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Pediatrics clinical trials

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NCT ID: NCT06201130 Recruiting - Clinical trials for Microbial Colonization

Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.

Start date: December 20, 2023
Phase:
Study type: Observational

Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. These devices are not without a risk of infection - ventilator-associated infections (VAIs), namely ventilator associated pneumonia (VAP) and ventilator-associated tracheitis (VAT), are common. Treatment of suspected VAI accounts for nearly half of all Pediatric Intensive Care Unit (PICU) antibiotic use. VAI can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. Colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. Tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. When patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. There however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. This research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. This study will involve the prospective collection of tracheal aspirates from patients with artificial airways. We will screen and enroll all patients admitted to a the NICU or PICU at Cohen Children's Medical Center (CCMC) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. Tracheal aspirates are routinely obtained in the NICU and PICU from suctioning of an artificial airway and is a minimal risk activity. These samples will be brought to the Feinstein Institutes for Medical Research for 16 s ribosomal DNA (16srDNA) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. Tracheal aspirate sets will be analyzed against each other. Additionally, clinical and epidemiological data from the electronic medical record will be obtained. Antibiotic exposure will be accounted for via previously published means.

NCT ID: NCT06163183 Completed - Pediatrics Clinical Trials

Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

Start date: August 1, 2014
Phase:
Study type: Observational

This study aimed to record diaphragm electrical activity (Edi) during the preextubation (weaning) and postextubation periods and to analyze whether Edi monitoring could predict extubation success.

NCT ID: NCT06146465 Recruiting - Pediatrics Clinical Trials

Mobile Health Applications in Pediatric Patient Management: Clinicians' Perceptions, Expectations and Experiences

Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to to determine the perceptions, expectations and experiences of physicians involved in pediatric patient management about mHealth applications. The main questions it aims to answer are: - Is the use of mHealth applications in pediatric patient management different between pediatricians and other specialties? - What are the most commonly used mHealth applications in pediatric patient management? Participants will fill out an online survey form.

NCT ID: NCT06098105 Completed - Ultrasound Clinical Trials

Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics

Start date: October 24, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.

NCT ID: NCT06064045 Active, not recruiting - Pediatrics Clinical Trials

Using Simulation to Support Staff and Improve Quality of Treatment: An Intervention Project Within Pediatrics

PAEDSIM
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Background: Effective teamwork and quality care are crucial for patient safety overall. Simulation-based team training offers a valuable approach to improving communication, coordination, and decision-making among healthcare professionals, leading to better outcomes and a safer healthcare environment. By evaluating the effectiveness of this training method, the project aims to contribute to the continuous improvement of healthcare delivery. Hypothesis: Implementation of simulation-based team training in pediatric departments will lead to improved teamwork, communication, and coordination among healthcare professionals, resulting in enhanced patient outcomes and a safer healthcare environment. Setup: From April 2023 to April 2024 a simulation-based training program will be implemented. The intervention group consists of healthcare professionals working as physicians or nurses in four pediatric departments. The intervention entails increasing the quantity of simulation-based team training within the intervention group. Additionally, measures to enhance and support simulation will be introduced within the intervention group. Concurrently, another four pediatric departments will serve as a control group, in which no intervention will be implemented. Both groups consist of approximately 600 healthcare professionals, contributing to a total of 1,200 participants included in this project. Data collection: Registration of simulation: The simulation facilitator responsible for each session completes a brief web-based questionnaire made readily accessible from all platforms by QR-code. Data includes Regional ID (unique personal identifier), gender, age, profession, simulation duration, and content, as well as learning goals. Outcome measures include 1) patient safety culture, 2) rate of sick leave among healthcare professionals, 3) Apgar score, and 4) an intervention cost-benefit analysis.

NCT ID: NCT06039150 Enrolling by invitation - Post Operative Pain Clinical Trials

Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies

M-TAPA
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are: - Is M-TAPA block more effective in reducing pain? - How M-TAPA block affects the use of rescue analgesics in the postoperative period? Participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. Participants in the M-TAPA group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.

NCT ID: NCT06034392 Enrolling by invitation - Pediatrics Clinical Trials

CHAMP App Cardiac Study and Repository

CHAMP
Start date: August 25, 2023
Phase:
Study type: Observational [Patient Registry]

This is a multi-site research study with an optional research repository that will consist of clinically derived data and photographic or video images of patients in the home setting with complex health conditions to evaluate the safety and efficacy of the CHAMP® software platform, with data and photographic or video images input and/or uploaded by the parent or other legally authorized representative (LAR) of patients with complex congenital heart disease as a target population.

NCT ID: NCT05975658 Enrolling by invitation - Pediatrics Clinical Trials

WIReD: Wireless Interstage Remote Device Study

WIReD
Start date: September 30, 2023
Phase:
Study type: Observational

A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).

NCT ID: NCT05922605 Recruiting - Pediatrics Clinical Trials

Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

Start date: June 20, 2023
Phase: Phase 4
Study type: Interventional

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious. Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

NCT ID: NCT05837000 Recruiting - Dexmedetomidine Clinical Trials

Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair

Start date: May 15, 2023
Phase: Phase 4
Study type: Interventional

Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.