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

Not Applicable
Withdrawn
Conditions
Ankyloglossia
Tongue-tie
Breast Feeding, Exclusive
Lactation 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WITHDRAWN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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Proportion of exclusively breastfeeding mothersat 12 weeks of age

Proportion of exclusively breastfeeding mothers

Secondary Outcome Measures
NameTimeMethod
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 changeat 12 weeks of age

Median weight change

Head circumference changeat 12 weeks of age

Median head circumference change

Length changeat 12 weeks of age

Median length change

Change in breastfeeding comfortat 12 weeks of age

Proportion of mothers reporting change in breastfeeding comfort

Time of breastfeeding cessationduring 12 weeks of age

median time of breastfeeding cessation

Incidence of using a breast pump or lactation accessoriesat 12 weeks of age

Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields)

Rate of additional consultationsduring 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

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