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

Not Applicable

Withdrawn

• Conditions: Ankyloglossia; Tongue-tie; Breast Feeding, Exclusive; Lactation Failure
• Interventions: Procedure: phrenectomy; Other: Increased lactation support

• 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.

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-11-26
• Study Start: 2022-03-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
CONTROL GROUP	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.
STUDY GROUP	Increased lactation support	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.

Primary Outcome Measures

Name	Time	Method
Proportion of exclusively breastfeeding mothers	at 12 weeks of age	Proportion of exclusively breastfeeding mothers

Secondary Outcome Measures

Name	Time	Method
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
Change in breastfeeding comfort	at 12 weeks of age	Proportion of mothers reporting change in breastfeeding comfort
Time of breastfeeding cessation	during 12 weeks of age	median time of breastfeeding cessation
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)
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.

Trial Locations

Locations (1)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University; 🇵🇱 Warsaw, Poland