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Child, Only clinical trials

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NCT ID: NCT04941612 Recruiting - Child, Only Clinical Trials

Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures

Start date: May 25, 2021
Phase: N/A
Study type: Interventional

Background Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs. Methods The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up. Discussion This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.

NCT ID: NCT04826627 Recruiting - Child, Only Clinical Trials

Impact of Preoperative Fasting on Intraoperative Glycemic Homeostasis and Enhanced Recovery in Children

GLYNEMCaen
Start date: July 15, 2021
Phase:
Study type: Observational [Patient Registry]

In 2018, the main societies of anesthesia (European Society Anaesthesiology, European Society Pediatric Anesthesia, and Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française) changed the current recommendations for preoperative fasting time in children, reducing the time to last intake of clear liquids from two to one hour before anesthetic induction. Prolonged fasting may have a deleterious impact on blood glucose homeostasis. The consequences of intraoperative hypoglycemia in children can be serious in the short term, but also in the long term. The objective of multicenter prospective, observational cohort study is to investigate- in children younger than 24 months of age undergoing scheduled conventional inpatient surgery- a correlation between the duration of preoperative fasting, glycemic intraoperative homeostasis and the criteria of enhanced recovery after surgery, which are the hospital length of stay (main outcome), postoperative pain and postoperative nausea-vomiting (secondary outcomes). By identifying non-adherence to fasting rules as one of the causes of prolonged hospitalization, this study will highlight the need to develop effective strategies to promote adherence to fasting rules in pediatric surgery and minimize the potential deleterious impact on intraoperative glycemic control.

NCT ID: NCT04743024 Recruiting - Clinical trials for Alcohol Use Disorder

TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda

TREAT C-AUD
Start date: December 27, 2020
Phase:
Study type: Observational

The investigators will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. The investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. The project is approaching the research topic using quantitative and qualitative methods. The TREAT C-AUD research project will therefore document to which degree alcohol drinking is a problem among children in Mbale, Eastern Uganda.

NCT ID: NCT04709432 Recruiting - Child, Only Clinical Trials

ECMO Treatment of Children in China in the Past 10 Years

Start date: January 11, 2021
Phase:
Study type: Observational

It is a cross-sectional study to summarize the extracorporeal membrane oxygenation (ECMO)treatment in children in China.

NCT ID: NCT04691349 Recruiting - Child, Only Clinical Trials

CAR-T for r/r Malignant Tumors in Children

Start date: September 27, 2020
Phase: Early Phase 1
Study type: Interventional

This study is a clinical study of CAR-T treatment of patients with relapsed/refractory malignant tumors in children. The purpose is to evaluate the safety and effectiveness of chimeric antigen receptor T cells in the treatment of relapsed/refractory malignant tumors in children.

NCT ID: NCT04579198 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Using mHealth to Improve Emotional Recovery After Pediatric Injury

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

Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.

NCT ID: NCT04435470 Recruiting - Critical Illness Clinical Trials

Epidemiological Study of the Microbiota in Critically Ill Children

BIOUCIP
Start date: June 1, 2020
Phase:
Study type: Observational

Objectives: To study the composition of the microbiota in critically ill children, and to know the relationship of its microbiota with clinical complications and inflammation biomarkers. Design: Multicenter observational and prospective study including 100 critically ill children admitted in three pediatric intensive care units with a prediction of more than 5 days of stay and 50 healthy children. Clinical parameters and rectal, fecal, blood and respiratory samples will be collected at admission and at pediatric intensive care units discharge. The microbiota and inflammation biomarkers and metabolomic will be analyzed. Analysis of results: Description an evolution of the microbiota throughout the time, intestinal and respiratory, and the influence of clinical and therapeutic factors will be analyzed. The composition of microbiota will be compared with a cohort of healthy children and between the different types of pediatric intensive care units. The correlation of the microbiota with the markers of inflammation, metabolomics and the development of infectious complications and multiorgan failure will be analyzed.

NCT ID: NCT04406818 Recruiting - Sickle Cell Disease Clinical Trials

Metabolic and Hemodynamic Reserve in Pediatric SCA

Start date: June 30, 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life. SCA participants and healthy controls are age and sex-matched for comparison. Within the SCA cohort, children with infarcts may have thinner cortices than those without, reflecting a greater loss. The investigators will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels may vary by age. The brain's blood flow changes in small ways during everyday activities, such exercise, deep concentration, or normal brain growth. Significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." In less extreme circumstances, not having a full oxygen supply may cause the brain to grow and develop more slowly than when it has a full supply. One way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism. During this study participants may be asked to undergo a blood draw, MRI, cognitive assessments, and brief questionnaires. The study team will use a special mask to control the amount of carbon dioxide the participants breathe in.

NCT ID: NCT04224987 Recruiting - Mortality Clinical Trials

Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

AVENIR
Start date: November 24, 2020
Phase: Phase 4
Study type: Interventional

The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested. The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on antimicrobial resistance.