Warsawa, Poland
Product Surveillance Registry
Phase
N/ASpan
1466 weeksSponsor
MedtronicNew Hyde Park, New York
Recruiting
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
This intervention development study will enroll three to four consecutive cohorts to receive Starting Early to Prevent Obesity Using Telehealth (StEP OUT), an online, group-based nutrition education and parenting support program beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy. It is tailored to Hispanic/Latinx families. StEP OUT will be delivered by a registered dietician/certified lactation counselor in coordination with the Long Island Jewish Medical Center Special Supplemental Nutrition Program for Women, Infants, and Children (LIJ WIC). The StEP OUT curriculum is based on the Starting Early Program (StEP), which uses didactic instruction, reflective discussion, interactive demonstrations, and hands-on practicing of skills to support prenatal nutrition and healthy early infant feeding practices. The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and our Community Advisory Board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. Each session will conclude with a structured feedback discussion designed to elicit targets and strategies for further program adaptation. We will collect feasibility and acceptability data after each session and at the end of the five-session program for each cohort. The iterative intervention adaptation process will be complete once all participants rate the intervention as "acceptable" or higher and fidelity is 90% or higher. We anticipate meeting this benchmark after 3 cohorts but may need to recruit an additional cohort to test subsequent adaptations, if necessary.
Phase
N/ASpan
134 weeksSponsor
Northwell HealthNew Hyde Park, New York
Recruiting
IPV and Lung Compliance in Invasively Ventilated Children
Phase
N/ASpan
103 weeksSponsor
Northwell HealthNew Hyde Park, New York
Recruiting
Pediatric Down Syndrome Post-Approval Study
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow sixty (60) adolescents (13 - 18), with Down Syndrome and severe sleep apnea for 5-years after undergoing implant of the Inspire Upper Airway Stimulation (UAS) system. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatrics Down Syndrome population. Prior to implant subjects will be required to meet eligibility criteria that is based on an in-lab PSG, surgical consultation and drug induced sleep endoscopy, as well as other assessments. Subjects will also complete quality of life questionnaires. During the 5-year follow-up period, data will be collected at the time of implant, and at multiple follow-up visits through five years post-implant. At each of these visits, safety information (adverse events), sleep data, therapy usage, and quality of life will be collected. A total of sixty (60) subjects with even distribution across the age range will be implanted at a minimum of five (5) clinical centers in the US. Subjects will conclude their participation in the study at the end of their 5 year follow-up visit.
Phase
N/ASpan
278 weeksSponsor
Inspire Medical Systems, Inc.Queens, New York
Recruiting
Comparing the Effectiveness of Matched Related Donor Hematopoietic Stem Cell Transplantation to Disease Modifying Therapy in Pediatric Patients With Sickle Cell Disease
The WeDecide study is a large observational study comparing the long-term effects of two treatment options for pediatric patients with sickle cell disease (SCD): matched related donor hematopoietic stem cell transplantation (MRD HCT) and non-transplant disease-modifying therapies (NT-DMT). The main goal is to understand how these treatments affect health-related quality of life (HRQoL) and cognitive function, using standard tools to measure both physical and mental health. The study also looks at risks and benefits of MRD HCT, such as the potential for chronic complications, improved survival, and prevention of organ damage. The study includes two groups: 160 children receiving MRD HCT and 320 children receiving NT-DMT. Participants, aged 3-20.9 years, are being followed for three years. The MRD HCT group will be assessed before the transplant and then at several points post-transplant. The NT-DMT group will be assessed at the start of the study and then annually for three years. The research also considers factors like disease severity, treatment history, and social determinants of health (such as family finances and caregiver health literacy) to better understand how these elements might influence treatment outcomes. The study tracks the use of disease-modifying therapies, as well as hospital visits and other care events, throughout the three years. It will also monitor survival rates and other important health outcomes. This study is significant because it is the first large-scale research comparing these two treatment options for SCD in children. The results will provide essential insights into how these treatments impact long-term health and help guide clinical decisions and treatment recommendations. The goal is to help families and healthcare providers make informed decisions about the best treatment options for SCD. The study uses advanced methods to ensure fair comparisons between the two groups by accounting for differences in their characteristics. It will also adjust for any factors that could influence the results, helping to identify meaningful differences in health outcomes between the two treatments. Ultimately, the WeDecide study aims to improve our understanding of sickle cell disease treatment and provide a foundation for future research into new therapies.
Phase
N/ASpan
340 weeksSponsor
University of RochesterQueens, New York
Recruiting
Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
Pediatric participants will be enrolled as follows: - Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to < 40 kg - Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
Phase
2Span
61 weeksSponsor
Gilead SciencesPhoenix, Arizona
Recruiting
Interventional Study Exploring the Occurrence of Surgical Site Infections.
Phase
N/ASpan
39 weeksSponsor
Molnlycke Health Care ABGarden City, New York
Recruiting
EXpanding Prenatal Cell Free DNA Screening Across MoNogenic Disorders (EXPAND)
Natera sgNIPT is intended for use in pregnant people whose fetus/ fetuses are identified as at increased risk for a single gene disorder, such as one of the disorders below, when there is no reproductive partner (paternal) screening available or when there is positive reproductive partner screening, but prenatal diagnostic testing is not an option or when there is concern for a single-gene disorder in the fetus/ fetuses irrespective of carrier status (e.g., based on fetal ultrasound findings). Disorders include: CF (CFTR) SMA (SMN1) Alpha-thalassemia (HBA1/HBA2) Beta-hemoglobinopathies including sickle cell disease (HBB)
Phase
N/ASpan
110 weeksSponsor
Natera, Inc.New Hyde Park, New York
Recruiting
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
PRIMARY OBJECTIVES: I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device. II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples. SECONDARY OBJECTIVES: I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study. ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
Phase
N/ASpan
137 weeksSponsor
Mayo ClinicNew Hyde Park, New York
Recruiting
Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.
Phase
N/ASpan
80 weeksSponsor
Northwell HealthQueens, New York
Recruiting