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CTRI Number  CTRI/2021/10/037312 [Registered on: 13/10/2021] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Breastfeeding in infants with tongue tie 
Scientific Title of Study   Breastfeeding outcomes of infants with tongue tie: An observational prospective cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Amol Manerkar 
Designation  Additional Professor 
Affiliation  Lokmanya Tilak Municipal Medical College & General Hospital 
Address  Department of Neonatology Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone    
Fax    
Email  drswatimanerkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Swati Amol Manerkar 
Designation  Additional Professor 
Affiliation  Lokmanya Tilak Municipal Medical College & General Hospital 
Address  Department of Neonatology Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone    
Fax    
Email  drswatimanerkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swati Amol Manerkar 
Designation  Additional Professor 
Affiliation  Lokmanya Tilak Municipal Medical College & General Hospital 
Address  Department of Neonatology Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone    
Fax    
Email  drswatimanerkar@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology Lokmanya Tilak Municipal Medical College & General Hospital, Sion, Mumbai 
 
Primary Sponsor  
Name  Swati Amol Manerkar 
Address  Department of Neonatology Lokmanya Tilak Municipal Medical College & General Hospital Sion Mumbai 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swati Amol Manerkar  Lokmanya Tilak Municipal Medical College & General Hospital  Department of Neonatology Lokmanya Tilak Municipal Medical College & General Hospital Sion Mumbai
Mumbai
MAHARASHTRA 
9769997968

drswatimanerkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All stable term and late preterm infants identified to have tongue tie on assessment. 
 
ExclusionCriteria 
Details  Preterms < 34 weeks,
Neurologically abnormal neonates,
Neonates with labial frenulum or other orofacial malformations 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 the mouth. (1) This may restrict normal tongue movements leading to difficulties in breastfeeding in the early neonatal period. Breastfeeding difficulties reported with tongue-tie include poor latch, poor milk transfer, maternal nipple pain, milk supply issues and poor infant weight gain. The prevalence of tongue tie varies from 10-46% as per various studies.  Frenotomy is a commonly suggested intervention in cases with tongue tie. The impact of frenotomy on reduction in nipple pain and increasing the ease of breastfeeding is known. Impact of frenotomy on improvement in breastfeeding is debatable.(2)

Coryllos and colleagues described anterior (types 1 and 2) and posterior tongue-ties (types 3 and 4).(3) Haham et al. examined the incidence of these types but did not find a difference in breastfeeding problems based on type. (4) Ghaheri et al. found an improvement in breastfeeding after laser frenotomy for anterior and posterior tongue-ties. (5) However, Douglas questions the widespread diagnosis of posterior tongue-ties and discusses the role of other factors in impaired tongue function (e.g., infant musculoskeletal tensions and breastfeeding positioning). (6) O’Callahan et al. retrospectively examined anterior and posterior tongue-ties; they found many infants with posterior ankyloglossia had persistent breastfeeding difficulties after initial anterior frenotomy. The breastfeeding issues improved only after the posterior frenotomy was performed. (7)

In our facility, we see several babies with tongue tie having feeding difficulties, poor latch and mothers complaining of breast and nipple pain. Very often these infants present with poor weight gain or excessive weight loss after birth.  Some of them undergo a frenotomy in order to facilitate proper latching at the breast and breastfeeding. The aim of this study was to study the breastfeeding outcomes of infants with tongue tie and determine if frenotomy improves breastfeeding outcomes 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 birth cohort

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

3.                Identify types and grade the severity of tongue tie

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

5.                Study maternal perception of breastfeeding pre and 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 tongue tie on assessment.

Exclusion criteria:

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

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

TABBY:

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

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

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

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

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

Nipple pain will be assessed on Likert scale of 1-10, 1 being no pain and 10 being maximum pain.

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

Mothers will receive breastfeeding support by counselling and practical help for positioning and achieving a deep latch, prone feeding etc. Frenotomy Decision tool for breastfeeding dyads (Carole Dobrich) will be used to decide eligibility for frenotomy by a certified lactation consultant. A score of >= 2 indicates need for frenotomy.

Once decision for frenotomy is taken, a written informed consent will be obtained from the parents.  The timing of frenotomy will be recorded (day of life). Frenotomy will be conducted by a trained surgeon.

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

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

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

 
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