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

NCT ID: NCT05135481

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2023-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CONTROL GROUP

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.

Group Type: ACTIVE_COMPARATOR

phrenectomy

Intervention Type: 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).

STUDY GROUP

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.

Group Type: EXPERIMENTAL

Increased lactation support

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: PROCEDURE

Increased lactation support

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

Intervention Type: OTHER

Other Intervention Names

dedicated lactation support

Eligibility Criteria

Inclusion Criteria

1. full - term infants born with an Apgar score of 8-10 points

2. no visual causes of lactation difficulties (malocclusion, posterior and small jaw, cervical torticollis, significant positional asymmetry)

3. parental consent

Exclusion Criteria

1. hypotrophy

2. low birth weight

3. perinatal complications

4. congenital craniofacial defects

5. neurological diseases

6. visible genetic syndromes

7. mother' unwilling to breastfeed

8. no consent for vaccination against hepatitis B

9. neonates born to HIV seropositive mothers

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

Princess Anna Mazowiecka Hospital, Warsaw, Poland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Seliga - Siwecka, MD PhD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Justyna Fiałkowska, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, , Poland

Countries

Poland

Other Identifiers

FRENO

Identifier Type: -

Identifier Source: org_study_id