Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CONTROL GROUP 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. |
Procedure: phrenectomy
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).
|
| Experimental: STUDY GROUP Management in group 2 will include increased lactation care both during hospital stay and post discharge. Increased lactation care will consist of: individual consultations on how to properly attach the baby to the breast (at least 3 meetings during hospitalization with personnel trained in lactation counselling), regular (at least once a week) contact with a breastfeeding consultant as part of a closed group on social media or by phone, if necessary (expressed by the mother or based on a referral by a member of the lactation team) an outpatient appointment at the breastfeeding clinic. |
Other: Increased lactation support
Management in group 2 will include increased lactation care both during hospital stay and post discharge.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of exclusively breastfeeding mothers [at 12 weeks of age]
Proportion of exclusively breastfeeding mothers
Secondary Outcome Measures
- 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
- 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)
- 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
Eligibility Criteria
Criteria
Inclusion criteria:
-
full - term infants born with an Apgar score of 8-10 points
-
no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)
-
parental consent
Exclusion criteria:
-
hypotrophy
-
low birth weight
-
perinatal complications
-
congenital craniofacial defects
-
neurological diseases
-
visible genetic syndromes
-
mother' unwilling to breastfeed
-
no consent for vaccination against hepatitis B
-
neonates born to HIV seropositive mothers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Warsaw | Poland | 00-315 |
Sponsors and Collaborators
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Medical University of Warsaw
Investigators
- Study Director: Joanna Seliga - Siwecka, MD PhD, Medical University of Warsaw
- Principal Investigator: Justyna Fiałkowska, MD, Medical University of Warsaw
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FRENO