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. 2024 Jul 4;25(1):453.
doi: 10.1186/s13063-024-08229-z.

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

Badri Thiruvenkatachari  1 , Krishnamurthy Bonanthaya  2 , Anne Marie Kuijpers Jagtman  3   4 , Jonathan Sandler  5 , Rajesh S Powar  6 , Syed Altaf Hussain  7 , B Subramaniyan  7 , Nitin Bhola  8 , Hari Kishore Bhat  9 , Varun Ramachandra  10 , Sylvia Jayakumar  11 , Puneet Batra  12 , Subhiksha Chakkaravarthi  13 , V Thailavathy  13 , Manoj Prathap  13 , Thulasiram Elumalai  13 , Karthika Nambiar  13 , Charanya Vijayakumar  7 , Ravi Kumar Mahajan  14 , Sundereshwer Chander Sood  15 , Sukhdeep Singh Kahlon  14 , Shruti Bijapur  2 , Ranjit Haridas Kamble  8 , K M Keluskar  16 , Amit Nilgar  16 , Faizan Ahmed Khan  9 , Devika Das  10 , Swetha Sridhar  7 , Adrija Buch  10 , Shuba Kumar  17 , Rani Mohanraj  17 , Stefan Listl  18 , Samiksha Chopra  14 , Vikrant Jadhav  8 , Anika Arora  12 , Chintan Valiya  10 , Madhuri Pattamata  19
Affiliations

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

Badri Thiruvenkatachari et al. Trials. .

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 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 USA 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-centre, 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 the 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 the 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: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. 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).

Keywords: CLP; Cleft lip and palate; NAM treatment; Nasoalveolar moulding; PSIO; Presurgical infant orthopaedics; Randomized controlled trials.

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Conflict of interest statement

None of the authors or study members have any conflicts of interest. Dr. Pedro Santiago and Dr. Barry Grayson conduct courses to promote the NAM technique but do not receive any other financial benefits. Both clinicians will be involved in the calibration exercise and in training the study investigators on the clinical treatment protocol. However, they will not be involved in the study’s methodology, execution or dissemination.

Figures

Fig. 1
Fig. 1
Schematics of trial design
Fig. 2
Fig. 2
Nasoalveolar moulding appliance in situ with a nasal stent to lift the cleft-sided nostril upward and forward
Fig. 3
Fig. 3
SPIRIT figure
Fig. 4
Fig. 4
The schedule of eligibility screening, enrollment, group allocation, visits, interventions and assessments
Fig. 5
Fig. 5
Flowchart for adverse event reporting
See this image and copyright information in PMC

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