Clinical trials: Infant, Newborn, Disease
Cystic Fibrosis (CF), Cardiorespiratory Fitness
Assessment of Static and Dynamic Inspiratory Muscle Strength and Cardiorespiratory Fitness in Adults With Cystic Fibrosis
This study aims to examine and compare static and dynamic inspiratory muscle strength and cardiorespiratory fitness in adults with cystic fibrosis and their healthy peers.
- Conditions
- Cystic Fibrosis (CF), Cardiorespiratory Fitness, Inspiratory Muscle Strength
- Trial name
- NCT07895108
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Cystic Fibrosis, Dysbiosis
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the…
- Trial name
- NCT04118010
- Testing
- Vitamin D3, Inulin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Emory University
Cystic Fibrosis
Host and Bacterial Mechanisms During Cystic Fibrosis Pulmonary Exacerbations
Cystic fibrosis pulmonary exacerbations (CF PEx) vary greatly in their severity, their pathogens, and their treatment responses.
- Trial name
- NCT04354038
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- National Jewish Health
Prader-Willi Syndrome
PWS European Blood Bank for Infants and Controls From 0 to 48 Months
The present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS.
- Trial name
- NCT02529085
- Testing
- blood samples
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Infant, Extremely Premature, Acute Lung Injury
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo.
- Conditions
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity, Budesonide
- Trial name
- STOPCLD (NCT05364385)
- Testing
- Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Arizona
Preg Complications: Hemorrhagic, Infant, Premature, Diseases
Maternal & Infant Morbidity and Mortality
The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health.
- Conditions
- Preg Complications: Hemorrhagic, Infant, Premature, Diseases, Preg Complications: Hemorrhagic Intervillous of Placenta, Preg Complications: Bleeding From Female Genital Tract
- Trial name
- NCT06145568
- Testing
- Pregnant Women
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cerebral Hypoxia
Neonatal Brain Oxygenation Study
Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral…
- Trial name
- BOX (NCT04439968)
- Testing
- Clinical algorithm
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Ventilator-Induced Lung Injury, Respiratory Distress Syndrome
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator…
- Conditions
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Preterm Infant
- Trial name
- MIDAS (NCT03231735)
- Testing
- Mid frequency ventilation, Standard frequency ventilation
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
Cystic Fibrosis
PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis
Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to treatment of NTM disease has been identified as one of the…
- Trial name
- PATIENCE (NCT02419989)
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- National Jewish Health
Respiratory Distress Syndrome In Premature Infants, Bronchopulmonary Dysplasia
Seattle-PAP Bubble Nasal CPAP and Work of Breathing
The investigators propose to test the hypothesis that Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth weight (VLBW) infants more effectively than standard…
- Conditions
- Respiratory Distress Syndrome In Premature Infants, Bronchopulmonary Dysplasia, Newborn Primary Sleep Apnea
- Trial name
- Seattle-PAP (NCT02210026)
- Testing
- Seattle-PAP
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Seattle Children's Hospital
Preterm Birth, Premature Birth
Exposure to Plasticisers in the Neonatal Intensive Care Unit
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition.
- Conditions
- Preterm Birth, Premature Birth, Neurodevelopmental Disorders, Pulmonary Disease
- Trial name
- PLASTIC-NICU (NCT05404815)
- Where
- Belgium
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Preterm Birth, Prematurity
Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age
The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted…
- Conditions
- Preterm Birth, Prematurity, Infant,Premature, Infant Development
- Trial name
- NCT03357458
- Testing
- Family Integrated Care
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- University of Calgary
Immune System Diseases, Premature Infant Disease
Oral Colostrum and Its Effect on Immune System
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
- Conditions
- Immune System Diseases, Premature Infant Disease, Immunoglobulin Deficiency
- Trial name
- NCT03578341
- Testing
- Orally Colostrum
- Where
- 2 sites in Mexico
- Volunteers
- 96 people
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Hypoglycemia, Infant, Small for Gestational Age
Dextrose Gel Does Not Prevent Neonatal Hypoglycemia
This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.
- Conditions
- Hypoglycemia, Infant, Small for Gestational Age, Premature Birth of Newborn, Fetal Macrosomia
- Trial name
- NCT02523222
- Testing
- 40% Dextrose gel
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Baylor College of Medicine
Hirschsprung Disease
A Trial on Conservative Treatment for Infants' Hirschsprung Disease
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.
- Trial name
- NCT01985646
- Testing
- surgery treatment, anal dilation, colonic lavage
- Volunteers
- 48 people
- Sponsor
- Tongji Hospital
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)…
- Trial name
- ENVISION (NCT00909727)
- Testing
- Ivacaftor
- Where
- 29 sites in United States, Australia and 5 more
- Volunteers
- 52 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Graft Versus Host Disease, Hyperkalemia
Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair
Blood transfusions are required for patients undergoing a craniosynostosis repair due to the significant amount of blood loss. Irradiated or non-irradiated transfusions have many risks involved including elevated potassium levels…
- Conditions
- Graft Versus Host Disease, Hyperkalemia, Craniectomy, Synostectomy
- Trial name
- NCT02483702
- Testing
- Irradiated Blood Transfusions, Non-Irradiated Blood Transfusions
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Valley Anesthesiology Consultants
Rare Diseases
NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants
Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One group will receive cWGS and a clinical report approximately 15 days after blood samples are received, while the other group will continue…
- Trial name
- NICU-Seq (NCT03290469)
- Testing
- clinical whole genome sequencing (cWGS)
- Where
- 5 sites in United States
- Volunteers
- 355 people
- Sponsor
- Illumina, Inc.
Intrauterine Growth Restriction, Preterm Birth
Respiratory Morbidity of Late-Preterm Vs Intrauterine Growth Retarded Infants at School Age
Background: It is increasingly recognized that late preterm infants have increased respiratory morbidity in the neonatal period as well as decreased lung function in later life.
- Trial name
- NCT04849494
- Testing
- ATS-DLD-78-C and ISAAC questionnaires
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Marmara University