Ankyloglossia, Breast Feeding, Exclusive, Lactation Failure, Tongue-tie
Conditions
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.
Interventions
PROCEDUREphrenectomy
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).
OTHERIncreased lactation support
Management in group 2 will include increased lactation care both during hospital stay and post discharge.
Sponsors
Medical University of Warsaw
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 48 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of exclusively breastfeeding mothers | at 12 weeks of age | Proportion of exclusively breastfeeding mothers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 \[9, 10\] |
| Time of breastfeeding cessation | during 12 weeks of age | median time of breastfeeding cessation |
| 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. |
| Change in breastfeeding comfort | at 12 weeks of age | Proportion of mothers reporting change in breastfeeding comfort |
| 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) |
Countries
Poland
Outcome results
None listed