Evaluation of the Effects of Tongue-Tie and Upper Lip-Tie on Breastfeeding With Ultrasound Measurements and the LATCH Breastfeeding Assessment Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Distance between the nipple (N) and the hard-soft palate junction
研究概览
简要总结
Background: Tongue-tie and upper-lip tie have been linked to breastfeeding difficulties; however, the traditional evaluation tools that provide this information rely primarily on subjective assessments. In this context, ultrasound imaging has enabled an objective assessment of the sucking dynamics of infants. The aim of this study was to assess the impact of tongue-tie and upper lip-tie on sucking function in newborns via ultrasonography and other tools.
Methods: This prospective cohort study included 67 newborns (25 with tongue-tie, 21 with upper lip-tie, and 21 control) as well as their mothers. The maxillary labial frenulum was evaluated according to Kotlow, and the lingual frenulum was evaluated according to the Tongue Tie and Breastfed Infants (TABBY) tool. Sucking functions were examined via ultrasonography between postnatal days 5 and 15. Breastfeeding was evaluated via the LATCH tool, and maternal nipple pain was graded via a numerical rating scale. Mothers were interviewed by telephone about their breastfeeding continuity in the 1st month after birth. The data were analyzed through descriptive and inferential statistics and association tests.
详细描述
- Sample characteristics and study design:
This prospective cohort study was conducted at Ankara Yıldırım Beyazit University Faculty of Medicine, Internal Medicine Sciences, Department of Child Health and Diseases, Neonatology Clinic, from May 2022 to December 2022. The study included newborns with tongue-tie, newborns with upper lip-tie, and newborns without both. Written informed consent was obtained from all participating mothers, and the study was approved by the Clinical Research Ethics Committee of Ankara Yıldırım Beyazit University Faculty of Medicine (date and number: 30.03.2022 /26379996/06).
The inclusion criteria were breastfed newborns born within the last 48 hours, with a gestational age of 38 weeks or more, uncomplicated delivery, and no systemic problems, craniofacial anomalies, or birth defects. The exclusion criteria included premature or low birth weight newborns; those with delivery complications; intensive care unit admissions; systemic problems; craniofacial anomalies; birth defects; both tongue-tie and upper lip-tie; and those exclusively formula-fed.
As there was no comparable study that could be consulted to determine the sample size in the literature, a total of 60 neonates were recruited, with 20 in each group: tongue-tie (group 1), upper lip-tie (group 2), and control (group 3). 2. Data collection:
Data on maternal age, medical conditions, pregnancy medication, consanguineous marriage, number of births, breastfeeding experience, and breastfeeding education were collected via face-to-face interviews. Gestational week, sex, birth weight and mode of delivery were obtained from the birth records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Breastfed newborns born within the last 48 hours
- •Gestational age of 38 weeks or more
- •Uncomplicated delivery
- •Absence of systemic problems, craniofacial anomalies, or birth defects.
排除标准
- •Premature or low birth weight newborns
- •Newborns with delivery complications
- •Newborns admitted to the intensive care unit
- •Any systemic problems, craniofacial anomalies, birth defects
- •Presence of both tongue-tie and upper lip-tie
- •Newborns exclusively formula-fed.
结局指标
主要结局
Distance between the nipple (N) and the hard-soft palate junction
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the distance between the nipple (N) and the hard-soft palate junction (HSPJ) was measured via ultrasound imaging.
Intraoral space dept
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the intraoral space dept (the distance from the HSPJ to the surface of the mid-tongue) was measured via ultrasound imaging.
Nipple diameter (ND) at 2 mm from the tip of the nipple.
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 2 mm from the tip of the nipple was measured via ultrasound imaging.
Nipple diameter (ND) at 5 mm from the tip of the nipple.
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 5 mm from the tip of the nipple was measured via ultrasound imaging.
Nipple diameter (ND) at 10 mm from the tip of the nipple.
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 10 mm from the tip of the nipple was measured via ultrasound imaging.
Nipple diameter (ND) at 15 mm from the tip of the nipple.
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 15 mm from the tip of the nipple was measured via ultrasound imaging.
Anterior-tongue height
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the anterior-tongue height (the distance between the dorsal surface of the anterior-tongue and the inferior border of the genioglossus muscle) was measured via ultrasound imaging.
Mid-tongue height
时间窗: Between the 5th and 15th days after birth.
During sucking, while the tongue is positioned both upward and downward, the mid-tongue height (the distance between the dorsal surface of the mid-tongue and the inferior border of the genioglossus muscle) was measured via ultrasound imaging.
LATCH scores
时间窗: Between the 5th and 15th days after birth (at the ultrasound appointment)
Breastfeeding was assessed via the LATCH tool. This tool consists of 5 items that score latch, audible swallowing, type of nipple, comfort, and hold (positioning). Each item is evaluated on a scale of 0-2 points. The highest possible total score that can be obtained from the LATCH assessment tool is 10. A high score indicates greater success in breastfeeding.
Maternal nipple pain
时间窗: Between the 5th and 15th days after birth (at the ultrasound appointment) and the 1st month after birth (questioned at a telephone interview).
Maternal nipple pain was graded via a numerical rating scale. A score of 0 indicated "absence of pain," and a score of 10 indicated "presence of unbearable pain".
次要结局
未报告次要终点