Clinical trial NCT05135481: Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial
Official title: Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankyloglossia
Breast Feeding, Exclusive
Lactation Failure
Tongue-tie
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
First posted: 2021-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria:

1. full - term infants born with an Apgar score of 8-10 points
2. no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)
3. parental consent

Exclusion criteria:

1. hypotrophy
2. low birth weight
3. perinatal complications
4. congenital craniofacial defects
5. neurological diseases
6. visible genetic syndromes
7. mother' unwilling to breastfeed
8. no consent for vaccination against hepatitis B
9. neonates born to HIV seropositive mothers

Primary outcomes:
measure: Proportion of exclusively breastfeeding mothers
timeFrame: at 12 weeks of age
Secondary outcomes:
measure: Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.
timeFrame: at 12 weeks of age
measure: Weight change
timeFrame: at 12 weeks of age
measure: Head circumference change
timeFrame: at 12 weeks of age
measure: Length change
timeFrame: at 12 weeks of age
measure: Incidence of using a breast pump or lactation accessories
timeFrame: at 12 weeks of age
measure: Time of breastfeeding cessation
timeFrame: during 12 weeks of age
measure: Rate of additional consultations
timeFrame: during 12 weeks of age
measure: Change in breastfeeding comfort
timeFrame: at 12 weeks of age
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Study officials:
affiliation: Medical University of Warsaw
name: Joanna Seliga - Siwecka, MD PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Warsaw
name: Justyna Fiałkowska, MD
role: PRINCIPAL_INVESTIGATOR
References: