NCT05135481

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

Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 1 Minute – 48 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Ankyloglossia
• Breast Feeding, Exclusive
• Lactation Failure
• Tongue-tie

Interventions

Type	Name	Description
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).
OTHER	Increased lactation support	Management in group 2 will include increased lactation care both during hospital stay and post discharge.

Timeline

• Start date: 2022-03-08
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2021-11-26
• Last updated: 2022-07-21

Locations

1 site across 1 country: Poland