van Stigt Marit J B, van Hal Anne-Fleur R L, Bittermann Arnold J N, Butler Colin R, Ceelie Ilse, Cianci Daniela, de Coppi Paolo, Gahm Caroline, Hut Julia E, Joosten Koen F M, Lemmers Petra M A, Mullassery Dhanya, Nandi Reema, Pullens Bas, Staals Lonneke M, Svensson Jan F, Tytgat Stefaan H A J, van de Ven Peter M, Wijnen René M H, Vlot John, Lindeboom Maud Y A
Congenital Oesophageal and Airway Team Utrecht, Departments of Paediatric Surgery and Otorhinolaryngology and Head and Neck Surgery, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands
Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
BMJ Open. 2024 Dec 12;14(12):e087272. doi: 10.1136/bmjopen-2024-087272.
Tracheomalacia (TM) often occurs in children with oesophageal atresia (OA), leading to recurrent respiratory symptoms and in severe cases to blue spells or ultimately respiratory arrest. In some patients, a secondary posterior tracheopexy may then be indicated. This secondary surgery, as well as respiratory morbidity, may be prevented by performing a primary posterior tracheopexy (PPT) concurrent with primary OA correction. The aim of this trial is to determine if a PPT can decrease-or prevent-tracheal collapse in newborns with OA and TM. Additionally, the trial aims to determine whether the potential observed effect of PPT on tracheal stability is sustained over time.
This is an international multicentre double-blind randomised controlled trial. Seventy-eight children with OA type C will be randomised 1:1 into the no-PPT group or PPT group. Randomisation will be stratified by centre. The degree and location of TM are assessed during preoperative, intraoperative and two postoperative tracheobronchoscopies. The occurrence of TM will be evaluated during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages. The difference in the mean degree of collapse will be compared between the no-PPT and the PPT groups using linear regression, adjusting for centre and the preoperative degree of tracheal collapse at baseline. The adjusted mean difference will be reported as effect size together with its 95% CI.
Patients will be included after written parental informed consent. The risks and burden associated with the trial are minimal. The institutional review board of the University Medical Center Utrecht has approved this protocol (METC-number 23-256/A). Results will be shared in a peer-reviewed scientific journal and presented at international conferences.
NCT06335862.
气管软化症（TM）常发生于食管闭锁（OA）患儿，导致反复出现呼吸道症状，严重时可出现青紫发作甚至最终呼吸骤停。部分患者可能需要进行二期后路气管固定术。通过在一期OA矫正术同时进行一期后路气管固定术（PPT），可以预防这种二期手术以及呼吸道并发症。本试验旨在确定PPT能否减少或预防患有OA和TM的新生儿气管塌陷。此外，该试验还旨在确定PPT对气管稳定性的潜在观察效果是否能长期维持。
这是一项国际多中心双盲随机对照试验。78例C型OA患儿将按1:1随机分为非PPT组或PPT组。随机分组将按中心进行分层。在术前、术中和术后两次气管镜检查时评估TM的程度和位置。在6个月龄前的三次常规随访中评估TM的发生情况。主要结局是术中气管镜检查（在进行PPT/非PPT操作后）时气管壁塌陷的程度，以百分比衡量。使用线性回归比较非PPT组和PPT组塌陷平均程度的差异，并对中心和基线时术前气管塌陷程度进行校正。校正后的平均差异将作为效应量及其95%置信区间报告。
在获得家长书面知情同意后纳入患者。与试验相关的风险和负担极小。乌得勒支大学医学中心的机构审查委员会已批准本方案（METC编号23 - 256/A）。结果将在同行评审的科学期刊上发表，并在国际会议上展示。
NCT06335862
