Physiotherapy in the Treatment of Breastfeeding Difficulties

July 29, 2024 updated by: Gemma María López Segura, Universidad de Almeria

Efficacy of a Physiotherapy Treatment in Newborns With Breastfeeding Difficulties

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • Almería, Almeria, Spain
        • Raúl Romero Del Rey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myofunctional therapy
The intervention group receives myofunctional therapy sessions in which orofacial exercises are performed.
Procedure: Myofunctional therapy
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.
Other Names:
  • Breastfeeding session
Other: Breastfeeding session
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
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.
Other Names:
  • Breastfeeding session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hazelbaker scale
Time Frame: one month
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
Time Frame: one month
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical intervention after treatment
Time Frame: one month
If the baby needs frenectomy or frenotomy after the month of treatment
one month
Visual Analogue Scale
Time Frame: one month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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