Ankyloglossia and Breastfeeding
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 72
SponsorAriana Muñoz San Miguel
About this trial
Ankyloglossia is a congenital condition characterized by a restrictive lingual frenulum that may limit normal tongue mobility and be associated with breastfeeding difficulties. Reported problems include ineffective latch, maternal nipple pain and nipple trauma, mastitis, reduced milk transfer, poor infant weight gain, and early breastfeeding cessation. However, the available evidence regarding the impact of ankyloglossia on breastfeeding outcomes remains limited and controversial.
The primary objective of this prospective cohort study is to evaluate the association between neonatal ankyloglossia, assessed using the TABBY assessment tool during the first 72 hours of life, and breastfeeding effectiveness measured using the LATCH scale during the same period.
Mother-infant dyads will be recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth, at the University Hospital of Guadalajara, Spain. Newborns will be classified according to the presence or absence of ankyloglossia using the TABBY assessment tool and will be followed for the first 6 months of life. Information will be collected during routine clinical follow-up and through telephone interviews.
The secondary objectives are to evaluate the association between ankyloglossia and breastfeeding duration, exclusive breastfeeding duration, maternal pain during breastfeeding, and maternal breastfeeding satisfaction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mother-infant dyads recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara.
Singleton pregnancy.
Gestational age at birth between 37 weeks and 41 weeks and 6 days.
Maternal intention to provide exclusive or mixed breastfeeding.
Disqualifiers
Birth outside the University Hospital of Guadalajara.
Preterm birth (<37 weeks of gestation).
Fetal or neonatal pathology diagnosed before or after birth.
Admission to the neonatal unit after birth or during the hospital stay.
Trial population
The study population will consist of mother-infant dyads recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara (Spain). Eligible newborns will be healthy, singleton, term infants (37 weeks to 41 weeks and 6 days of gestation). Participants will be classified according to the presence or absence of ankyloglossia based on the TABBY assessment tool and followed for 6 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TABBY
Diagnostic testTABBY ≤ 5
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Newborn with ankyloglossia1 intervention
Group B: Newborn without ankyloglossia0 interventions
Trial outcomes
Primary outcomes
1
Beastfeeding effectiveness
Breastfeeding effectiveness assessed using the LATCH scale. LATCH (Latch, Audible swallowing, Type of nipple, Comfort, Hold).Breastfeeding effectiveness will be assessed using the LATCH scale. The scale evaluates five components: latch, audible swallowing, type of nipple, maternal breast and nipple comfort, and positioning assistance. Each component is scored from 0 to 2, giving a total score from 0 to 10. Higher scores indicate more effective breastfeeding
Time frame
During the first 72 hours of life.Secondary outcomes
1
Duration of exclusive breastfeeding assessed by maternal telephone interview
Duration of exclusive breastfeeding will be determined through maternal telephone interviews conducted at 4 and 6 months. It will be measured as the time from birth until the introduction of infant formula, other liquids, or complementary foods.
Time frame
From birth to 6 months of age2
Duration of any breastfeeding assessed by maternal telephone interview
Duration of any breastfeeding will be determined through maternal telephone interviews conducted at 4 and 6 months. It will be measured as the time from birth until complete cessation of breastfeeding, regardless of the introduction of infant formula, other liquids, or complementary foods.
Time frame
From birth to 6 months of age3
Maternal nipple pain assessed using the Numerical Rating Scale (NRS)
Maternal nipple pain during breastfeeding will be assessed using the Numerical Rating Scale (NRS). Mothers will rate their pain from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame
During the first 72 hours after birth and at 5-15 days4
Breastfeeding outcomes after frenotomy assessed using the LATCH scale and maternal follow-up interviews
Among infants with ankyloglossia, breastfeeding outcomes will be compared between those who undergo frenotomy as part of routine clinical care and those who do not. Outcomes will include duration of any breastfeeding, duration of exclusive breastfeeding, maternal pain during breastfeeding, and maternal satisfaction with breastfeeding measured on a numerical rating scale from 0 to 5. Data will be collected through scheduled maternal follow-up interviews. The study will not assign frenotomy.
Time frame
From birth through 6 months of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ariana Muñoz San Miguel
Lead sponsor
University of Alcala
Sponsor institution
Source ClinicalTrials.gov
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