An interventional study of Frenotomy in Infant Nutrition Disorders, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged Up to 49 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Infant Nutrition Disorders; 14 are open to participants now.
This study's enrollment of 100 is below the median of 180 across 46 interventional studies indexed under Infant Nutrition Disorders.
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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.
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
Also known as: Frenulum release
Breastfeeding duration
The duration of exclusive and partial breastfeeding
Time frame: Followed 6 months.
TABBY score
The association between tongue-tie, TABBY score, and vacuum strength.
Time frame: 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
Time frame: Before, within 1 hour after and 5-10 days after performed frenotomy.
Plan to share: No — 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.
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Nov 2024, 11 months.
Of 25 interventional studies with no phase under Infant Nutrition Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 27. This study's 11 months is close to that.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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