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Набор скоро начнётся NCT07687537

Cleft Lip and Palate Treatment Outcomes Study

— Наблюдательное Cleft Lip and Palate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cleft Lip and Palate. Базовые параметры: 1 Day — 12 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Outcomes of Individualized Presurgical Infant Orthopedic Treatment Approaches in Infants With Cleft Lip and Palate

Обзор

Infants with cleft lip and palate often benefit from presurgical infant orthopedic treatment before surgical repair. Multiple standard of care approaches are selected based on each infant's clinical presentation and family circumstances. This prospective observational cohort study will evaluate clinical outcomes, treatment efficiency, and family burden using routinely collected clinical records and photographs to support individualized, evidence-based PSIO treatment planning.

Подробное описание

Presurgical infant orthopedic (PSIO) treatment is widely used to improve alveolar alignment, nasal symmetry, and soft tissue relationships before primary repair in infants with cleft lip and palate. Standard of care approaches include lip taping, nasoalveolar molding (NAM), and other prefabricated systems. Treatment selection is individualized according to each infant's clinical presentation and family circumstances rather than randomly assigned.

Although PSIO is widely practiced, limited prospective evidence compares the clinical outcomes of individualized standard of care treatment approaches in real-world clinical practice. This prospective observational cohort study will evaluate the clinical outcomes of individualized PSIO treatment provided as part of routine clinical care at the University of Florida College of Dentistry. Infants with cleft lip and palate will be prospectively enrolled and will receive lip taping, NAM, or prefabricated appliance, or no presurgical intervention according to clinical indications and family-specific factors. No investigational drugs, investigational devices, or research-only procedures will be used. Clinical outcomes, including alveolar alignment, cleft gap reduction, nasal symmetry, treatment efficiency, and family treatment burden, will be assessed using routinely collected clinical records, photographs, and treatment data. The findings will provide evidence to support individualized, evidence-based treatment planning for PSIO care.

Первичные конечные точки

  • Change in alveolar segment alignment [Срок оценки: Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months).]
  • Change in nasal symmetry [Срок оценки: Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months).]
  • Treatment completion [Срок оценки: At primary lip repair (approximately 3-5 months after initiation of PSIO).]
Вторичные конечные точки (5)
  • Number of clinic visits during PSIO treatment [Срок оценки: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
  • Duration of PSIO treatment [Срок оценки: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
  • Number of appliance modifications [Срок оценки: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
  • Caregiver compliance [Срок оценки: Initial visiting date to primary lip repair (approximately 3-5 months)]
  • Number of treatment-related adverse events [Срок оценки: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]

Критерии участия

Критерии включения

  • Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment
  • Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair
  • Parent or guardian ability to provide consent
  • Willingness to comply with follow up visits to the extent feasible given family circumstances

Критерии исключения

  • Other craniofacial syndromes requiring a substantially different management protocol
  • Anticipated inability to complete any follow up
  • Lack of parental consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Perez Rivera LR, Tanikawa DYS, Chong DK, Flores RL, Shetye PR. A Comparative Assessment of Surgeon Appraisal of Presurgical Infant Orthopedics Outcomes Using PLANA and NAM. J Craniofac Surg. 2026 Jul-Aug 01;37(7-8):2128-2132. doi: 10.1097/SCS.0000000000012753. Epub 2026 Apr 6. PMID 41940938
  • Tanikawa DYS, Figueroa AA. "Comparative Effectiveness of PLANA and Nasal Elevator in Presurgical Orthopedics: A 3D Anthropometric Study of Unilateral Cleft Lip.". Plast Reconstr Surg. 2026 May 20. doi: 10.1097/PRS.0000000000013220. Online ahead of print. PMID 42160712

Идентификаторы

NCT: NCT07687537 · IRB202600950

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