Clinical trials: Newborn Infant
Respiration; Insufficient or Poor, Newborn, Infant,Premature
Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment
The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age.
- Trial name
- ToNIL (NCT03586856)
- Testing
- Nasal mask interface, Nasal prongs interface
- Where
- 2 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Baldvin Jonsson
Lysosomal Acid Lipase Deficiency
An Expanded Access Protocol for Sebelipase Alfa for Patients With Lysosomal Acid Lipase Deficiency
This is an open-label, multicenter expanded access protocol to allow patients with a confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US), access to sebelipase alfa (recombinant lysosomal acid…
- Trial name
- NCT02376751
- Testing
- sebelipase alfa
- Sponsor
- Alexion Pharmaceuticals, Inc.
Echocardiography
Normal Reference Range for Neonatal Echocardiography
Echocardiography is the main method of bedside examination of neonatal cardiac morphology, which can timely diagnose congenital heart disease and quantitatively assess its severity, but the diagnosis and evaluation process…
- Trial name
- NORRNE (NCT05462301)
- Where
- China
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Chongqing Medical University
Epigenomics, Developmental Disability
Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities
Infants with developmental disabilities present a high risk of behavioral and socio-emotional problems. Their parents are themselves at risk of developing emotional and affective disorders which can impact the quality of the…
- Conditions
- Epigenomics, Developmental Disability, Early Intervention, Parent-Child Relations
- Trial name
- EPI-BOND (NCT03853564)
- Testing
- Video-Feedback Intervention, Phone-Call Intervention
- Where
- 3 sites in Italy
- Volunteers
- 45 people
- Sponsor
- IRCCS Eugenio Medea
Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants
- Conditions
- Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal
- Trial name
- RAMCAN (NCT03081611)
- Testing
- Ram cannula, Short nasal prongs
- Where
- Israel
- Volunteers
- 166 people
- Sponsor
- Rambam Health Care Campus
Healthy Volunteers
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors…
- Trial name
- NCT04286464
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Image Evaluation
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- Firefly (NCT02232009)
- Testing
- 3.0 T Neonatal MRI Scanner
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- GE Healthcare
TTN
The Effectiveness of Inhaled Salbutamol in the Management of Transient Tachypnea of the Newborn(TTN)
TTN is the most common respiratory disorder in the perinatal period, causing 40% of cases of respiratory distress after birth. Lung fluid absorption is initiated by beta-adrenergic agonists, such as endogenous steroids and…
- Trial name
- NCT07350421
- Testing
- Salbutamol (Albuterol), Normal Saline
- Where
- Syria
- Volunteers
- 1 people
- Sponsor
- Latakia University
Cystic Fibrosis
A Two-Part Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeat Doses of Inhaled ETD001 in People With Cystic Fibrosis
This study is the first to give ETD001 to people with CF. The study will be run in two parts. Part A will assess if ETD001 is safe to give to people with CF, and Part B will assess if ETD001 improves lung function.
- Trial name
- NCT06478706
- Testing
- ETD001
- Where
- 21 sites in France, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Enterprise Therapeutics Ltd
Jaundice, Neonatal
Research of Diagnostic Value for BMJ Infants
Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus.
- Trial name
- NCT04527536
- Testing
- Neonatal hyperbilirubinemia
- Volunteers
- 300 people
- Sponsor
- Shanghai First Maternity and Infant Hospital
Cerebral Palsy
Study of Parental Stress and Care Consumption Until 24 Months Corrected Age of Infants at a High Risk of Developmental Delay, After Discharge From Neonatal Intensive Care
Cerebral palsy (CP) is the leading cause of motor disability in children, affecting 125,000 people in France and with 1800 new cases per year.
- