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

NCT05135481 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-21

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of Warsaw

    collaborator OTHER

  • Princess Anna Mazowiecka Hospital, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Joanna Seliga - Siwecka, MD PhD · Medical University of Warsaw

  • Justyna Fiałkowska, MD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2022-12-31
Completion
2023-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135481 on ClinicalTrials.gov