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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Feeding, Exclusive; Ankyloglossia; Lactation Failure; Tongue-tie
• Intervention / Treatment: Procedure: phrenectomy; Other: Increased lactation support

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 00-315
    • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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).
EXPERIMENTAL: 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.	Other: Increased lactation support; Management in group 2 will include increased lactation care both during hospital stay and post discharge.; Other Names: dedicated lactation support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of exclusively breastfeeding mothers	Proportion of exclusively breastfeeding mothers	at 12 weeks of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.	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]	at 12 weeks of age
Weight change	Median weight change	at 12 weeks of age
Head circumference change	Median head circumference change	at 12 weeks of age
Length change	Median length change	at 12 weeks of age
Incidence of using a breast pump or lactation accessories	Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields)	at 12 weeks of age
Time of breastfeeding cessation	median time of breastfeeding cessation	during 12 weeks of age
Rate of additional consultations	Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads.	during 12 weeks of age
Change in breastfeeding comfort	Proportion of mothers reporting change in breastfeeding comfort	at 12 weeks of age

Collaborators and Investigators

• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Collaborators: Medical University of Warsaw
• Investigators: Study Director: Joanna Seliga - Siwecka, MD PhD, Medical University of Warsaw; Principal Investigator: Justyna Fiałkowska, MD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (ACTUAL): November 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Ankyloglossia
• Other Study ID Numbers: FRENO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No