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

NCT04334590 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-08-21

No results posted yet for this study

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. Evaluate JHH's current clinical performance in addressing unilateral cleft lip and nasal deformity.
2. Elucidate the difference in preoperative cleft size and in surgical management/outcomes for patients who received PSIOs through 3D-printed devices.
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

Interventions

PROCEDURE

Cleft Lip/Nose Repair without PSIO

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

PROCEDURE

Presurgical Infant Orthopedic Therapy

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

Sponsors & Collaborators

Principal Investigators

  • Richard Redett · Johns Hopkins University

Eligibility

Min Age
0 Months
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334590 on ClinicalTrials.gov