Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05843279
Other study ID # 35/2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date November 1, 2023

Study information

Verified date May 2023
Source Universidad de Almeria
Contact Gemma María López Segura, Physiotherapy graduate
Phone 610024516
Email gemalose@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Days to 31 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Almeria

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. 20 — View 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. — View 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/ — View 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. — View 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: 10.33 — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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. one month
Primary Surgical intervention after treatment If the baby needs frenectomy or frenotomy after the month of treatment one month
Secondary infant sex if the baby is male or female one day
Secondary mother's age at delivery mother's age when her baby is born one day
Secondary gestational age weeks of gestation of the baby one day
Secondary mother's educational level If the mother has primary or higher education one day
Secondary mother's marital status single or married one day
Secondary type of delivery vaginal delivery or caesarean section one day
Secondary Number of births including the present Number of births including the present one day
Secondary Coryllos and Catherine Watson Genna's type of frenulum classification Type of sublingual frenulum one day
See also
  Status Clinical Trial Phase
Completed NCT00579605 - Motivational Interviewing to Promote Sustained Breastfeeding N/A
Completed NCT05655364 - Development of a Breastfeeding Supportive Mobile Application N/A
Completed NCT03853850 - Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island N/A
Completed NCT03957941 - FamilyLink and Breastfeeding N/A
Withdrawn NCT03709004 - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression N/A
Completed NCT02958475 - Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers N/A
Active, not recruiting NCT05503069 - Community Interventions to Improve Breastfeeding N/A
Not yet recruiting NCT02233439 - Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues N/A
Completed NCT01893736 - Professional Breastfeeding Support Intervention N/A
Completed NCT02738957 - Effect of Prenatal Counseling on Breastfeeding Rates in Twins N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Completed NCT03655314 - Using the Electronic Health Record to Guide Management of Newborn Weight Loss N/A
Completed NCT05562245 - Motivational Interviewing-Based Breastfeeding Education N/A
Completed NCT05106634 - Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Recruiting NCT05250219 - Microchimeric Cell Tranfer From Mother to Child - Pilo Study
Recruiting NCT05213975 - Kinesio Taping Application After Cesarean Section N/A
Recruiting NCT05371106 - Mycotoxins in Mothers Milk in Israel
Completed NCT03332108 - Novel Approach To Improving Lactation Support With Mobile Health Technology N/A
Completed NCT02901665 - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes N/A