An observational study in Tongue Tie and Ankyloglossia, sponsored by University of Oslo. Status unknown. Open to participants aged 1 Day to 2 Weeks. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by University of Oslo · Observational
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.
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:
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
Browse Ankyloglossia studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
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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.
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Exclusion Criteria:
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
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 the infants born in the study period that will contribute to the prevalence study.
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.
Also known as: Breastfeeding support
Prevalence of ankyloglossia in Norway
The to assess the prevalence of tongue-tie in newborn infants in Norway.
Time frame: September 2019 - August 2021
Proportion of infants treated with a frenotomy
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.
Time frame: September 2019 - December 2021
Variations in diagnosis of tongue tie and breastfeeding outcomes
Number of infants with the diagnosis Q38.1 in the intervention counties compared to counties that are not a part of the study.
Time frame: September 2019 - December 2021
Severity of breastfeeding problems
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.
Time frame: September 2019 - December 2021
Adverse events
Severity of adverse events related to the treatment of the infant as assessed by CTCAE v5.0.
Time frame: September 2019 - December 2021
Long term followup - Breastfeeding duration and introduction of solids
Duration of any breastfeeding in months and any problems with the introduction of solids is mapped 3 years after inclusion in the study.
Time frame: September 2019 - August 2023
Long term followup - Speech development
Problems with child's speech development at the age of 3 years. Referral to treatment by Speech Language Pathologist.
Time frame: September 2019 - August 2023
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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