Breastfeeding Duration and Tongue-tie in Neonates.

The Duration of Exclusive Breastfeeding and Tongue-tie in Neonates.

The goal of this observational study is to examine how performed frenotomy in term-born infants influences the breastfeeding duration. The main questions the study aims to answer are how a suspected tongue-tie, vacuum strength, and breastfeeding may be associated. Families of infants with tongue-tie where frenotomy is suspected will be invited to participate. Intra-oral vacuum measurements before and 5-10 days after frenotomy will be obtained and the breastfeeding status followed for 6 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Infant Nutrition Disorders
• Intervention / Treatment: Procedure: Frenotomy

Detailed Description

Exclusive breastfeeding is defined as feeding the infant with human breast milk only, except for vitamins, minerals supplements and medicine. It is an official recommendation that infants are exclusively breastfed for 6 months. Approximately 60% and 15% of Danish infants are exclusively breastfed for 4 and 6 months respectively. There are many factors that may interfere with the establishment and duration of breastfeeding.

For the infant, breastfeeding depends on the infant´s ability to seal the oral cavity around the breast and integrate the muscular activities of cheeks, lips, jaw, and tongue. Effectively nutritive sucking occurs due to the application of positive pressure when the tongue moves upwards to express milk, followed by an intra-oral vacuum (vacuum) when the tongue moves downwards and draws milk from the breast by suction. The strength of vacuum affects the effectiveness of milk removal from the breast and regulates the volume of milk. A weak vacuum may, therefore, lead to a shortage of milk transfer, diminished milk supply and early breastfeeding stop. Conversely, was in a recently published study found an association between a high vacuum and infants who were exclusively breastfed for the recommended 6 months.

Difficulties in creating an appropriate vacuum may be related to ankyloglossia, tight frenulum also called tongue-tie, a condition in which the lingual frenulum has anterior attachment near the tip of the tongue and/or are unusually thick, tight, and/or short lingual frenulum. Tongue-tie is often detected when the infant shows signs of difficulties during breastfeeding and/or there is maternal nipple pain. The possible consequence of tongue-tie is insufficient infant weight gain, neonatal dehydration, and shortened breastfeeding duration.

In case of breastfeeding difficulties, it is recommended to evaluate the tongue-tie by the Breastfed Babies Assessment Tool score (TABBY) and depending on this assessment frenotomy may be recommended. The value of both the TABBY score and frenotomy is only poorly validated.

Hypothesis We hypothesise vacuum to increase after frenotomy and, thereby, affect breastfeeding duration positively.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana Skaaning; Phone Number: +4521295058; Email: diana.skaaning@regionh.dk

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Diana Skaaning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Infant of an adult mother Delivery after 37 completed gestational weeks. Singleton or twin Infant of a mother who intends to breastfeed. At least one parents speak and write English, Danish, Norwegian, or Swedish.

Exclusion Criteria:

Congenital malformation. Reduced lung function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Frenotomy; Frenotomy performed by a health care professional	Procedure: Frenotomy; Frenotomy in which clipping/incised of the lingual frenulum releases the tongue-tie performed by a health care professional; Other Names: Frenulum release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration	The duration of exclusive and partial breastfeeding	Followed 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TABBY score	The association between tongue-tie, TABBY score, and vacuum strength.	Before and 5-10 days after performed frenotomy.
Delta intra-oral vacuum	The primary outcome is to investigate any difference in vacuum in infants below 42 days	Before, within 1 hour after and 5-10 days after performed frenotomy.

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Diana Skaaning, Region Hovedstadens Apotek

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Infants; Breastfeeding; Ankyloglossia; Frenotomy; Intra-oral vacuum
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nutrition Disorders; Infant Nutrition Disorders; Ankyloglossia
• Other Study ID Numbers: VEC 99694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All personal information about potential and enrolled participants will be collected, shared, and maintained under protected confidentiality before, during, and after the study period according to Capital Region at Knowledge Center for Data Reviews and the General Data Protection Regulation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No