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Completed

NCT Number: NCT05946590

Breastfeeding Duration 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.

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Key information

Age range

Up to 49 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diana Skaaning

Hvidovre, Copenhagen, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frenotomy

Procedure

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

Other names: Frenulum release

Primary outcomes

  1. Breastfeeding duration

    Time frame: Followed 6 months.

    The duration of exclusive and partial breastfeeding

Secondary outcomes

  1. TABBY score

    Time frame: Before and 5-10 days after performed frenotomy.

    The association between tongue-tie, TABBY score, and vacuum strength.

  2. Delta intra-oral vacuum

    Time frame: Before, within 1 hour after and 5-10 days after performed frenotomy.

    The primary outcome is to investigate any difference in vacuum in infants below 42 days

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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