Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04334590 |
| Other study ID # |
IRB00176186 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 8, 2020 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Approximately 7000 babies are born with a cleft lip and/or cleft palate in the United States
per year. Globally, this defect is staggeringly common, with 100,000 new cases per year. This
defect is due to a failure of normal fusion between facial structures, causing a full
thickness gap of the upper lip involving skin, muscle, and other connective tissue. Due to
aberrant insertion of the muscle underlying the lip as well as abnormal formation of deeper
facial structures, the nose is also displaced inferiorly, laterally, and posteriorly. The
wider the cleft, the more challenging the repair.
Current best practice in treating unilateral cleft lip and nose deformity involves
presurgical infant orthopedics (PSIOs). PSIOs involves presurgically treating the deformity
using custom orthodontics to gradually bring the two halves of the cleft together, reducing
defect size and enabling complete repair with one surgery during early infancy. However,
creation of these molds is time consuming and requires the expertise of a cleft orthodontist
and weekly visits to the hospital for device advancement. As not all cleft centers have a
specialized cleft orthodontist-including Johns Hopkins Hospital-many are unable to provide
presurgical infant orthopedics. Weekly travel to cleft centers can also pose a significant
temporal and financial burden to families, as the average patient is located over 60 miles
from the nearest cleft center. In a recent survey of cleft centers in the United States, only
30% of these centers are able to provide presurgical orthopedic molding devices in treatment
protocols. These centers therefore correct wide clefts with a staged, two-surgery approach.
This approach is often less successful in both adequately aligning the gum and in repairing
nasal defects, and usually requires intensive orthodontics and additional surgeries in
adolescence. As the defect is not fully corrected in infancy, children are additionally
subjected to the emotional and psychological difficulty and damage to self-esteem associated
with the persistent defect.
With the advent of 3D printing technology, the investigators are now in the planning stages
of implementing a new clinical protocol to bring PSIOs to Johns Hopkins Hospital (JHH). A
cleft orthodontist at an equipped center will remotely design these orthodontic molds, which
will then be 3D printed using dental acrylic (the same material currently used in
hand-fabricated orthodontic models) and given to patients in the investigators' clinic. As
planning these devices for 3D printing can be done remotely in a fraction of the time it
would take to create each one by hand, this change in clinical practice will eliminate the
need for an in-person specialized craniofacial orthodontist on faculty where one does not
exist.
This research study seeks to elucidate both the investigators' current standard of cleft
practice and the benefits the investigators hope to see after implementing this change in
clinical practice. The investigators expect that although the investigators will initially
create each new mold after a weekly hospital visit with in-person measurements, the
investigators ultimately aim to develop an algorithm to predict early growth and development
of the newborn's facial skeleton and soft tissue. This will allow the fabrication of
sequential pre-surgical orthopedic molding devices based of the infant's predicted facial
growth, which can be delivered en bloc to the infants home, thereby eliminating the need for
frequent visits to geographically inconvenient centers. After 4-5 months of using these
devices, the bony cleft gap will be closed, the nose straightened, and the child be ready for
the definitive cleft lip and nose repair in a single surgery. These devices will not only
physically close the gap of the cleft lip deformity, but will also close the gap in access to
the necessary specialists for the ideal management of cleft deformities across the country.
With this technology, any cleft center can offer naso-alveolar molding to every child born
with cleft lip and palate in the country.
