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Breastfeeding and reflux improvement, the effect of frenulotomy

Breastfeeding improvement after frenectomy tongue- and lip tie

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN64428423
Enrollment
152
Registered
2017-09-21
Start date
2017-10-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborns 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.

Interventions

Study enrollment and informed consent were completed subsequent to standard surgical consent. Participants were orally examined if restrictions were present and standardized classification systems wer

Sponsors

University Medical Centre Groningen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026