An interventional study of Myofunctional therapy in Breastfeeding, Ankyloglossia and Lactation Disorders, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 7 Days to 31 Days. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
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:
The researchers will compare the results between these two groups in order to verify the best intervention.
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).
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention group receives myofunctional therapy sessions in which orofacial exercises are performed.
Procedure: Myofunctional therapy
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.
Also known as: Breastfeeding session
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.
Time frame: 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.
Time frame: 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.
Time frame: one month
Surgical intervention after treatment
If the baby needs frenectomy or frenotomy after the month of treatment
Time frame: one month
Plan to share: No
Ran from Jul 2023 to primary completion in Jul 2023, 0 months.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 0 months is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria