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

Breast Feeding, Exclusive Clinical Trial

Official title:

Effect of Intensive Lactation Support vs Frenotomy on the Incidence of Breastfeeding in Term Infants: a Randomised Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05135481
• Other study ID #: FRENO
• Status: Withdrawn
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2022
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Ankyloglossia
• Breast Feeding, Exclusive
• Lactation Failure

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Neonatology and Neonatal Intensive Care Warsaw Medical University	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland	Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of exclusively breastfeeding mothers	Proportion of exclusively breastfeeding mothers	at 12 weeks of age
Secondary	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
Secondary	Weight change	Median weight change	at 12 weeks of age
Secondary	Head circumference change	Median head circumference change	at 12 weeks of age
Secondary	Length change	Median length change	at 12 weeks of age
Secondary	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
Secondary	Time of breastfeeding cessation	median time of breastfeeding cessation	during 12 weeks of age
Secondary	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
Secondary	Change in breastfeeding comfort	Proportion of mothers reporting change in breastfeeding comfort	at 12 weeks of age