Clinical trial NCT05843279: Physiotherapy in the Treatment of Breastfeeding Difficulties
Official title: Efficacy of a Physiotherapy Treatment in Newborns With Breastfeeding Difficulties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Ankyloglossia
Lactation Disorders
Keywords: Breastfeeding
Ankyloglossia
Physiotherapy
Myofunctional Therapy
breastfeeding session
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Myofunctional Therapy is performed in one group and a breastfeeding session is performed in another group.
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hazelbaker scale
timeFrame: one month
measure: Latch Scale
timeFrame: one month
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: one month
measure: Surgical intervention after treatment
timeFrame: one month
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Raúl Romero Del Rey
state: Almeria
Study officials:
References:
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