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recruitment problems
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| Name | Class |
|---|---|
| Medical University of Warsaw | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL GROUP | Active Comparator | 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. |
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| STUDY GROUP | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phrenectomy | Procedure | 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of exclusively breastfeeding mothers | Proportion of exclusively breastfeeding mothers | at 12 weeks of age |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of mother-baby dyads with a breastfeeding frequency of > 50%. | 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] | at 12 weeks of age |
| Weight change |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Seliga - Siwecka, MD PhD | Medical University of Warsaw | Study Director |
| Justyna Fiałkowska, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Warsaw | 00-315 | Poland |
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| ID | Term |
|---|---|
| D000072676 | Ankyloglossia |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Increased lactation support | Other | Management in group 2 will include increased lactation care both during hospital stay and post discharge. |
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|
Median weight change |
| at 12 weeks of age |
| Head circumference change | Median head circumference change | at 12 weeks of age |
| Length change | Median length change | at 12 weeks of age |
| Incidence of using a breast pump or lactation accessories | Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields) | at 12 weeks of age |
| Time of breastfeeding cessation | median time of breastfeeding cessation | during 12 weeks of age |
| Rate of additional consultations | Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads. | during 12 weeks of age |
| Change in breastfeeding comfort | Proportion of mothers reporting change in breastfeeding comfort | at 12 weeks of age |