Treatment Trials

42 Clinical Trials for Various Conditions

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RECRUITING
A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children
Description

This study will test if giving parents access to their child's medical notes on a bedside tablet: * helps them get more involved in their care * helps identify safety concerns Parents of hospitalized children will be randomly assigned to either use the Bedside Notes tool or follow usual care. To see if this approach improves care and safety, researchers will measure: * note access * parent-reported safety concerns * overall experiences

ENROLLING_BY_INVITATION
Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation
Description

Children, ages 8 - 17, will be enrolled in a research study about the impact of aromatherapy on nausea in the pediatric rehabilitation unit.

Conditions
ACTIVE_NOT_RECRUITING
Addressing Unmet Social Needs Among Hospitalized Children
Description

The purpose of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol. The investigators will work with pediatric word healthcare team members to develop a social needs screening and intervention protocol. They will then compare preliminary health and social outcome measures between children hospitalized during the pre-intervention period (control group) vs. the post-intervention period (intervention group).

COMPLETED
Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children
Description

This is an experimental study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers (e.g., parents, guardians)

Conditions
COMPLETED
The Role of Therapy Dogs in Reducing Depression, Anxiety, and Loneliness Among Hospitalized Children
Description

The purpose of this research study is to test whether an animal-assisted intervention (AAI) is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services for children and adolescents.

ACTIVE_NOT_RECRUITING
Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
Description

This study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The hypothesis is that the multi-condition pathway intervention will be associated with significantly greater increases in clinicians' adoption of evidence-based practices compared to control. The study is a pragmatic, cluster-randomized trial in US community hospitals. The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.

COMPLETED
Discharge Medication Counseling in Hospitalized Children
Description

Our objective is to design and test the efficacy of a health-literacy-informed discharge medication counseling intervention in the inpatient setting to reduce medication dosing errors and improve adherence in hospitalized children discharged on a new liquid medication.

COMPLETED
Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
Description

Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic. Recent studies have demonstrated that a large majority of children with a penicillin allergy label do not have a true IgE-mediated allergy. Appropriately delabeling antibiotic allergies has been shown to improve patient care outcomes and lower health care costs. However, efforts to implement these assessments in practice are lacking, particularly in the hospital setting. Therefore, there is a need for hospital-based risk assessment and delabeling strategies for hospitalized children. The investigator's objective is to determine the feasibility of implementing a hospital-based approach to penicillin allergy risk stratification and evaluation of patients at low-risk for true allergy.

COMPLETED
Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial
Description

The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by comparing responses between TDV and non-TDV control groups.

COMPLETED
Sleep in Hospitalized Children at MSKCC
Description

The investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment.

COMPLETED
Anti-TNF Therapy for Refractory Colitis in Hospitalized Children
Description

This multicenter study is being conducted to determine whether infliximab exposure after an initial infusion is predictive of early clinical response in hospitalized pediatric patients with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish the infrastructure, demonstrate feasibility, and collect preliminary data to support the full study.

COMPLETED
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
Description

A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

COMPLETED
Evaluating a New Way to Prepare Parents of Hospitalized Children for Discharge and Management of Child at Home
Description

The purpose of this study is to pilot test the 'Family Self- Management Discharge Preparation Intervention \[FSM-DPI\]' that focuses on content and delivery methods to support an effective family transition to home self-management after a child's hospitalization.

COMPLETED
Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma
Description

The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma. Specific Aims and Objectives: 1. To determine the retention rate of parental knowledge about asthma; 2. To evaluate the clinical status, quality of life and healthcare costs of children with asthma following an educational intervention.

Conditions
TERMINATED
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
Description

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.

COMPLETED
Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children
Description

To assess whether a non-invasive cardiac output monitor can follow heart function in children during treatments in the hospital. To establish a normal reference for children who are well and awake.

COMPLETED
Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children
Description

The goal of this study is to demonstrate safety and efficacy of liquid risperidone in psychiatrically hospitalized children, ages 4-12, who would be put in seclusion or restraint, or given an intramuscular injection of diphenhydramine because of their out-of-control behavior if not medicated with risperidone. The first part of the study will: 1) develop appropriate oral doses of medication to reduce out of control or agitated behavior effectively with the fewest side effects, and 2) develop a rating system to measure the children's behavior i.e. level of improvement, sedation, and untoward effects.

