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

Primary Purpose

Ankyloglossia, Breast Feeding, Exclusive, Lactation Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
phrenectomy
Increased lactation support
Sponsored by
Princess Anna Mazowiecka Hospital, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ankyloglossia

Eligibility Criteria

1 Minute - 48 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CONTROL GROUP

STUDY GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of exclusively breastfeeding mothers
Proportion of exclusively breastfeeding mothers

Secondary Outcome Measures

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]
Weight change
Median weight change
Head circumference change
Median head circumference change
Length change
Median length change
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)
Time of breastfeeding cessation
median time of breastfeeding cessation
Rate of additional consultations
Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads.
Change in breastfeeding comfort
Proportion of mothers reporting change in breastfeeding comfort

Full Information

First Posted
November 1, 2021
Last Updated
July 18, 2022
Sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Collaborators
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05135481
Brief Title
Dedicated Lactation Support in Infants With Tongue - Tie; a Randomised Control Trial
Official Title
Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
recruitment problems
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Collaborators
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankyloglossia, Breast Feeding, Exclusive, Lactation Failure, Tongue-tie

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
STUDY GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
phrenectomy
Intervention Description
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
Other
Intervention Name(s)
Increased lactation support
Other Intervention Name(s)
dedicated lactation support
Intervention Description
Management in group 2 will include increased lactation care both during hospital stay and post discharge.
Primary Outcome Measure Information:
Title
Proportion of exclusively breastfeeding mothers
Description
Proportion of exclusively breastfeeding mothers
Time Frame
at 12 weeks of age
Secondary Outcome Measure Information:
Title
Proportion of mother-baby dyads with a breastfeeding frequency of > 50%.
Description
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]
Time Frame
at 12 weeks of age
Title
Weight change
Description
Median weight change
Time Frame
at 12 weeks of age
Title
Head circumference change
Description
Median head circumference change
Time Frame
at 12 weeks of age
Title
Length change
Description
Median length change
Time Frame
at 12 weeks of age
Title
Incidence of using a breast pump or lactation accessories
Description
Proportion of mothers needing to use a breast pump or lactation accessories (e.g. nipple shields)
Time Frame
at 12 weeks of age
Title
Time of breastfeeding cessation
Description
median time of breastfeeding cessation
Time Frame
during 12 weeks of age
Title
Rate of additional consultations
Description
Rate of consultations (e.g. speech therapist, rehabilitants, other lactation consultants) received by a mother - baby dyads.
Time Frame
during 12 weeks of age
Title
Change in breastfeeding comfort
Description
Proportion of mothers reporting change in breastfeeding comfort
Time Frame
at 12 weeks of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Seliga - Siwecka, MD PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Justyna Fiałkowska, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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