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临床试验/CTRI/2021/10/037312
CTRI/2021/10/037312招募中不适用

Breastfeeding outcomes of infants with tongue tie: An observational prospective cohort study

Swati Amol Manerkar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Study breastfeeding outcomes in babies with tongue tie with respect to exclusive breastfeeding at discharge/ 1 month/ 3 months and 6 months.

研究概览

简要总结

Introduction:

Ankyloglossia or tongue tie is the presence of an unusually short,thick or tight lingual frenulum tethering the tongue tip to the floor of themouth. (1) This may restrict normal tongue movements leading to difficulties inbreastfeeding in the early neonatal period. Breastfeeding difficulties reportedwith tongue-tie include poor latch, poor milk transfer, maternal nipple pain,milk supply issues and poor infant weight gain. The prevalence of tongue tievaries from 10-46% as per various studies.  Frenotomy is a commonly suggested interventionin cases with tongue tie. The impact of frenotomy on reduction in nipple painand increasing the ease of breastfeeding is known. Impact of frenotomy onimprovement in breastfeeding is debatable.(2)

Coryllos and colleagues described anterior (types 1 and 2) andposterior tongue-ties (types 3 and 4).(3) Haham et al. examined the incidenceof these types but did not find a difference in breastfeeding problems based ontype. (4) Ghaheri et al. found an improvement in breastfeeding after laserfrenotomy for anterior and posterior tongue-ties. (5) However, Douglasquestions the widespread diagnosis of posterior tongue-ties and discusses therole of other factors in impaired tongue function (e.g., infant musculoskeletaltensions and breastfeeding positioning). (6) O’Callahan et al. retrospectivelyexamined anterior and posterior tongue-ties; they found many infants withposterior ankyloglossia had persistent breastfeeding difficulties after initialanterior frenotomy. The breastfeeding issues improved only after the posteriorfrenotomy was performed. (7)

In our facility, we see several babies with tongue tie havingfeeding difficulties, poor latch and mothers complaining of breast and nipplepain. Very often these infants present with poor weight gain or excessiveweight loss after birth.  Some of themundergo a frenotomy in order to facilitate proper latching at the breast andbreastfeeding. The aim of this study was to study the breastfeeding outcomes ofinfants with tongue tie and determine if frenotomy improves breastfeedingoutcomes and decreases maternal nipple pain.

Keywords: ankyloglossia, breastfeeding difficulties, breast pain,LATCH assessment tool, tongue-tie

Aims and Objectives:

1.               To study prevalence of tongue tie in our birthcohort

2.               To study the clinical profile of infants with atongue-tie

3.               Identify types and grade the severity of tonguetie

4.               Study breastfeeding outcomes in babies withtongue tie with respect to exclusive breastfeeding at discharge/ 1 month/ 3months and 6 months.

5.               Study maternal perception of breastfeeding preand post frenotomy

Methods:

Design: A prospective cohort study design will be used.

Setting: PNC and NICU, LTMGH

Timeline: 3 years

Inclusion criteria:

All stable term and late preterm infants identified to have tonguetie on assessment.

Exclusion criteria:

Preterms < 34 weeks, Neurologically abnormal neonates, Neonateswith labial frenulum or other orofacial malformations

Methods: All mother infant dyads delivering/ admitted to thehospital will be provided lactation counselling by trained lactationcounsellors. Dyads with feeding difficulties/failure to thrive/maternal nipplepain will be identified and assessed. All these neonates will be screened fortongue tie with the use of TABBY (Tongue tie and breastfed babies) tongueassessment tool, which is a visual tool for assessment of tongue tie. Thisscreening will be done by trained lactation counsellors and confirmed by a certifiedlactation consultant.

TABBY:

The Tongue-tie and Breastfed Babies(TABBY) assessment tool consists of 12 images demonstratingappearance of the infant tongue, its attachment to the gum and the limitsof tongue mobility.

A score of 8 indicates normal tongue function. 6-7 borderline and 5or less suggests impaired tongue function.

Infants with borderline or impaired tongue function will be assessedfor any neurologic problems by a neonatologist. An oromotor evaluation will bedone by a neonatal therapist to look for oromotor dysfunction due to othercauses. Feeding issues due to oromotor dysfunction due to causes other thantongue tie will be addressed by providing appropriate oromotor stimulation.

Once tongue tie is ascertained to be a significant problem forfeeding difficulties by the clinical team, baby will be enrolled in the trialafter obtaining a written informed consent from the parents.

The clinical profile of mother and baby will be noted. Feedingproblems like poor latch, nipple pain, nipple injuries, low milk output, poorweight gain/excessive weight loss, low urine output etc will be assessed andrecorded. Nipple abnormalities and evidence of nipple trauma will be assessedand recorded.LATCH score (max 10 points) will be assessed andrecorded.

Nipple pain will be assessed on Likert scale of 1-10, 1 being nopain and 10 being maximum pain.

Coryllos ankyloglossia grading scale will be used to identifyanterior and posterior variants of tongue tie.

Motherswill receive breastfeeding support by counselling and practical help forpositioning and achieving a deep latch, prone feeding etc. Frenotomy Decisiontool for breastfeeding dyads (Carole Dobrich) will be used to decide eligibilityfor frenotomy by a certified lactation consultant. Ascore of >= 2 indicates need for frenotomy.

Once decision for frenotomy is taken, a written informed consentwill be obtained from the parents.  Thetiming of frenotomy will be recorded (day of life). Frenotomy will be conductedby a trained surgeon.

The LATCH score will be assessed before frenotomy, immediately afterfrenotomy and 2 days post frenotomy. Maternal nipple pain will be assessed by avisual/ analogue Likert scale pre and post frenotomy. Bleeding post frenotomywill be noted.

A neonatal therapist will objectively assess improvement in oromotorfunction 2 days post frenotomy (using Neonatal Oromotor Assessment Scale- NOMAS).

Babies will be followed up 7 days and 14 days post frenotomy, andLATCH score and pain score reassessed. Adequacy of exclusive breastfeeding willbe assessed by weight gain at 1 month post frenotomy, 3 months and 6 months ofage on exclusive breastfeeding. Need for supplementary feeding will berecorded, volume of supplementary feeds and reason for providing supplementaryfeeds will be noted.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All stable term and late preterm infants identified to have tongue tie on assessment.

排除标准

  • Preterms < 34 weeks, Neurologically abnormal neonates, Neonates with labial frenulum or other orofacial malformations.

结局指标

主要结局

Study breastfeeding outcomes in babies with tongue tie with respect to exclusive breastfeeding at discharge/ 1 month/ 3 months and 6 months.

时间窗: At discharge/ 1 month/ 3 months and 6 months.

次要结局

  • 1.To study prevalence of tongue tie in our birth cohort(During hospital stay)
  • 2.To study the clinical profile of infants with a tongue-tie(During hospital stay)
  • 3.Identify types and grade the severity of tongue tie(During hospital stay)
  • 5.Study maternal perception of breastfeeding pre and post frenotomy(During hospital stay)

研究者

发起方
Swati Amol Manerkar
申办方类型
Other [self]

研究点 (1)

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