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Physiotherapy in the Treatment of Breastfeeding Difficulties

Primary Purpose

Breastfeeding, Ankyloglossia, Lactation Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Myofunctional therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breastfeeding focused on measuring Breastfeeding, Ankyloglossia, Physiotherapy, Myofunctional Therapy, breastfeeding session

Eligibility Criteria

7 Days - 31 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Myofunctional therapy

    Breastfeeding session

    Arm Description

    The intervention group receives myofunctional therapy sessions in which orofacial exercises are performed.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    Surgical intervention after treatment
    If the baby needs frenectomy or frenotomy after the month of treatment

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    May 5, 2023
    Sponsor
    Universidad de Almeria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05843279
    Brief Title
    Physiotherapy in the Treatment of Breastfeeding Difficulties
    Official Title
    Efficacy of a Physiotherapy Treatment in Newborns With Breastfeeding Difficulties
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Almeria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breastfeeding, Ankyloglossia, Lactation Disorders
    Keywords
    Breastfeeding, Ankyloglossia, Physiotherapy, Myofunctional Therapy, breastfeeding session

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Myofunctional Therapy is performed in one group and a breastfeeding session is performed in another group.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    A physiotherapist outside the study was in charge of carrying out the first evaluation in the first week of life of the infant. Another physiotherapist was in charge of applying the physiotherapy intervention. After completion of the intervention, all infants were reassessed by another physiotherapist outside the study.
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Myofunctional therapy
    Arm Type
    Experimental
    Arm Description
    The intervention group receives myofunctional therapy sessions in which orofacial exercises are performed.
    Arm Title
    Breastfeeding session
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Myofunctional therapy
    Other Intervention Name(s)
    Breastfeeding session
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Hazelbaker scale
    Description
    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
    Title
    Latch Scale
    Description
    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
    Title
    Visual Analogue Scale
    Description
    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
    Title
    Surgical intervention after treatment
    Description
    If the baby needs frenectomy or frenotomy after the month of treatment
    Time Frame
    one month
    Secondary Outcome Measure Information:
    Title
    infant sex
    Description
    if the baby is male or female
    Time Frame
    one day
    Title
    mother's age at delivery
    Description
    mother's age when her baby is born
    Time Frame
    one day
    Title
    gestational age
    Description
    weeks of gestation of the baby
    Time Frame
    one day
    Title
    mother's educational level
    Description
    If the mother has primary or higher education
    Time Frame
    one day
    Title
    mother's marital status
    Description
    single or married
    Time Frame
    one day
    Title
    type of delivery
    Description
    vaginal delivery or caesarean section
    Time Frame
    one day
    Title
    Number of births including the present
    Description
    Number of births including the present
    Time Frame
    one day
    Title
    Coryllos and Catherine Watson Genna's type of frenulum classification
    Description
    Type of sublingual frenulum
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    31 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gemma María López Segura, Physiotherapy graduate
    Phone
    610024516
    Email
    gemalose@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32283998
    Citation
    Messner AH, Walsh J, Rosenfeld RM, Schwartz SR, Ishman SL, Baldassari C, Brietzke SE, Darrow DH, Goldstein N, Levi J, Meyer AK, Parikh S, Simons JP, Wohl DL, Lambie E, Satterfield L. Clinical Consensus Statement: Ankyloglossia in Children. Otolaryngol Head Neck Surg. 2020 May;162(5):597-611. doi: 10.1177/0194599820915457. Epub 2020 Apr 14.