Conditions
COMPLETED
Targeted Inpatient Navigation to Improve Care for Minority Children and Families
Description

The overall goal of this research is to evaluate a new program designed to address basic human needs, create a safe and supportive environment for families, and help families build skills and confidence for navigating the health care system. Specifically, we aim to pilot test the feasibility and acceptability of the Targeted Inpatient Navigation (TNav) program for families of low income, minority hospitalized children.

RECRUITING
Leveraging Electronic Health Record Tools to Improve the Evidence-Based Treatment of Children Hospitalized With Bronchiolitis
Description

The goal of this experimental study is to learn whether different types of best practice advisories (BPAs) that direct clinicians to reference clinical guidelines embedded in the electronic health record (EHR) increase the delivery of evidence-based care in children presenting to the hospital with bronchiolitis. The main questions it aims to answer are: * Do BPAs improve clinicians' delivery of guideline-concordant care in bronchiolitis? * Do interruptive BPAs improve guideline-concordant care of bronchiolitis more than non-interruptive BPAs? Researchers will compare the treatment and outcomes of patients whose clinicians did not receive a BPA, to those whose clinicians received a non-interruptive BPA, to those whose clinicians received an interruptive BPA. Patients will continue to receive standard hospital care for bronchiolitis. Clinicians will: * retain access to an EHR-embedded clinical guideline for bronchiolitis care * be exposed to either no BPA, a non-interruptive BPA, or an interruptive BPA promoting the EHR-embedded clinical guideline (randomized per patient encounter)

Conditions
RECRUITING
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Description

The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia. The main questions it aims to answer are: * Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children? * Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia? Participants will * be randomly assigned to either receive 5 total days or a total duration decided by the treating physician * receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.

TERMINATED
Steroids in Children Hospitalized With Asthma
Description

Asthma is the most common chronic disease of children. A short (3-5 day) course of a short-acting steroid such as Prednisone or Prednisolone has long been the standard of care for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the advantage of shorter course, more compliance, and more tolerable. This has led many emergency departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many inpatients have received a first dose of Dexamethasone prior to reaching the inpatient unit, leading to confusion about the best plan for these patients. Many hospitalist pediatricians continue to give a 5-day total course with Prednisone, but some patients have begun to receive a second dose of Dexamethasone 24 hours after the first dose. To our knowledge, no studies have been done to compare the efficacy of these two protocols in pediatric patients requiring hospitalization. The hypothesis is that a second dose of Dexamethasone is as effective as four additional days of Prednisone in hospitalized children with asthma exacerbation. This is an open label, randomized control study comparing these treatments in children age 2-18 hospitalized with asthma exacerbation who have received a first dose of Dexamethasone.

TERMINATED
Azithromycin for Children Hospitalized With Asthma
Description

Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Despite limited clinical evidence, some pediatricians use azithromycin in children hospitalized with asthma, citing either treatment of atypical pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.

Conditions
TERMINATED
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
Description

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.

TERMINATED
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
Description

The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.

COMPLETED
HFCWO in Hospitalized Asthmatic Children
Description

To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.

COMPLETED
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
Description

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.

COMPLETED
Oral Prednisolone Dosing in Children Hospitalized With Asthma
Description

This study hopes to determine the appropriate oral steroid dose for treating children hospitalized with asthma exacerbations. Practice guidelines from different countries recommend a wide range of doses, and the doses used in actual practice vary widely. There is no data on what is the most appropriate dose of prednisone (or equivalent) in this situation. We will be looking at the dose recommended by the National Asthma Education and Prevention Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as compared with a lower dose which is commonly used in practice. We hypothesize that the lower dose will be no worse than the higher dose as determined primarily by duration of hospitalization.

Conditions
COMPLETED
Family-Centered Rounds Checklist Implementation
Description

The goal of this study is to develop, implement, and evaluate the effectiveness of an intervention designed to facilitate family engagement during bedside rounds at a children's hospital. The intervention consists of a "checklist" of key behaviors associated with the delivery of quality family-centered rounds, as well as training in the use of the checklist tool. In a pre-post controlled design, two hospital services will be randomized to use the checklist while two others will be randomized to usual care. The intervention is expected to increase to the performance of key checklist behaviors, family engagement, and family perceptions of patient safety.

COMPLETED
The Impact of Starbright World on Children Being Treated at the NIH
Description

This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. Our outcome evaluation of SBW will include assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and willingness to return to the NIH for treatment of children who are being treated at NIH. They will be assessed while engaging in "normal" recreational activities (in one of two available playrooms) and while using Starbright World. In addition, we will conduct a process evaluation of the implementation of Starbright World.

WITHDRAWN
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19
Description

A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19