CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Myofunctional therapyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05843279
NCT05843279N/ACompleted

Efficacy of a Physiotherapy Treatment in Newborns With Breastfeeding Difficulties

Universidad de Almeria·interventional·Posted May 6, 2023·Updated Jul 31, 2024

In Brief

A clinical study evaluating Myofunctional therapy for Breastfeeding and 2 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMay 6, 2023
Enrollment StartJul 1, 2023
Primary CompletionJul 1, 2023
Study CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 3.2 years ago

Interventions

Myofunctional therapyprocedure

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.