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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
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).
Management in group 2 will include increased lactation care both during hospital stay and post discharge.
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, Poland
Proportion of exclusively breastfeeding mothers
Proportion of exclusively breastfeeding mothers
Time frame: at 12 weeks of age
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 \[9, 10\]
Time frame: at 12 weeks of age
Weight change
Median weight change
Time frame: at 12 weeks of age
Head circumference change
Median head circumference change
Time frame: at 12 weeks of age
Length change
Median length change
Time frame: 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)
Time frame: at 12 weeks of age
Time of breastfeeding cessation
median time of breastfeeding cessation
Time frame: 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.
Time frame: during 12 weeks of age
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Change in breastfeeding comfort
Proportion of mothers reporting change in breastfeeding comfort
Time frame: at 12 weeks of age