Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial

Study Overview
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Brief Summary
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The investigators are registering a randomised controlled trial to assess whether dedicated, intensified lactation support is as good as frenotomy on the incidence of breastfeeding among term infants with ankyloglossia.

Detailed Description
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The investigators plan to include a total 316 infants. The study will be carried out in level III hospital in Warsaw, Poland. The primary outcome will be exclusive breastfeeding at 12 weeks of age. Secondary outcomes include breastfeeding > 50% of feedings, improved breastfeeding comfort as assessed by the mother, weight gain, head circumference and length gain, the need to use a breast pump or lactation accessories, time of breastfeeding cessation, the type of lactation, neurological and rehabilitation assistance received, the frequency of obtained lactation, neurological and rehabilitation assistance.

Official Title
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Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial

Conditions
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Ankyloglossia, Breast Feeding, Exclusive, Lactation Failure, Tongue-tie

Intervention / Treatment
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* Procedure: phrenectomy
* Other: Increased lactation support


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: full - term infants born with an Apgar score of 8-10 points no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry) parental consent Exclusion criteria: hypotrophy low birth weight perinatal complications congenital craniofacial defects neurological diseases visible genetic syndromes mother' unwilling to breastfeed no consent for vaccination against hepatitis B neonates born to HIV seropositive mothers

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL GROUP<br>The qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function. | Procedure: phrenectomy<br>* The qualification for phrenectomy in group 1 will be made based on the Amir scale, i.e. a score of 4 and fewer points for the language function (2).<br>|
| Experimental: STUDY GROUP<br>Management in group 2 will include increased lactation care both during hospital stay and post discharge. Increased lactation care will consist of: individual consultations on how to properly attach the baby to the breast (at least 3 meetings during hospitalization with personnel trained in lactation counselling), regular (at least once a week) contact with a breastfeeding consultant as part of a closed group on social media or by phone, if necessary (expressed by the mother or based on a referral by a member of the lactation team) an outpatient appointment at the breastfeeding clinic. | Other: Increased lactation support<br>* Management in group 2 will include increased lactation care both during hospital stay and post discharge.<br>* Other names: dedicated lactation support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of exclusively breastfeeding mothers | Proportion of exclusively breastfeeding mothers | at 12 weeks of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of mother-baby dyads with a breastfeeding frequency of > 50%. | Proportion of mother-baby dyads with a breastfeeding frequency of > 50% of feedings, which will be assessed using the Breastfeeding Self-Efficacy Scale Short Form [9, 10] | at 12 weeks of age | 
| Weight change | Median weight change | at 12 weeks of age | 
| Head circumference change | Median head circumference change | at 12 weeks of age | 
| Length change | Median length change | at 12 weeks of age | 
| Incidence of using a breast pump or lactation accessories | Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields) | at 12 weeks of age | 
| Time of breastfeeding cessation | median time of breastfeeding cessation | during 12 weeks of age | 
| Rate of additional consultations | Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads. | during 12 weeks of age | 
| Change in breastfeeding comfort | Proportion of mothers reporting change in breastfeeding comfort | at 12 weeks of age |