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临床试验/CTRI/2026/01/102074
CTRI/2026/01/102074尚未招募不适用

Association Between Lingual Frenum Attachment and Breastfeeding Difficulties in Infants Using Clinical Assessment Tools: A Cross-Sectional Observational Study.

Uttaranchal Dental and Medical Research Institute1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
Bristol Tongue Assessment Tool (BTAT)

研究概览

简要总结

Introduction

Ankyloglossia, also known as tongue-tie, is a condition that impairs tongue movement due to a restrictive lingual frenulum. The presence of a tongue-tie (ankyloglossia) in an infant may lead to breastfeeding difficulties.1 The incidence of tongue-tie ranges from 3% to 16% worldwide and the presence of a tongue-tie in an infant may lead to breastfeeding difficulties. This wide range of prevalence is partly because of the lack of a single definition and the differences among investigators.2 Anterior ankyloglossia is classic ankyloglossia, where the frenulum attaches at or close to the tongue tip, limiting tongue mobility.  Diagnosis of posterior ankyloglossia remains a subject of controversy. Posterior ankyloglossia occurs when the frenulum attaches to the posterior aspect of the ventral surface of the tongue and restricts tongue mobility. Some also use the term to refer to the submucosal tethering of the tongue. Others consider posterior ankyloglossia normal frenulum attachment and attribute breastfeeding difficulties to other factors, like nipple anatomy, maternal milk production, and maternal experience.2 Maxillary lip frenulum tethering has also been reported to affect breastfeeding. Ingram et al. in 2015 developed the Bristol Tongue Assessment Tool (BTAT).3 The Bristol Tongue Assessment Tool provides an objective, clear and simple evaluation of the severity of the tongue-tie.4 Whilst the importance of breastfeeding is widely recognised, supporting it can be challenging. the Infant Breastfeeding Assessment Tool (the IBFAT) to assess and measure infant breastfeeding competence. It was designed for use by mothers, midwives and other health professionals.5

Frenotomy for ankyloglossia has increased nearly 10-fold over the past few decades despite insufficient evidence that the procedure improves breastfeeding outcomes. There is no universally accepted method for identifying patients who may benefit from the procedure.6 The objective of this observational study is to determine the association between classification of lingual frenum using BTAT and assess breastfeeding difficulties using IBFAT.

Null hypothesis:

There is no association between the different levels of lingual frenum attachment with experience of difficulty in breast feeding.

Aim and objectives:

The aim of the study is to assess the correlation between the level of lingual frenum attachment with difficulty in breast feeding in infants

The objectives of the study are-

1.     To assess the level of lingual frenum attachment in infants using the Bristol Tongue Assessment Tool (BTAT).

2.     To evaluate breastfeeding difficulties using the Infant Breastfeeding Assessment Tool (IBFAT).

3.     To determine the correlation between BTAT scores and IBFAT scores, identifying the impact of lingual frenum attachment on breastfeeding success.

Inclusion criteria:

1.     Infants aged 0–6 months.

2.     Breastfeeding infants with or without feeding challenges.

3.     Lactating mothers willing to participate and provide informed consent.

Exclusion Criteria:

1.     Infants with congenital oral or craniofacial anomalies unrelated to the lingual frenum.

2.     Exclusively bottle-fed infants.

3.     Infants with prior surgical correction of ankyloglossia.

1. Assessment of Lingual Frenum Attachment

  • Tool: Bristol Tongue Assessment Tool (BTAT)

1.     Tongue tip appearance-

a.      Heart shaped- 0

b.     Slight cleft/notched- 1

c.      Rounded-2

2.     Attachment to the lower gum ridge-

a.      Attached at top of gum ridge- 0

b.     Attached to inner aspect of gum- 1

c.      Attached to floor of mouth- 2

3.     The lift of the tongue is seen when the infant is awake and is viewed when the infant is crying.

a.      Minimal tongue lift- 0

b.     Edges only to mid-mouth- 1

c.      Full tongue lift to mid-mouth- 2

4.     Protrusion of the tongue.

a.      Tip stays behind gum- 0

b.     Tip over gum- 1

c.      Tip can extend over lower lip- 2

The scores for the four items are summed and can range from 0 to 8. Scores of 0–3 indicate more severe reduction of tongue function.

