- Anatomical classification of the frenulum lingualis(1 month)
- Infant's height growth(1 year)
- Histological classification of the frenulum lingualis(1 month)
- Infant's head growth(1 year)
- Complications of the possible procedures(1 month)
- Breastfeeding problems questionnaire(1 month)
- Infant's morbidities(6 months)
- Breastfeeding problems' reasons(1 month)
- Duration of breastfeeding(6 months)
- Daily crying time of the infant(24 h)
- Infant's weight growth(1 year)
- Maternal breastfeeding experience, questionnaire(6 months)
- Parents' satisfaction, questionnaire(6 months)
- Height of the oral cavity(1 month)