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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
Intervention / Comparator Agent
|
|
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. |