Intra-oral Vacuum in Infants Before and After Performed Frenotomy
Primary Purpose
Infant Nutrition Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Frenotomy
Sponsored by
About this trial
This is an interventional treatment trial for Infant Nutrition Disorders focused on measuring Ankyloglossia, Frenotomy, Infants, Intra-oral vacuum, Breastfeeding
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Frenotomy
Arm Description
Frenotomy performed by a health care professional
Outcomes
Primary Outcome Measures
Delta intra-oral vacuum
The primary outcome is to investigate any difference in vacuum in infants below 42 days measured before and 5-10 days after frenotomy performed.
Secondary Outcome Measures
TABBY score
The association between tongue-tie, TABBY score, and vacuum strength.
Breastfeeding duration
The duration of exclusive and partial breastfeeding
Full Information
NCT ID
NCT05946590
First Posted
June 29, 2023
Last Updated
July 21, 2023
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05946590
Brief Title
Intra-oral Vacuum in Infants Before and After Performed Frenotomy
Official Title
Intra-oral Vacuum in Infants Before and After Performed Frenotomy - the ReVac Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this observational study is to examine how performed frenotomy in term-born infants influences the intra-oral vacuum. The main questions the study aims to answer are how tongue-tie, vacuum strength, and breastfeeding may be associated. Families of infants with tongue-tie where frenotomy is performed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Nutrition Disorders
Keywords
Ankyloglossia, Frenotomy, Infants, Intra-oral vacuum, Breastfeeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An exploratory prospective cohort study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Frenotomy
Arm Type
Other
Arm Description
Frenotomy performed by a health care professional
Intervention Type
Procedure
Intervention Name(s)
Frenotomy
Other Intervention Name(s)
Frenulum release
Intervention Description
Frenotomy in which clipping/incised of the lingual frenulum releases the tongue-tie performed by a health care professional
Primary Outcome Measure Information:
Title
Delta intra-oral vacuum
Description
The primary outcome is to investigate any difference in vacuum in infants below 42 days measured before and 5-10 days after frenotomy performed.
Time Frame
Before, within 1 hour after and 5-10 days after performed frenotomy.
Secondary Outcome Measure Information:
Title
TABBY score
Description
The association between tongue-tie, TABBY score, and vacuum strength.
Time Frame
Before and 5-10 days after performed frenotomy.
Title
Breastfeeding duration
Description
The duration of exclusive and partial breastfeeding
Time Frame
Followed 6 months.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
42 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Intra-oral Vacuum in Infants Before and After Performed Frenotomy
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