Pierre Robin SequencePROMISNCT02432638
Pierre Robin Sequence Outcome Assessment Multi Institutional Study
An observational study of Pierre Robin Sequence, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Pierre Robin Sequence
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 27 Oct 2017
- How long will I take part?
- 19 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Pierre Robin Sequence
- Medical subject headings
- Pierre Robin Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Functionality over time
We will monitor changes in maxillofacial development, functionality and surgical complications
Measured: Q 6 years
Secondary outcomes (1)
Cleft Palate Repair outcome
Incidence of airway complications, Incidence of fistula and fistula location
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Why it stopped: PI left institution prior to enrollment of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pierre Robin SequenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 19 Years
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Texas, University of California, Los Angeles, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Roberto Flores, MD, Study chair, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432638
- Sponsor's protocol ID
- 14-01966
- Acronym
- PROMIS
- Status last verified
- Nov 2017
- First submitted
- 10 Apr 2015
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25052572Runyan 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.
PubMed 25052512Cladis 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.
PubMed 25046788Scott 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.
PubMed 24965828Denny 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.
PubMed 24867726Lee 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.
PubMed 24607189Murage 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.
PubMed 23897339Tahiri 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.
PubMed 24572880Paes 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.
PubMed 24388657Balaraman 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.
PubMed 23960331Lam 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.
PubMed 24577483Collins 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.
PubMed 23875767Schoemann 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.
PubMed 23154361Cicchetti 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.
PubMed 22958047Scott 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.
PubMed 22588044
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)
- ClinicalTrials.gov ID
- NCT02432638
- Acronym / sponsor ID
- PROMIS / 14-01966
- Conditions
- Pierre Robin Sequence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left institution prior to enrollment of subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Indiana University, University of Texas, University of California, Los Angeles, University of Southern California
- Study start
- Apr 2015
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 19 Years
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of Functionality over time
Time frame: Q 6 years
We will monitor changes in maxillofacial development, functionality and surgical complications
1 secondary outcome
Cleft Palate Repair outcome
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Background: PubMed 25052572Rachmiel 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.
- Background: PubMed 25052512Runyan 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.
- Background: PubMed 25046788Cladis 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.
- Background: PubMed 24965828Scott 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.
- Background: PubMed 24867726Denny 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.
- Background: PubMed 24607189Lee 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.
- Background: PubMed 23897339Murage 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.
- Background: PubMed 24572880Tahiri 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.
- Background: PubMed 24388657Paes 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.
- Background: PubMed 23960331Balaraman 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.
- Background: PubMed 24577483Lam 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.
- Background: PubMed 23875767Collins 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.
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Pierre Robin Sequence (PRS), Difficult Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Flores, MD study chair
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pierre Robin Sequence, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Functionality over time (time frame: Q 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432638, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.