Breastfeeding and reflux improvement, the effect of frenulotomy

Not Applicable

Completed

• Conditions: ewborns with untreated ankyloglossia and/or tethered maxillary labial frenula with breastfeeding (and reflux) problems.; Nutritional, Metabolic, Endocrine; Newborns with untreated ankyloglossia and/or tethered maxillary labial frenula with breastfeeding (and reflux) problems.

• Registration Number: ISRCTN64428423
• Lead Sponsor: niversity Medical Centre Groningen

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33315177/ (added 26/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-21
• Study Completion: 2018-12-01
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. Newborns under 6 months
2. Are breast fed
3. Untreated ankyloglossia and/or tethered maxillary labial frenula

Exclusion Criteria

1. Older then 6 months
2. Premature born
3. Unhealthy
4. Formula fed
5. Already revised ankyloglossia and/or tethered maxillary labial frenula

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breastfeeding improvement is measured using the BSES-SF (Breastfeeding Self-Efficacy Scale Short Form) questionnaire at one week, one month and six months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Reflux improvement is emasured using the I-GERQ-R (Infant-Gastroesophagal Reflux Questionnaire- Revised) at one week, one month and six months<br> 2. Pain during breastfeeding is measured using the Visual Analogue Scale (VAS) at one week, one month and six months.<br>