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

NCT05135481 | Withdrawn DMC

• 1 other identifier: FRENO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of exclusively breastfeeding mothers

  Proportion of exclusively breastfeeding mothers

  at 12 weeks of age

Secondary Outcomes (8)

• Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.

  at 12 weeks of age

• Weight change

  at 12 weeks of age

• Head circumference change

  at 12 weeks of age

• Length change

  at 12 weeks of age

• Incidence of using a breast pump or lactation accessories

  at 12 weeks of age

Study Arms (2)

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.

Procedure: phrenectomy

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.

Other: Increased lactation support

Interventions

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).

CONTROL GROUP

Increased lactation support OTHER

Management in group 2 will include increased lactation care both during hospital stay and post discharge.

Also known as: dedicated lactation support

STUDY GROUP

Eligibility Criteria

• Age: 1 Minute - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead
• Medical University of Warsaw: collaborator

Study Sites (1)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, 00-315, Poland

Location

MeSH Terms

Conditions

Ankyloglossia; Breast Feeding

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Feeding Behavior; Behavior

Study Officials

• Joanna Seliga - Siwecka, MD PhD

  Medical University of Warsaw

  STUDY DIRECTOR

• Justyna Fiałkowska, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 26, 2021
• Study Start: March 8, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

PL (1)