Breastfeeding Duration and Tongue-tie in Neonates.

Infant Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05946590
• Other study ID #: VEC 99694
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 49 Days

Eligibility

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.

Related Conditions & MeSH terms

• Ankyloglossia
• Infant Nutrition Disorders
• Nutrition Disorders

Intervention

Procedure:
• Frenotomy
Frenotomy in which clipping/incised of the lingual frenulum releases the tongue-tie performed by a health care professional

Locations

Country	Name	City	State
Denmark	Diana Skaaning	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding duration	The duration of exclusive and partial breastfeeding	Followed 6 months.
Secondary	TABBY score	The association between tongue-tie, TABBY score, and vacuum strength.	Before and 5-10 days after performed frenotomy.
Secondary	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.