Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years of Age.

Erasme University Hospital1 个研究点分布在 1 个国家目标入组 348 人开始时间: 2022年5月23日最近更新: 2026年4月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 348
试验地点: 1
主要终点: Breastfeeding duration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The diagnosis of ankyloglossia (restrictive lingual frenulum) and the number of frenotomies in infants have sharply increased, raising concerns among the medical community and the ONE. While some studies suggest benefits of frenotomy on breastfeeding, all emphasize the lack of consensus regarding the definition, diagnosis, and classification of ankyloglossia, as well as the scarcity of prospective data on its impact on breastfeeding, feeding, occlusion, and speech.

This prospective study aims to determine whether lingual frenulum characteristics influence early breastfeeding difficulties and duration, as well as later feeding, occlusion, and speech outcomes. Breastfed newborns are followed from the first days of life (T1) to age 4 years (T7). During the first 3 months, tongue mobility, frenulum characteristics, breastfeeding, maternal pain, and complications are assessed. Several clinical tools are compared to identify the most reliable ones. Frenulum length is measured using calibrated photographs.

Phone follow-ups at 6 months, 1 and 2 years assess feeding outcomes; speech and occlusion are evaluated at 4 years.

This project could provide objective data to guide clinicians in evaluating ankyloglossia and making informed frenotomy decisions, improve breastfeeding support, and help parents make evidence-based choices.

详细描述

Design: Prospective longitudinal study. The study was approved by the Ethics Committee of Erasme Hospital on May 4, 2022 (Reference : P2022/167/B4062021000404).

Newborns and their mother are recruited at Maternity Ward of Erasme Hospital, HUB Belgium. The dyads are then been followed up to the age of 4 years through clinical examinations, questionnaires and phone calls. Assessments at 6 weeks and 3 months of age are conducted to analyze early outcomes.

Sample size:

Sample size was calculated as follows, based on the calculation of Souza-Oliveira et al.20 : we considered 4.8% incidence of ankyloglossia in newborns based on the study by Messner et al. (2000), a margin of error of 3.0%, and 99.0% of confidence interval. The minimum sample size was 337. From 2022 to 2024, we have already completed our sample recruiting 348 in order to compensate for possible losses in the follow-up.

Primary outcomes: pain during breastfeeding (VAS and Mc Gill Pain Questionary), breastfeeding duration (days), presence of crackled nipples, engorgement, mastitis, nipple bleeding, abscess (breastfeeding complications).

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 1 Day 至 5 Days（Child）
性别: All
接受健康志愿者: 是

入选标准

•Newborn infant with a gestational age ≥ 37 weeks admitted to the postnatal ward of Hospital Erasmus- 1 to 5 days old
•Mother intends to breastfeed at the postnatal ward
•At least one parent has a good understanding of French

排除标准

•Newborns will be excluded from the study if they present any of the following:
•Severe medical conditions, including congenital oropharyngeal malformations (e.g. cleft lip, heart defects or brain anomalies) or Prader-Willi syndrome, sepsis, intrauterine growth restriction, need for intensive care
•A positive COVID-19 test (for either the newborn or parents)
•Multiple births (twins, triplets)
•Parents under psychosocial surveillance

研究组 & 干预措施

Breastfeeding mothers

干预措施: LATCH score (Other)