Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)
2017年11月20日 更新者：NYU Langone Health
Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)
The purpose of this prospective, multi-center, longitudinal study is to assess clinical outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular distraction osteogenesis).
This study aims to develop a scoring system to determine success and complication rate pre and post MDO.
研究概览
地位
撤销
条件
详细说明
The recruitment phase of this trial is 3 years. Duration of the trial is 19 years.
All study patients who undergo mandibular distraction will be indicated for surgery following published and accepted protocols of care for mandibular distraction in this specific patient population. There will be no experimental/treatment arms in this study. All patients will undergo standard of care interventions and assessments that would not change if the patient were not to participate in this study. The purpose of this study is to follow multiple surgical outcomes following these standard of care practices. The methods and procedures detailed below follow published and accepted standards of care.
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
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New York、New York、美国、10010
- NYU School of Medicine
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1天 至 6个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This study will include all infants under the age of 6 months who undergo mandibular distraction.
We will include all racial and ethnic groups as well as both genders.
We will not include patients over the age of 6 months.
描述
Inclusion Criteria:
- Signed Informed Consent/Assent Form
- All patients with PRS as defined by mandibular hypoplasia, glossoptosis causing airway obstruction, who undergo MDO prior to the age of 6 months, will be included in the study. This will include all infants regardless of syndromic diagnosis, other organ system abnormalities, cleft palate diagnosis or the presence of other concurrent craniofacial anomalies.
Exclusion Criteria:
- Infants over the age of 6 months
- patients who undergo mandibular distraction for conditions other than Pierre Robin sequence.
- Patient who refuse to be included in this study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Development of Functionality over time
大体时间：Q 6 years
|
We will monitor changes in maxillofacial development, functionality and surgical complications
|
Q 6 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cleft Palate Repair outcome
大体时间：1 year
|
Incidence of airway complications, Incidence of fistula and fistula location
|
1 year
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mandibular growth
大体时间：6 years
|
as measired by PE, panorex and lateral cephalogram
|
6 years
|
|
Long term outcome
大体时间：12 and 18 years
|
change in AHI or additional airway surgery, incidence of TMJ, tooth development, sensation, scar quality, limitation in jaw excursion
|
12 and 18 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Roberto Flores, MD、NYU School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Rachmiel A, Emodi O, Rachmiel D, Aizenbud D. Internal mandibular distraction to relieve airway obstruction in children with severe micrognathia. Int J Oral Maxillofac Surg. 2014 Oct;43(10):1176-81. doi: 10.1016/j.ijom.2014.06.013. Epub 2014 Jul 19.
- Runyan CM, Uribe-Rivera A, Karlea A, Meinzen-Derr J, Rothchild D, Saal H, Hopkin RJ, Gordon CB. Cost analysis of mandibular distraction versus tracheostomy in neonates with Pierre Robin sequence. Otolaryngol Head Neck Surg. 2014 Nov;151(5):811-8. doi: 10.1177/0194599814542759. Epub 2014 Jul 22.
- Cladis F, Kumar A, Grunwaldt L, Otteson T, Ford M, Losee JE. Pierre Robin Sequence: a perioperative review. Anesth Analg. 2014 Aug;119(2):400-412. doi: 10.1213/ANE.0000000000000301.
- Scott AR, Mader NS. Regional variations in the presentation and surgical management of Pierre Robin sequence. Laryngoscope. 2014 Dec;124(12):2818-25. doi: 10.1002/lary.24782. Epub 2014 Jun 26.
- Denny AD. Discussion: The surgical correction of Pierre Robin sequence: mandibular distraction osteogenesis versus tongue-lip adhesion. Plast Reconstr Surg. 2014 Jun;133(6):1443-1444. doi: 10.1097/PRS.0000000000000182. No abstract available.
- Lee JC, Bradley JP. Surgical considerations in pierre robin sequence. Clin Plast Surg. 2014 Apr;41(2):211-7. doi: 10.1016/j.cps.2013.12.007. Epub 2014 Feb 7.
- Murage KP, Tholpady SS, Friel M, Havlik RJ, Flores RL. Outcomes analysis of mandibular distraction osteogenesis for the treatment of Pierre Robin sequence. Plast Reconstr Surg. 2013 Aug;132(2):419-421. doi: 10.1097/PRS.0b013e3182958a54.
- Tahiri Y, Viezel-Mathieu A, Aldekhayel S, Lee J, Gilardino M. The effectiveness of mandibular distraction in improving airway obstruction in the pediatric population. Plast Reconstr Surg. 2014 Mar;133(3):352e-359e. doi: 10.1097/01.prs.0000438049.29258.a8.
- Paes EC, Fouche JJ, Muradin MS, Speleman L, Kon M, Breugem CC. Tracheostomy versus mandibular distraction osteogenesis in infants with Robin sequence: a comparative cost analysis. Br J Oral Maxillofac Surg. 2014 Mar;52(3):223-9. doi: 10.1016/j.bjoms.2013.11.017. Epub 2013 Dec 30.
- Balaraman K, Shanmugakrishnan RR, Bharathi RR, Sabapathy SR. Mandibular distraction in a 75-day-old child with severe Pierre Robin sequence. Indian J Plast Surg. 2013 Jan;46(1):154-6. doi: 10.4103/0970-0358.113743. No abstract available.
- Lam DJ, Tabangin ME, Shikary TA, Uribe-Rivera A, Meinzen-Derr JK, de Alarcon A, Billmire DA, Gordon CB. Outcomes of mandibular distraction osteogenesis in the treatment of severe micrognathia. JAMA Otolaryngol Head Neck Surg. 2014 Apr;140(4):338-45. doi: 10.1001/jamaoto.2014.16.
- Collins B, Powitzky R, Robledo C, Rose C, Glade R. Airway management in pierre robin sequence: patterns of practice. Cleft Palate Craniofac J. 2014 May;51(3):283-9. doi: 10.1597/12-214. Epub 2013 Jul 22.
- Schoemann MB, Burstein FD, Bakthavachalam S, Williams JK. Immediate mandibular distraction in mandibular hypoplasia and upper airway obstruction. J Craniofac Surg. 2012 Nov;23(7 Suppl 1):1981-4. doi: 10.1097/SCS.0b013e31825a64d9.
- Cicchetti R, Cascone P, Caresta E, Papoff P, Miano S, Cerasaro C, Ramieri V, Midulla F, Moretti C. Mandibular distraction osteogenesis for neonates with Pierre Robin sequence and airway obstruction. J Matern Fetal Neonatal Med. 2012 Oct;25 Suppl 4:141-3. doi: 10.3109/14767058.2012.715011.
- Scott AR, Tibesar RJ, Sidman JD. Pierre Robin Sequence: evaluation, management, indications for surgery, and pitfalls. Otolaryngol Clin North Am. 2012 Jun;45(3):695-710, ix. doi: 10.1016/j.otc.2012.03.007.
- Sesenna E, Magri AS, Magnani C, Brevi BC, Anghinoni ML. Mandibular distraction in neonates: indications, technique, results. Ital J Pediatr. 2012 Feb 2;38:7. doi: 10.1186/1824-7288-38-7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (实际的)
2017年10月27日
研究完成 (实际的)
2017年10月27日
研究注册日期
首次提交
2015年4月10日
首先提交符合 QC 标准的
2015年4月28日
首次发布 (估计)
2015年5月4日
研究记录更新
最后更新发布 (实际的)
2017年11月22日
上次提交的符合 QC 标准的更新
2017年11月20日
最后验证
2017年11月1日
更多信息
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