背景:唇腭裂(CLP)是最常见的先天性异常之一,每年在印度影响多达33,000名新生儿。鼻肺泡成型(NAM)是一种在0至6个月大之间进行的非手术治疗,以减少唇裂并改善嘴唇手术前的鼻美学。NAM治疗一直是一个有争议的治疗选择,在欧洲有51%的裂隙队,美国37%的团队和印度25个裂隙团队采用这种方法。这种治疗增加了这些患者已经存在的高护理负担。此外,该技术的支持证据有限,目前尚无关于该治疗有效性的高质量长期临床试验.
方法:NAMUC研究是研究者发起的,多中心,采用平行组设计的单盲随机对照试验。该研究将比较274例非综合征性单侧完全性唇腭裂患者在唇手术前提供的NAM治疗与无治疗对照组的有效性。试验的主要终点是5岁时使用AsherMcDade指数测量的鼻唇美学。次要结果包括牙面发育,演讲,听力,成本效益,生活质量,患者感知,喂养和无形的好处。随机化将通过中央在线系统进行,并根据裂隙宽度进行分层,出生体重和临床试验地点。
结论:我们希望这项关于NAM矫治器长期治疗效果的研究结果以及成本效益评估可以消除全球临床护理的困境和差异。
背景:ClinicalTrials.govCTRI/2022/11/047426(印度临床试验注册中心)。2022年11月18日注册。首例患者于2022年12月11日招募。CTR印度不接受谷歌搜索只是试用号码。必须执行以下步骤才能恢复。如何搜索:(https://ctri。nic.在/临床试验/advsearch。php-通过输入以下详细信息使用搜索框:介入试验>2022年11月>NAMUC)。
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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: 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).