Physiotherapy in the Treatment of Breastfeeding Difficulties

Study Overview
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Brief Summary
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The objective of this randomized, single-blind clinical trial is to compare the efficacy of two treatments (Myofunctional Therapy and breastfeeding sessions) in infants who have difficulty breastfeeding during the first week of life. The main questions to be answered are: Is breastfeeding improved with this type of intervention? What type of intervention is better? After carrying out these interventions, does the baby need to undergo surgery if it presents a sublingual frenulum? Participants must be infants who are one week old and who have been diagnosed with ankyloglossia through the Hazelbaker Scale. They will be randomly distributed into the two intervention groups and after one month of treatment, they will be assessed again using the same scale. The researchers will compare the results between these two groups in order to verify the best intervention.

Detailed Description
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Infants who met the inclusion and exclusion criteria, respectively, were accepted to participate in the study. The randomization of the sample was performed by a statistician, who had no prior contact with either the infants or the parents. The online Randomizer (www.randomizer.org) program was used to randomly generate 200 sets of numbers, each containing two numbers ranging from 1 to 2 in random order. After signing the consent, a code was randomly chosen for each patient, thus ensuring that the 200 patients were equally distributed into two groups according to the group number of each code: group 1 (Myofunctional Therapy group) and group 2 (group sessions lactation). Infants who met the inclusion criteria were referred to the rehabilitation and physiotherapy service. A physical therapist outside the study was in charge of evaluating the measurements of all infants during the first week of life through all the scales detailed below (pre-test). After randomly assigning the infants, another physiotherapist was responsible for applying the intervention once a week for 30 minutes for a period of 30 days. Once the intervention was finished, all the infants (both intervention groups) were reassessed by the physiotherapist outside the study using the same baseline scales (post-test).

Official Title
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Efficacy of a Physiotherapy Treatment in Newborns With Breastfeeding Difficulties

Conditions
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Breastfeeding, Ankyloglossia, Lactation Disorders

Intervention / Treatment
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* Procedure: Myofunctional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term infants exclusively breastfed Born both by normal delivery and by cesarean section Who presented difficulty in breastfeeding Exclusion Criteria: Preterm newborns With low birth weight (less than 2,500 kg) Mothers with flat or inverted nipples Patients who did not wish and did not authorize to participate in the study.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 31 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Myofunctional Therapy is performed in one group and a breastfeeding session is performed in another group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofunctional therapy<br>The intervention group receives myofunctional therapy sessions in which orofacial exercises are performed. | Procedure: Myofunctional therapy<br>* In one group, physiotherapy intervention is performed on the orofacial structures of the baby and in another group, the posture presented by the mother while breastfeeding her baby is corrected.<br>* Other names: Breastfeeding session;|
| Other: Breastfeeding session<br>In this group, a session is held in which the posture and attachment of the baby to the mother's chest is assessed and corrected. | Procedure: Myofunctional therapy<br>* In one group, physiotherapy intervention is performed on the orofacial structures of the baby and in another group, the posture presented by the mother while breastfeeding her baby is corrected.<br>* Other names: Breastfeeding session;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazelbaker scale | This scale evaluates the appearance (5 items) and the function of the language (7 items). Each item is scored on a 2/1/0 scale (2 equals good appearance and/or full function; 1 equals moderate appearance and/or partial function; 0 equals no appearance and inadequate function). The maximum appearance score is 10, indicating that there are no limitations in the orofacial structures, and if it is less than 8, a limitation is confirmed. The maximum function score is 14, which reflects preserved function and if it is less than 11, the function is considered to be diminished. | one month | 
| Latch Scale | It is made up of different areas of assessment: how the baby latches on, amount of audible swallowing, type/condition of the mother's nipple, mother's comfort level, and amount of help the mother needs to latch on. baby at the breast The rating system is 0/1/2 in each item (0 equals the least favourable and 2 the most favourable). The highest score is 10, which means that there is no problem in breastfeeding. If the score is less than 9, it means that the mother and baby need help with breastfeeding. | one month | 
| Visual Analogue Scale | This scale evaluates the pain suffered by the mother's nipple while the child is breastfeeding. The maximum score is 10 (unbearable pain) and the minimum score is 0 (no pain). Higher scores mean more breastfeeding problems and the need for help from a health professional. | one month | 
| Surgical intervention after treatment | If the baby needs frenectomy or frenotomy after the month of treatment | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant sex | if the baby is male or female | one day | 
| mother's age at delivery | mother's age when her baby is born | one day | 
| gestational age | weeks of gestation of the baby | one day | 
| mother's educational level | If the mother has primary or higher education | one day | 
| mother's marital status | single or married | one day | 
| type of delivery | vaginal delivery or caesarean section | one day | 
| Number of births including the present | Number of births including the present | one day | 
| Coryllos and Catherine Watson Genna's type of frenulum classification | Type of sublingual frenulum | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Ankyloglossia, Physiotherapy, Myofunctional Therapy, breastfeeding session