Pierre Robin Sequence Outcome Assessment Multi Institutional Study

Pierre Robin Sequence Clinical Trial

— PROMIS  

Official title:

Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02432638
• Other study ID #: 14-01966
• Status: Withdrawn
• Phase: N/A
• First received: April 10, 2015
• Last updated: November 20, 2017
• Start date: April 2015
• Est. completion date: October 27, 2017

Study information

• Verified date: November 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

1. Signed Informed Consent/Assent Form

2. 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:

1. Infants over the age of 6 months

2. patients who undergo mandibular distraction for conditions other than Pierre Robin sequence.

3. Patient who refuse to be included in this study

Related Conditions & MeSH terms

• Pierre Robin Sequence
• Pierre Robin Syndrome

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
New York University School of Medicine	Indiana University, University of California, Los Angeles, University of Southern California, University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. Review. — View Citation

Cladis F, Kumar A, Grunwaldt L, Otteson T, Ford M, Losee JE. Pierre Robin Sequence: a perioperative review. Anesth Analg. 2014 Aug;119(2):400-12. doi: 10.1213/ANE.0000000000000301. Review. — View Citation

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. — View Citation

Denny AD. Discussion: The surgical correction of Pierre Robin sequence: mandibular distraction osteogenesis versus tongue-lip adhesion. Plast Reconstr Surg. 2014 Jun;133(6):1443-4. doi: 10.1097/PRS.0000000000000182. — View Citation

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. — View Citation

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. Review. — View Citation

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):419-21. doi: 10.1097/PRS.0b013e3182958a54. — View Citation

Paes EC, Fouché 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mandibular growth	as measired by PE, panorex and lateral cephalogram	6 years
Other	Long term outcome	change in AHI or additional airway surgery, incidence of TMJ, tooth development, sensation, scar quality, limitation in jaw excursion	12 and 18 years
Primary	Development of Functionality over time	We will monitor changes in maxillofacial development, functionality and surgical complications	Q 6 years
Secondary	Cleft Palate Repair outcome	Incidence of airway complications, Incidence of fistula and fistula location	1 year