    Results Reference
    background
    PubMed Identifier
    27403491
    Citation
    Frenectomy for the Correction of Ankyloglossia: A Review of Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Jun 15. Available from http://www.ncbi.nlm.nih.gov/books/NBK373454/
    Results Reference
    background
    PubMed Identifier
    27641715
    Citation
    Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19.
    Results Reference
    background
    PubMed Identifier
    35150472
    Citation
    Bruney TL, Scime NV, Madubueze A, Chaput KH. Systematic review of the evidence for resolution of common breastfeeding problems-Ankyloglossia (Tongue Tie). Acta Paediatr. 2022 May;111(5):940-947. doi: 10.1111/apa.16289. Epub 2022 Feb 21.
    Results Reference
    background
    PubMed Identifier
    29620937
    Citation
    Walker RD, Messing S, Rosen-Carole C, McKenna Benoit M. Defining Tip-Frenulum Length for Ankyloglossia and Its Impact on Breastfeeding: A Prospective Cohort Study. Breastfeed Med. 2018 Apr;13(3):204-210. doi: 10.1089/bfm.2017.0116. Epub 2018 Mar 20.
    Results Reference
    background
    PubMed Identifier
    12415069
    Citation
    Ballard JL, Auer CE, Khoury JC. Ankyloglossia: assessment, incidence, and effect of frenuloplasty on the breastfeeding dyad. Pediatrics. 2002 Nov;110(5):e63. doi: 10.1542/peds.110.5.e63.
    Results Reference
    background
    PubMed Identifier
    30810632
    Citation
    Campanha SMA, Martinelli RLC, Palhares DB. Association between ankyloglossia and breastfeeding. Codas. 2019 Feb 25;31(1):e20170264. doi: 10.1590/2317-1782/20182018264.
    Results Reference
    result
    PubMed Identifier
    34267016
    Citation
    Colombari GC, Mariusso MR, Ercolin LT, Mazzoleni S, Stellini E, Ludovichetti FS. Relationship between Breastfeeding Difficulties, Ankyloglossia, and Frenotomy: A Literature Review. J Contemp Dent Pract. 2021 Apr 1;22(4):452-461.
    Results Reference
    result
    PubMed Identifier
    34813240
    Citation
    Costa-Romero M, Espinola-Docio B, Paricio-Talayero JM, Diaz-Gomez NM. Ankyloglossia in breastfeeding infants. An update. Arch Argent Pediatr. 2021 Dec;119(6):e600-e609. doi: 10.5546/aap.2021.eng.e600. English, Spanish.
    Results Reference
    result
    PubMed Identifier
    30954985
    Citation
    Brzecka D, Garbacz M, Mical M, Zych B, Lewandowski B. Diagnosis, classification and management of ankyloglossia including its influence on breastfeeding. Dev Period Med. 2019;23(1):79-87. doi: 10.34763/devperiodmed.20192301.7985.
    Results Reference
    result
    PubMed Identifier
    35930834
    Citation
    Wen Z, Walner DL, Popova Y, Walner EG. Tongue-tie and breastfeeding. Int J Pediatr Otorhinolaryngol. 2022 Sep;160:111242. doi: 10.1016/j.ijporl.2022.111242. Epub 2022 Jul 20.
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    27003478
    Citation
    Manipon C. Ankyloglossia and the Breastfeeding Infant: Assessment and Intervention. Adv Neonatal Care. 2016 Apr;16(2):108-13. doi: 10.1097/ANC.0000000000000252.
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    Citation
    Gonzalez Garrido MDP, Garcia-Munoz C, Rodriguez-Huguet M, Martin-Vega FJ, Gonzalez-Medina G, Vinolo-Gil MJ. Effectiveness of Myofunctional Therapy in Ankyloglossia: A Systematic Review. Int J Environ Res Public Health. 2022 Sep 28;19(19):12347. doi: 10.3390/ijerph191912347.
    Results Reference
    result
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    29380619
    Citation
    Ferres-Amat E, Pastor-Vera T, Rodriguez-Alessi P, Ferres-Amat E, Mareque-Bueno J, Ferres-Padro E. The prevalence of ankyloglossia in 302 newborns with breastfeeding problems and sucking difficulties in Barcelona: a descriptive study. Eur J Paediatr Dent. 2017 Dec;18(4):319-325. doi: 10.23804/ejpd.2017.18.04.10.
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    Results Reference
    result
    Links:
    URL
    https://www.who.int/es/
    Description
    Recommendations on the duration of breastfeeding according to the World Health Organization (OMS)

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    Physiotherapy in the Treatment of Breastfeeding Difficulties

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