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NCT02141243 · ClinicalTrials.gov registry record · NA
Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
A NA study, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT02141243: Completed NA study, sponsored by University of South Florida.
NCT02141243 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02141243, a NA study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
This visual pain analog scale is used to measure breastfeeding pain experienced by the mother.
Interventions
- PROCEDURE Sham Procedure
- PROCEDURE Lingual Frenotomy
- PROCEDURE Labial Frenotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-05 |
| Phase | NA |
What the finished NCT02141243 record still lists
NCT02141243 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT02141243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02141243 about?
NCT02141243 is a clinical study titled "Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.". 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 ra...
What is the current status of trial NCT02141243?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2015-05. Estimated completion is 2018-05.
What interventions are being tested in trial NCT02141243?
The interventions under investigation include: Sham Procedure (PROCEDURE), Lingual Frenotomy (PROCEDURE), Labial Frenotomy (PROCEDURE).
Who is sponsoring clinical trial NCT02141243?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02141243's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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