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Pediatric clinical trials

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NCT ID: NCT04953169 Recruiting - Critical Illness Clinical Trials

Examining Health Literacy in Biorepository Consents

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

Previous research has shown that most parents would allow their child's leftover blood to be included in a de-identified biorepository using opt-out consent in an outpatient setting. In a pilot study to evaluate Pediatric Intensive Care Unit (PICU) parents' preferences and comprehension of a written opt-in consent to include their child's sample in a biorepository, the investigators showed 19% of parents did not agree to participate in the Biobank, more than the 8.7% reported in other settings. Parent comprehension varied. and the investigators also noted differential enrollment by sociodemographic factors. Critically ill children and their parents are vulnerable; seeking consent for non-therapeutic research in critical care requires special consideration. Therefore, the goal of this study is to evaluate whether the addition of a stakeholder influenced (parent, clinical research professionals) video aided consent will improve comprehension and rates of enrollment across diverse groups in this high intensity setting.

NCT ID: NCT04679792 Recruiting - Pediatric Clinical Trials

Postual Control in Pediatric Chiari I Malformation

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

BACKGROUND: Chiari I malformation is a rare disease characterized by cerebellar amygdalae descent under the level of the foramen magnum. It causes troubles in cerebrospinal fluid circulation and direct compression on brainstem, producing characteristic headaches, neurological impairment and syringomyelia. Surgery is the only treatment, indicated when symptomatology exists. However, sometimes patients complaint about atypical symptoms that are difficult to interpret. We would like to study one of these atypical symptoms, gait imbalance, in a pediatric population thanks to a computerized dynamic posturography (Equitest®). METHOD: infants from 6 to 18 years of age presenting a radiologically confirmed Chiari I malformation will be included in the study. We will compare posturographic results of patients which will be operated on with the results of the patients which will not; furthermore, we will compare preoperative and postoperative results in operated patients. RESULTS: 19 patients have been enrolled in the study, and data have been collected for 12 of them. Seven patients belong to operated population. CONCLUSIONS: even if enrolment of the patients is satisfactory, disposable data are not enough to perform statistical analysis and to put forward any conclusion.

NCT ID: NCT04266132 Recruiting - Inguinal Hernia Clinical Trials

Ultrasound Guided Retrolaminar Block for Pediatric Inguinal Hernia

Start date: May 17, 2020
Phase: N/A
Study type: Interventional

Regional analgesia for inguinal hernia repair in children has attracted increasing interest and different techniques like Caudal block, lumbar epidural block, wound infiltration, Ilio-inguinal nerve block and paravertebral block have been used with varying success. Ilio-inguinal nerve blockade has been widely used in this context but the duration of the block is also limited to the early postoperative period. Paravertebral blockade has been shown to produce long lasting postoperative analgesia when used in combination with general anaesthesia in paediatric herniorrhaphy . Ultrasound-guided retrolaminar block is one of the newer and technically simpler alternatives to the traditional PV block . The aim of this study is to test the efficacy and safety of ultrasound guided retrolaminar block(RLB) as an analgesic technique in surgery of pediatric inguinal hernia in comparison with with ilioinguinal nerve block(INB). It is hypothesized that RLB block will provide longer duration of postoperative analgesia than INB with few side effects.

NCT ID: NCT04206683 Recruiting - Pediatric Clinical Trials

Cerebral Oxygenation and Burst Suppression

Start date: January 20, 2020
Phase:
Study type: Observational

investigators want to observe a group of pediatric patients who are going to undergo open thoracic surgery at Queen Silvia's child and youth hospital, Sahlgrenska University Hospital. Population that has been selected is between 6-36 months due to the fact that the physiological development does not differ significantly with respect to drug response and circulation. During general anesthesia and surgery, investigators will use an NIRS). A sensor is placed frontally on the head. This comparative study will study the relationship between regional oxygenation frontal and 2/4-channel EEG. An EEG sensor with adhesive will also be attached to the frontal on patient's forehead next to tendons from NIRS. Participants will be consulted consecutively at the thoracic surgeon who will undergo open thoracic surgery with the support of the hair removal machine and who have the intended age for the study at Queen Silvia's Children's and Youth Hospital, Salhgrenska University Hospital. Peroperatively, data collection will occur in 5-minute intervals for frontal and occipital measurements. The measurements are started before the patient is anesthetized and terminated when the patient is awakened. Usual monitoring parameters under general anesthesia will be collected and documented, see protocol.

