Physiotherapy in the Treatment of Breastfeeding Difficulties

NCT05843279 | Completed DMC

• 1 other identifier: 35/2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Ankyloglossia; Lactation Disorders

Keywords

Breastfeeding; Ankyloglossia; Physiotherapy; Myofunctional Therapy; breastfeeding session

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  one month

Secondary Outcomes (2)

• Visual Analogue Scale

  one month

• Surgical intervention after treatment

  one month

Study Arms (2)

Myofunctional therapy

EXPERIMENTAL

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

Procedure: Myofunctional therapy

Breastfeeding session

OTHER

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

Interventions

Myofunctional therapy PROCEDURE

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

Breastfeeding session; Myofunctional therapy

Eligibility Criteria

• Age: 7 Days - 31 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full-term infants exclusively breastfed
• Born both by normal delivery and by cesarean section
• Who presented difficulty in breastfeeding

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Raúl Romero Del Rey

Almería, Almeria, Spain

Location

Related Publications (15)

• 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.

  PMID: 32283998 BACKGROUND

• 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/

  PMID: 27403491 BACKGROUND

• 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.

  PMID: 27641715 BACKGROUND

• 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.

  PMID: 35150472 BACKGROUND

• 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.

  PMID: 29620937 BACKGROUND

• 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.

  PMID: 12415069 BACKGROUND

• Campanha SMA, Martinelli RLC, Palhares DB. Association between ankyloglossia and breastfeeding. Codas. 2019 Feb 25;31(1):e20170264. doi: 10.1590/2317-1782/20182018264.

  PMID: 30810632 RESULT

• 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.

  PMID: 34267016 RESULT

• 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.

  PMID: 34813240 RESULT

• 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.

  PMID: 30954985 RESULT

• 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.

  PMID: 35930834 RESULT

• Manipon C. Ankyloglossia and the Breastfeeding Infant: Assessment and Intervention. Adv Neonatal Care. 2016 Apr;16(2):108-13. doi: 10.1097/ANC.0000000000000252.

  PMID: 27003478 RESULT

• 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.

  PMID: 36231647 RESULT

• 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.

  PMID: 29380619 RESULT

• Ferres-Amat E, Pastor-Vera T, Rodriguez-Alessi P, Ferres-Amat E, Mareque-Bueno J, Ferres-Padro E. Management of Ankyloglossia and Breastfeeding Difficulties in the Newborn: Breastfeeding Sessions, Myofunctional Therapy, and Frenotomy. Case Rep Pediatr. 2016;2016:3010594. doi: 10.1155/2016/3010594. Epub 2016 Aug 30.

  PMID: 27688921 RESULT

Related Links

• Recommendations on the duration of breastfeeding according to the World Health Organization (OMS)

MeSH Terms

Conditions

Breast Feeding; Ankyloglossia; Lactation Disorders

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Stomatognathic Diseases; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Myofunctional Therapy is performed in one group and a breastfeeding session is performed in another group.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)