Clinical trial NCT05946590: Breastfeeding Duration and Tongue-tie in Neonates.
Official title: The Duration of Exclusive Breastfeeding and Tongue-tie in Neonates.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Nutrition Disorders
Keywords: Ankyloglossia
Frenotomy
Infants
Intra-oral vacuum
Breastfeeding
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Maximum age (years): 49
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An exploratory prospective cohort study.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breastfeeding duration
timeFrame: Followed 6 months.
Secondary outcomes:
measure: TABBY score
timeFrame: Before and 5-10 days after performed frenotomy.
measure: Delta intra-oral vacuum
timeFrame: Before, within 1 hour after and 5-10 days after performed frenotomy.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Diana Skaaning
state: Copenhagen
Study officials:
affiliation: Region Hovedstadens Apotek
name: Diana Skaaning
role: PRINCIPAL_INVESTIGATOR
References: