Breastfeeding in infants with tongue tie

Recruiting

Conditions: Other problems with newborn,

Registration Number: CTRI/2021/10/037312

Lead Sponsor: Swati Amol Manerkar

Brief Summary: 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) Oâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Lokmanya Tilak Municipal Medical College & General Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Lokmanya Tilak Municipal Medical College & General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Swati Amol Manerkar
Principal investigator
9769997968
drswatimanerkar@gmail.com