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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05135481
Study type Interventional
Source Princess Anna Mazowiecka Hospital, Warsaw, Poland
Contact
Status Withdrawn
Phase N/A
Start date March 8, 2022
Completion date March 31, 2023

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