NCT ID: NCT03721783 Recruiting - Pediatric Clinical Trials

Infant and Child European Cryoablation Project ICECaP

Start date: June 24, 2021
Phase:
Study type: Observational [Patient Registry]

A registry to audit the current range of applications, technical success rate, safety profile, complication rate and efficacy of cryoablation procedures being performed in children.

NCT ID: NCT03571542 Recruiting - Clinical trials for Kidney Transplantation

Evaluation of the Respiratory Function in Renal Transplanted Children

SPIROKID
Start date: July 16, 2018
Phase: N/A
Study type: Interventional

Objectives: While a respiratory abnormality was found in 50% of pediatric renal transplant recipients in a study conducted in Belgium and the Netherlands in 2008, the respiratory status of transplanted children in France remains unknown. The primary objective of this study is to assess the prevalence of respiratory impairment and its characteristics in children with renal transplant. The secondary objective is to study its association with some potential risk factors such as immunosuppressive therapy or humoral immunodeficiency. Methodology: This interventional study aims to recruit the 385 children currently being followed by 5 French pediatric renal transplant centers between June 2018 and November 2019. A clinical and functional respiratory assessment will be carried out during the routine annual follow-up of the transplant recipient. Children with clinical signs of concern or abnormal spirometry will be referred to a respiratory specialist. Pharmacokinetic assays of immunosuppressant therapy and the exploration of humoral function will also be performed. The prevalence and type of respiratory abnormalities will be described. Logistic regression will be used to explore the association between potential risk factors and impaired respiratory function. Expected results: This study will be the first to evaluate the respiratory status of children with renal transplants in France. The prospective, multi- centered nature of the study, in addition to the large cohort size (which represents two thirds of children with renal transplants in France) will guarantee current, reliable, and representative data for the target population. We will provide new knowledge by precisely characterizing the type of lung injury and looking for potential risk factors. If our study confirms the high prevalence of pulmonary impairment in children with renal transplants, systematic monitoring of respiratory function may be recommended to enable early diagnosis and management. The expected individual and public health benefits would be significant by limiting the appearance of long-term, irreversible sequelae (such as non-cystic-fibrosis bronchiectasis) and improving the quality of life of these patients.

NCT ID: NCT03243019 Recruiting - Pediatric Clinical Trials

Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations

RAPAMALYMPH
Start date: June 25, 2018
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period. The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.

NCT ID: NCT02286297 Recruiting - Pediatric Clinical Trials

Pediatric Endotracheal Intubation During Resuscitation

PETI
Start date: November 2014
Phase: N/A
Study type: Interventional

Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of different available video laryngoscopes and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.

NCT ID: NCT01046448 Recruiting - Clinical trials for Cardiovascular Disease

The Cardiovascular Comorbidity in Children With Chronic Kidney Disease Study

4C
Start date: July 2009
Phase: N/A
Study type: Observational

Children and adolescents with chronic kidney disease (CKD) are at high risk for cardiovascular (CV) morbidity and mortality. Recent studies suggest that pediatric patients with even moderately impaired kidney function may be afflicted with significant early cardiac and vascular abnormalities. The pathogenesis and the natural course of CV comorbidity in pediatric CKD patients is still elusive. In this multicenter, prospective, observational study the prevalence, degree and progression of CV comorbidity in children will be characterized and related to CKD progression. The morphology and function of the heart and vessels will be monitored by sensitive, non-invasive methods and will be compared with aged matched healthy controls. Multiple potential clinical, anthropometric, biochemical, and pharmacological risk factors will be monitored prospectively and will be related to CV status. Genotyping might identify predisposing genetic factors for progression of CV comorbidity and underlying nephropathies.

NCT ID: NCT00265772 Recruiting - Crohn's Disease Clinical Trials

Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis

Start date: November 2005
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to compare the efficacy of enteral nutrition compared to steroids in inducing remission of active pediatric Crohn’s disease. The main hypothesis of this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do not. This effect may be related to a change of the commensal flora during enteral nutrition.