Fabrication of Sequential Naso-Alveolar Molding Appliances in the Treatment of Cleft Lip/Nose Deformities

NCT04334590 | Withdrawn

• 1 other identifier: IRB00176186
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

There is a robust body of research suggesting that the use of pre-surgical orthopedic devices prior to definitive cleft lip/nose repair results in significant improvement of facial aesthetics with long term follow up. However, in recent surveys of the cleft centers in the US, only 30% of cleft centers offer PSIOs, and only 13% routinely report its use. Accordingly, thirty percent of centers utilize a two-stage cleft lip/nose repair in the centers' algorithm (1st: lip adhesion; 2nd: final lip repair). The major drawback to a two-stage cleft procedure is the administration of two general anesthetics to an infant before the age of one year. There is a growing amount of evidence that multiple anesthetic experiences before a certain age could affect brain development. It is difficult to make inferences as to why clinicians are not utilizing surgical aids to decrease the size of the cleft width, but even when PSIO is offered, caregivers experience additional, potentially prohibitive challenges. In one study, caregivers traveled an average of 70 miles to visit the nearest cleft center offering pre-surgical orthopedic devices. As these devices are created by hand every 1-2 weeks after seeing the child in clinic, parents are required to travel to clinic multiple times per month. Not surprisingly, infants who were first-born and those who did not have other siblings were more likely to receive pre-surgical orthopedic treatment than infants who were residing with other siblings. Given the benefits of PSIOs and the barriers both to healthcare systems and patients' families associated with PSIOs in its current form, a new form of pre-surgical clinical management is needed. Objectives:

1. 1.Evaluate JHH's current clinical performance in addressing unilateral cleft lip and nasal deformity.
2. 2.Elucidate the difference in preoperative cleft size and in surgical management/outcomes for patients who received PSIOs through 3D-printed devices.
3. 3.Using the above maxillofacial growth data with and without PSIOs, the investigators aim to create an algorithm to predict maxillofacial growth for each individual patient to design pre-sequenced custom PSIO devices.

Conditions

Cleft Lip; Congenital Nose Malformation; Deformity; Nose Deformities, Acquired

Keywords

Cleft Lip

Outcome Measures

Primary Outcomes (3)

• Percentage of cleft patients with an alveolar cleft of <5 mm at time of the first surgery

  Percentage of cleft patients with an alveolar cleft of \<5 mm at time of the first surgery will be assessed to determine the effect of 3D printed orthognathic pre-surgical molding devices on cleft care.

  At the time of first surgery (3 months)

• Cleft size at initial clinic presentation

  Cleft size in millimeters (mm) at initial clinic presentation.

  At the time of initial clinic visit up to 1 hour

• Size of cleft at pre- and post-operative clinic visit

  Size of cleft in millimeters at pre- and post-operative clinic visit

  At pre- and post-operative clinic visit, up to 4 months

Secondary Outcomes (4)

• Rate of change in cleft size

  Weekly, up 8 weeks

• Length of time to achieve a cleft <5 mm

  Up to 4 months

• Aesthetic outcome following cleft surgical repair as assessed by the surgeon

  Post surgery, up to 4 months

• Satisfaction with the 3-D printed pre-surgical orthopedic device as assessed by parents

  Post surgery, up to 4 months

Study Arms (2)

Cleft Lip/Nose Repair without PSIO

Participants who will undergo cleft lip/nose repair prior to addition of PSIO as part of standard of care in Hopkins.

Procedure: Cleft Lip/Nose Repair without PSIO

Presurgical Infant Orthopedic Therapy

Participants who will undergo cleft lip/nose repair after addition of PSIO as part of standard of care in Hopkins.

Procedure: Presurgical Infant Orthopedic Therapy

Interventions

Cleft Lip/Nose Repair without PSIO PROCEDURE

Standard of care surgical repair of cleft lip/nose without PSIO.

Cleft Lip/Nose Repair without PSIO

Presurgical Infant Orthopedic Therapy PROCEDURE

Standard of care surgical repair of cleft lip/nose with PSIO.

Presurgical Infant Orthopedic Therapy

Eligibility Criteria

• Age: 0 Months - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns either born in Johns Hopkins or presenting to clinic with a cleft lip between 0-1 months of life.

You may qualify if:

• All newborns either born in Johns Hopkins or presenting to clinic with a cleft lip between 0-1 months of life

You may not qualify if:

• Patients older than one month of age at presentation

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cleft Lip; Congenital Abnormalities; Nose Deformities, Acquired

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Richard Redett

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: June 8, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)