THE EFFECT OF ANKYLOGLOSIA ON BREASTFEEDING: A COHORT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Beastfeeding effectiveness
研究概览
简要总结
Ankyloglossia is a congenital condition characterized by a restrictive lingual frenulum that may limit normal tongue mobility and be associated with breastfeeding difficulties. Reported problems include ineffective latch, maternal nipple pain and nipple trauma, mastitis, reduced milk transfer, poor infant weight gain, and early breastfeeding cessation. However, the available evidence regarding the impact of ankyloglossia on breastfeeding outcomes remains limited and controversial.
The primary objective of this prospective cohort study is to evaluate the association between neonatal ankyloglossia, assessed using the TABBY assessment tool during the first 72 hours of life, and breastfeeding effectiveness measured using the LATCH scale during the same period.
Mother-infant dyads will be recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth, at the University Hospital of Guadalajara, Spain. Newborns will be classified according to the presence or absence of ankyloglossia using the TABBY assessment tool and will be followed for the first 6 months of life. Information will be collected during routine clinical follow-up and through telephone interviews.
The secondary objectives are to evaluate the association between ankyloglossia and breastfeeding duration, exclusive breastfeeding duration, maternal pain during breastfeeding, and maternal breastfeeding satisfaction.
详细描述
A prospective observational cohort study will be conducted. Mother-infant dyads will be recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara.
The presence of ankyloglossia will be assessed using the TABBY tool during the first 72 hours of life. Newborns will be classified into two cohorts according to the presence or absence of ankyloglossia. The planned sample size is 146 mother-infant dyads: 73 newborns with ankyloglossia and 73 newborns without ankyloglossia.
Non-probability consecutive sampling will be used. For each newborn with ankyloglossia included in the study, one newborn without ankyloglossia will be selected from among the next newborns assessed who meet the inclusion criteria and whose parents provide informed consent.
The study will not assign interventions or modify routine clinical care. The performance of frenotomy and the provision of individual breastfeeding counselling will depend on the clinical assessment and the decisions made by the healthcare professionals responsible for the participants' care. These procedures will be recorded to analyse their possible association with breastfeeding outcomes.
The initial assessment of ankyloglossia using TABBY and breastfeeding effectiveness using LATCH will be performed during the first 72 hours of life. The dyads will be followed up between 5 and 15 days, between 30 and 40 days, and at 4 and 6 months of life. Information will be obtained from clinical assessments, electronic health records and, when necessary, telephone interviews.
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
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother-infant dyads recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara.
- •Singleton pregnancy.
- •Gestational age at birth between 37 weeks and 41 weeks and 6 days.
- •Maternal intention to provide exclusive or mixed breastfeeding.
- •Written informed consent provided by the parent or legal guardian.
排除标准
- •Birth outside the University Hospital of Guadalajara.
- •Preterm birth (<37 weeks of gestation).
- •Fetal or neonatal pathology diagnosed before or after birth.
- •Admission to the neonatal unit after birth or during the hospital stay.
- •Any contraindication to breastfeeding.
- •Language barriers preventing communication in Spanish with the parents or legal guardians.
- •Withdrawal of informed consent.
- •Loss to follow-up.
研究组 & 干预措施
Newborn with ankyloglossia
干预措施: TABBY (Diagnostic Test)
Newborn without ankyloglossia
结局指标
主要结局
Beastfeeding effectiveness
时间窗: During the first 72 hours of life.
Breastfeeding effectiveness assessed using the LATCH scale. LATCH (Latch, Audible swallowing, Type of nipple, Comfort, Hold).Breastfeeding effectiveness will be assessed using the LATCH scale. The scale evaluates five components: latch, audible swallowing, type of nipple, maternal breast and nipple comfort, and positioning assistance. Each component is scored from 0 to 2, giving a total score from 0 to 10. Higher scores indicate more effective breastfeeding
次要结局
- Duration of exclusive breastfeeding assessed by maternal telephone interview(From birth to 6 months of age)
- Duration of any breastfeeding assessed by maternal telephone interview(From birth to 6 months of age)
- Maternal nipple pain assessed using the Numerical Rating Scale (NRS)(During the first 72 hours after birth and at 5-15 days)
- Breastfeeding outcomes after frenotomy assessed using the LATCH scale and maternal follow-up interviews(From birth through 6 months of age)
- Maternal satisfaction with breastfeeding assessed using a 0-to-5 numerical rating scale(From birth to 6 months of age)
研究者
Ariana Muñoz San Miguel
Associate Professor, Midwife, and PhD Candidate
University of Alcala