Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial
- Conditions
- AnkyloglossiaTongue-tieBreast Feeding, ExclusiveLactation Failure
- Registration Number
- NCT05135481
- Lead Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of exclusively breastfeeding mothers at 12 weeks of age Proportion of exclusively breastfeeding mothers
- Secondary Outcome Measures
Name Time Method Proportion of mother-baby dyads with a breastfeeding frequency of > 50%. at 12 weeks of age 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 \[9, 10\]
Weight change at 12 weeks of age Median weight change
Head circumference change at 12 weeks of age Median head circumference change
Length change at 12 weeks of age Median length change
Change in breastfeeding comfort at 12 weeks of age Proportion of mothers reporting change in breastfeeding comfort
Time of breastfeeding cessation during 12 weeks of age median time of breastfeeding cessation
Incidence of using a breast pump or lactation accessories at 12 weeks of age Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields)
Rate of additional consultations during 12 weeks of age Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads.
Trial Locations
- Locations (1)
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
🇵🇱Warsaw, Poland
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University🇵🇱Warsaw, Poland