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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
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 42 Days (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 29, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Hvidovre University Hospital
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    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.

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    Intra-oral Vacuum in Infants Before and After Performed Frenotomy

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