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Craniosynostoses clinical trials

View clinical trials related to Craniosynostoses.

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NCT ID: NCT06425172 Not yet recruiting - Plagiocephaly Clinical Trials

Monitoring System for Cranial Orthoses

Start date: June 1, 2024
Phase:
Study type: Observational

This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).

NCT ID: NCT06366178 Not yet recruiting - Craniosynostoses Clinical Trials

EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses

EPBONF
Start date: December 1, 2024
Phase: N/A
Study type: Interventional

Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed. The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter. There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment. A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology. The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF.

NCT ID: NCT06294626 Completed - Developmental Delay Clinical Trials

Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly

Start date: January 1, 2019
Phase:
Study type: Observational

It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases. 21 infants diagnosed with scaphocephaly aged 2-17 months were included. - Is there any delay in the neuromotor development of scaphocephaly cases? - If delay is observed, in which area is it most common? Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants.

NCT ID: NCT06263075 Recruiting - Hemorrhage Clinical Trials

Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)

CRASY-PRAM
Start date: December 13, 2023
Phase:
Study type: Observational

Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated. Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses. This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.

NCT ID: NCT06069479 Recruiting - Metopic Synostosis Clinical Trials

Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs

Treat Trigono
Start date: September 1, 2022
Phase:
Study type: Observational

RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically. OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs.

NCT ID: NCT05917678 Recruiting - Torticollis Clinical Trials

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Start date: May 23, 2023
Phase: N/A
Study type: Interventional

This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.

NCT ID: NCT05911139 Enrolling by invitation - Anesthesia Clinical Trials

Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy

TAnBrainDam
Start date: October 1, 2022
Phase:
Study type: Observational [Patient Registry]

The issue of anesthetics neurotoxicity is one of the most discussed topics in pediatric anesthesiology, thus it opens the question of the safety of commonly used anesthetics in the pediatric patient. Preclinical studies have shown that anesthetics can have a toxic effect on the maturing brain of pups and cause cognitive impairment. In human medicine, the influence of anesthetics is studied by monitoring the psychomotor development of children who have undergone surgery under general anesthesia. Some work deals with laboratory evidence of brain damage due to general anesthesia, but none of the work deals with the observation of markers of brain damage in infants. The aim of this work is to examine the dynamics of changes in the concentrations of selected markers of brain damage in craniosynostosis operations under general anesthesia in infants in order to optimize perioperative management and the correct timing of surgery.

NCT ID: NCT05511168 Not yet recruiting - Craniosynostoses Clinical Trials

Craniosynostosis :Surgical Treatment Modalities and Outcome

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Aim of study: 1. To evaluate outcome of cases( cosmoses and cognition) after Craniosynostosis surgery 2. - To ascertain intra- and postoperative complications

NCT ID: NCT05154175 Completed - Clinical trials for Plagiocephaly, Nonsynostotic

Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both

Start date: November 15, 2021
Phase:
Study type: Observational

The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. This research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.

NCT ID: NCT04827524 Completed - Craniosynostoses Clinical Trials

Investigation of Anthropometric Properties of Babies With Craniosynostosis

Start date: October 1, 2020
Phase:
Study type: Observational

Craniosynostosis is a malformation affecting the head and face, in which one or more sutures in the skull are fused prematurely. Premature union of one or more sutures causes changes in the shape of the skull base and dome, resulting in asymmetrical or restricted head and facial enlargement. It has been reported that in craniosynostosis, the bone enlargement is perpendicular to the fused sutures with the counterbalancing expansion. Craniosynostosis usually involves the union of a single cranial suture, but in some cases it has been observed that it may involve more than one suture in the baby's skull. An asymmetrical appearance is observed on the faces of babies, especially an unusual appearance in the form of eyes and skulls. It may present with neurological defects such as hydrocephalus, mental retardation, vision and hearing loss, as well as cosmetic deformities in the skull and facial bones. The general prevalence of craniosynostosis is around 1/2500 births. Generally, in single suture synostoses, there is no clear neurological finding except deformity. In multisuture synostoses there are a wide spectrum of findings such as increased intracranial pressure, hydrocephalus, syringomyelia, Chiari malformation, venous anomalies, ophthalmologic problems, growth retardation and epilepsy. Early diagnosis and treatment provides enough room for the baby's brain to grow and develop. It is thought that by measuring the anthropometric properties of these babies, the course of their development will be examined.