2. Breastfeeding Evaluation

  • Tool: Infant Breastfeeding Assessment Tool (IBFAT)

1.     Readiness to feed or arousability. The observer is asked to record whether,

a.       the baby started to feed readily without effort (score 3),

b.     needed mild stimulation to start to feed (score 2),

c.      needed more vigorous stimulation to rouse and start to feed (score 1) or

d.     if the baby could not be roused (score 0).

2.     Rooting. This is defined in the standard way as ’At the touch of the nipple to the baby’s cheek, the head turns towards the nipple, the mouth opens and baby attempts to fix the mouth on the nipple’. The observer then recorded whether the baby,

a.      when placed beside the breast, rooted effectively at once (score 3),

b.     needed some coaxing, prompting, or encouragement to root (score 2),

c.      rooted poorly, even with coaxing (score 1)

d.     did not try to root (score 0)

3.     Fixing. The observer recorded the length of time, from placing the baby at the breast, that it took for the baby to ’latch on’ and start to feed well.

a.      Did he or she start to feed at once (score 3),

b.     take 3 to 10 minutes (score 2),

c.      take over 10 minutes (score 1) or

d.     did not feed (score 0)

4.     Sucking pattern. The observer was asked to choose the phrase which best described the baby’s feeding pattern at the feed.

a.      This ranged from ’baby did not suck’ (score 0),

b.     through ’sucked poorly’ (i.e., weak sucking, some sucking efforts for short periods) (score 1),

c.      ’sucked fairly well’ (sucked off and on, but needed encouragement) (score 2), or

d.     ’sucked well on one or both breasts’ (score 3).

3. Data Collection

·        Maternal Input:

o   History of breastfeeding difficulties (e.g., nipple pain, poor latch).

o   Perceived breastfeeding satisfaction.

·        Clinical Examination:

o   BTAT performed during routine oral examination.

·        Questionnaire Administration:

o   IBFAT scores completed during a feeding session with assistance from clinicians.

4. Data Analysis

·        Descriptive statistics for demographic and clinical data.

·        Correlation analysis (Pearson or Spearman coefficient) to assess the relationship between BTAT and IBFAT scores.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 6.00 Month(s)(—)
性别
All

入选标准

  • Infants aged upto 6 months.
  • Breastfeeding infants with or without feeding challenges.
  • Lactating mothers willing to participate and provide informed consent.

排除标准

  • Infants with congenital oral or craniofacial anomalies unrelated to the lingual frenum.
  • Exclusively bottle-fed infants.
  • Infants with prior surgical correction of ankyloglossia
  • Infants diagnosed with cretinism.

结局指标

主要结局

Bristol Tongue Assessment Tool (BTAT)

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

1. Tongue tip appearance-

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

a. Heart shaped- 0

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

b. Slight cleft/notched- 1

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

c. Rounded-2

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

2. Attachment to the lower gum ridge-

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

a. Attached at top of gum ridge- 0

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

b. Attached to inner aspect of gum- 1

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

c. Attached to floor of mouth- 2

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

3. The lift of the tongue is seen when the infant is awake and is viewed when the infant is crying.

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

a. Minimal tongue lift- 0

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

b. Edges only to mid-mouth- 1

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

c. Full tongue lift to mid-mouth- 2

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

4. Protrusion of the tongue.

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

a. Tip stays behind gum- 0

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

b. Tip over gum- 1

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

c. Tip can extend over lower lip- 2

时间窗: observation made one time after the enrollment of the infant to the study. Time taken is upto 10 min

次要结局

未报告次要终点

研究者

发起方
Uttaranchal Dental and Medical Research Institute
申办方类型
Other [Private Dental College]
责任方
Principal Investigator
主要研究者

Dr Preeti Pandey

Uttaranchal Dental and Medical Research Institute

研究点 (1)

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