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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 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 120 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02141243
The ClinicalTrials.gov registry entry for NCT02141243 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT02141243 reports 0 study locations.
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.
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