Clinical trials: High-risk Infants
Respiratory Distress Syndrome
High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)
Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks gestation; surfactant and mechanical ventilation have been the standard treatment.
- Trial name
- NCT01496508
- Testing
- mechanical ventilation (SLE 5000, Servo-i-Maquet)
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Zhengzhou Children's Hospital, China
Infant, Cerebral Palsy
Early Support and Physiotherapy for Children and Their Motor Skills
The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool.
- Conditions
- Infant, Cerebral Palsy, Neonatal
- Trial name
- App-eMot-Quali (NCT04523441)
- Testing
- Focus group, Semi-directive interview
- Where
- France
- Volunteers
- 37 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Neonatal Abstinence Syndrome
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
- Trial name
- NCT04419857
- Testing
- High-calorie formula
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Yale University
Bronchiolitis
Treatment of Pediatric Bronchiolitis
Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants that affects the bronchioles of babies under 24 months of age.
- Trial name
- NCT03835936
- Testing
- High frequency compression of the chest wall group, Manual maneuvers physiotherapy group
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Guadarrama Hospital
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Breast Cancer
Women At Risk: The High Risk Breast Cancer Program
The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry.
- Trial name
- WAR (NCT01034891)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- New York Presbyterian Hospital
Neonatal Abstinence Syndrome
RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes…
- Trial name
- NCT02178189
- Testing
- High Calorie Infant formula, Standard Calorie Infant Formula
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- University of Pittsburgh
Early Intervention
Effectiveness of Telerehabilitation in High Risk of Infants
While the mortality rate in preterm births has decreased thanks to recent developments in the field of medicine, disability risk factors increase for premature babies.
- Trial name
- NCT05333224
- Testing
- Telerehabilitation, Home-based
- Where
- Turkey (Türkiye)
- Volunteers
- 26 people
- Sponsor
- Saglik Bilimleri Universitesi
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Cystic Fibrosis
Comparison of Airway Clearance Efficacy of Two High Frequency Chest Wall Oscillation (HFCWO) Devices in Cystic Fibrosis
Patients with cystic fibrosis (CF) must perform daily bronchial drainage therapy (BD) to keep their airways clear of secretions.
- Trial name
- NCT00308958
- Testing
- High frequency chest wall oscillator
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Minnesota
Rapid Sequence Induction (RSI), Preoxygenation
High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children
Airway management is crucial part of the anaesthesia. There is always a considerable risk of complications or even failure during the anaesthesia induction and airway management.
- Trial name
- PRSIHFO (NCT05846919)
- Testing
- face-mask preoxygenation, HFNOC preoxygenation, HFNOC + face-mask preoxygenation
- Where
- Czechia
- Volunteers
- 4 people
- Sponsor
- Brno University Hospital
Infant,Premature, Bronchopulmonary Dysplasia
L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW < 1500 g).
- Conditions
- Infant,Premature, Bronchopulmonary Dysplasia, Pulmonary Hypertension
- Trial name
- NCT03542812
- Testing
- L-Citrulline
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Utah
Chronic Liver Disease, Thyroid Disease
The Development of Quantitative Ultrasound Imaging Software Platform
The goal of this observational study is to compare the image differences between conventional ultrasound and artificial intelligence-based ultrasound software in conscious adults.
- Conditions
- Chronic Liver Disease, Thyroid Disease, Benign Breast Disease, Malignant Breast Neoplasm
- Trial name
- NCT05836246
- Where
- South Korea
- Volunteers
- 196 people
- Sponsor
- Seoul National University Bundang Hospital
Lingual Frenum, High Power Laser
Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin lingual frenulum that can restrict the movements of the tongue and has been identified as one of the factors that can negatively interfere…
- Conditions
- Lingual Frenum, High Power Laser, Breast Feeding
- Trial name
- NCT04487418
- Testing
- Electro cautery surgery, High power diode laser surgery
- Volunteers
- 56 people
- Sponsor
- University of Nove de Julho
Respiratory Distress Syndrome, Preterm Infant
Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome
In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key…
- Trial name
- NHFOV (NCT03140891)
- Testing
- NHFOV, NCPAP
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Bronchiolitis
High Flow Nasal Cannula Use in Infants With Bronchiolitis
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been…
- Trial name
- NCT02737280
- Testing
- Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy, MedKit Finland - Usual oxygen therapy
- Where
- 4 sites in Finland
- Volunteers
- 18 people
- Sponsor
- University of Oulu
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.
Cystic Fibrosis
HFN Versus NIV in Cystic Fibrosis. The HIFEN Study
Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit (ICU) admission because of acute exacerbation of chronic respiratory failure or for any acute deterioration of clinical status.
- Trial name
- NCT02262871
- Testing
- High flow nasal oxygen cannula, Noninvasive ventilation
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Unity Health Toronto
Gestational Diabetes, Obesity
Healthy Diet for Healthy Moms and Babies
The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the…
- Conditions
- Gestational Diabetes, Obesity, Pregnancy, High Risk
- Trial name
- NCT03467503
- Testing
- Blueberry + soluble fiber
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Nevada, Las Vegas