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The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health

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ClinicalTrials.gov Identifier: NCT04056936
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
The Hospital of Vestfold
Oslo University Hospital
Sykehuset Telemark
Information provided by (Responsible Party):
Atle Klovning, University of Oslo

Brief Summary:
The study is a prospective multi-centre clinical follow-up study of prevalence and severity of tongue-tie in neonates in Norway. During one year around 2600 newborn infants will be examined for tongue-tie in the two participating hospitals. The infants diagnosed with a tongue tie, will be followed to assess the proportion of infants treated and the severity. Feeding outcomes will be observed up to 6 months of age.

Condition or disease Intervention/treatment
Tongue Tie Ankyloglossia Procedure: Frenotomy

Detailed Description:

A tongue-tie may cause problems for child and mother. There are no previous studies from Norway that have assessed the magnitude and severity of tongue-tie in infants. The prevalence of tongue-tie in Norway and to what degree it influences mother and child health is unknown. It is of great importance to address a problem with possible negative effect on breastfeeding and maternal and child health. Current clinical practice varies due to incomplete knowledge of the condition. An unknown proportion of infants with tongue-tie may not be diagnosed or receive treatment. Current international research recommends treatment of tongue-tie if it causes breastfeeding problems. This project will add significant knowledge about tongue-tie in Norway.

The project supports:

  • Filling knowledge gaps by researching the prevalence and severity of the condition.
  • Obtaining new knowledge for the health services by establishing assessment of tongue-tie prevalence in Norway. This can be used for planning of the healthcare services.
  • Improving existing practice by describing the condition and implementing best practice diagnosis and treatment.
  • Creating societal benefits by improving infant nutrition and maternal health.

During the year of the study, the pediatricians at each hospital will assess the prevalence of tongue-tie in all newborn infants in their hospital. The examination will be part of the standard newborn examination which usually takes place during the 2nd day of life. A simple and short registration form will be filled out electronically, noting the type of tongue-tie and symptoms for each infant with the diagnosis. In addition, the diagnosis Ankyloglossia Q38.1 will be registered in the electronic journal system. The examination of the infant's mouth is completely safe and is already performed to asses if there is a cleft palate. The pediatrician will examine the area under the tongue in addition to the palate. All newborn infants will be examined to obtain a trustworthy prevalence. If a frenotomy is required and performed, this will be registered in the registration form and the procedure code for frenotomy EJC 20 will be registered in the electronic journal system. The breastfeeding self-efficacy tool (BSES-SF) is used for patient reported outcome measures.as well as WHO's breastfeeding indicators

To map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition the investigators will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Scope of Tongue-tie in Norway: Its Prevalence and Consequences for Child Health
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Infants diagnosed with a tongue-tie and a frenotomy
If a tongue-tie is present at the routine newborn examination, the infant can be included in the study. If the infant also has breastfeeding problems and there is a decreased tongue mobility and poor sucking ability, the pediatrician may find indication for frenotomy. If the frenotomy is performed before discharge the infant is included in this group. All Mother-infant dyads will get breastfeeding support.
Procedure: Frenotomy
To map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition we will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie.
Other Name: Breastfeeding support

Infants diagnosed with a tongue-tie and no frenotomy
The infants that are recruited to the tongue-tie cohort that do not receive treatment before discharge. The pediatrician evaluates that the tongue tie does not cause any functional problems and no treatment is performed before discharge. All Mother-infant dyads will get breastfeeding support.
All infants born in Telemark and Vestfold Counties
All the infants born in the study period that will contribute to the prevalence study.



Primary Outcome Measures :
  1. Prevalence of ankyloglossia in Norway [ Time Frame: September 2019 - August 2021 ]
    The to assess the prevalence of tongue-tie in newborn infants in Norway.


Secondary Outcome Measures :
  1. Proportion of infants treated with a frenotomy [ Time Frame: September 2019 - December 2021 ]
    The number of infants treated on indication after the standardized diagnostic approach and the method of treatment have been introduced in the centers of intervention.

  2. Variations in diagnosis of tongue tie and breastfeeding outcomes [ Time Frame: September 2019 - December 2021 ]
    Number of infants with the diagnosis Q38.1 in the intervention counties compared to counties that are not a part of the study.

  3. Severity of breastfeeding problems [ Time Frame: September 2019 - December 2021 ]
    Breastfeeding problems and the duration of exclusive breastfeeding measured in months in the tongue tied infants that receive treatment compared to those who are not treated.

  4. Adverse events [ Time Frame: September 2019 - December 2021 ]
    Severity of adverse events related to the treatment of the infant as assessed by CTCAE v5.0.


Other Outcome Measures:
  1. Long term followup - Breastfeeding duration and introduction of solids [ Time Frame: September 2019 - August 2023 ]
    Duration of any breastfeeding in months and any problems with the introduction of solids is mapped 3 years after inclusion in the study.

  2. Long term followup - Speech development [ Time Frame: September 2019 - August 2023 ]
    Problems with child's speech development at the age of 3 years. Referral to treatment by Speech Language Pathologist.



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Infants 0 days to 2 weeks old diagnosed with a tongue tie in the counties of Telemark and Vestfold during the study enrollment period September 2019 - August 2020.
Criteria

Inclusion Criteria:

  • Subject must be born in a participating hospital during the study period.
  • Subjects that are recruited for follow-up must have a diagnose of tongue-tie as determined by the pediatrician in the hospital.
  • Infants with a tongue-tie that have been treated with a frenotomy and infants that have not received treatment.

Exclusion Criteria:

  • Infants where the parents do not wish to participate in the study or where the parents do not to understand English or Norwegian.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056936


Contacts
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Contact: Rønnaug Solberg, MD, PhD + 47-91843808 Ronnaug.Solberg@rr-research.no
Contact: Solveig T Holmsen, MD, MPH +47-95824029 soholm@ous-hf.no

Sponsors and Collaborators
University of Oslo
The Hospital of Vestfold
Oslo University Hospital
Sykehuset Telemark
Investigators
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Study Director: Atle Klovning, MD. PhD University of Oslo

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Responsible Party: Atle Klovning, MD. PhD. Associate Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT04056936    
Other Study ID Numbers: 2018/FO201556
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atle Klovning, University of Oslo:
Breastfeeding
Lactational mastitis
Infant nutrition
Infant growth
Speech development
Frenotomy
Additional relevant MeSH terms:
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Ankyloglossia
Stomatognathic Diseases