A multi-centric, single blinded, randomized, parallel group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus, and palate (NAMUC study). A study protocol for a randomized controlled trial.

Abstract

Background: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve the nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the US and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long term clinical trials available on the effectiveness of this treatment. Method: The NAMUC study is an investigator initiated, multi-center, single blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against no treatment control group in 274 patients with non syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. Discussion: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. Trial Registration number: CTRI/2022/11/047426 (Clinical Trials Registry India) CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: (https://ctri.nic.in/Clinicaltrials/advsearch.php - use the search boxes by entering the following details: Interventional trial>November 2022>NAMUC)