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

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Status: Withdrawn

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

Treatments: Procedure: phrenectomy; Other: Increased lactation support

Study type: Interventional

Funder types: Other

Identifiers

NCT05135481

FRENO

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 minute to 48 hours old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CONTROL GROUP

Active Comparator group

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.

Treatment:

Procedure: phrenectomy

STUDY GROUP

Experimental group

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.

Treatment:

Other: Increased lactation support