Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief … (NCT02141243) | Clinical Trial Compass
CompletedNot Applicable
Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
United States120 participantsStarted 2015-05
Plain-language summary
We are proposing to conduct a randomized, controlled trial of newborns in the maternal infant care areas at Tampa General Hospital. Participants who are determined eligible for the study (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for intervention #2. Group B will receive a lingual frenotomy procedure for intervention #1 and a sham procedure for intervention #2. Newborns that continue to have difficulty with breastfeeding after both interventions will undergo intervention #3, a labial frenotomy, and breastfeeding will be monitored afterwards.
Who can participate
Age range2 Weeks
SexALL
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Inclusion criteria
✓. Newborn is full term (at least 37 weeks) and otherwise in good health.
✓. Newborn exhibits having ankyloglossia (score of less than 11 with failing lactation management or an appearance score lower than 8, based on HATLFF) and a Class III or Class IV maxillary lip-tie, simultaneously.
✓. Mother of newborn noted to have nipple pain or difficulty with breastfeeding (LATCH score of \<7).
✓. Mother of newborn has intention to exclusively breastfeed newborn.
✓. Mother of newborn signs a written informed consent for treatment.
Exclusion criteria
✕. Premature newborns.
✕. Newborns older than 2 weeks.
✕. Newborns with craniofacial anomalies (i.e. cleft lip or palate).
✕. Newborns who are neurologically compromised.
✕. Mother has condition that could affect the milk supply (i.e diabetes).
What they're measuring
1
Change in Wong-Baker FACES Pain Rating Scale
Timeframe: after breastfeeding before intervention #1, after breastfeeding after intervention #1, after breastfeeding after intervention #2, and during 1 week follow-up (also after intervention #3 if applicable)
2
Change in LATCH score
Timeframe: after breastfeeding before intervention #1, after breastfeeding after intervention #1, after breastfeeding after intervention #2, and during 1 week follow-up (also after intervention #3 if applicable)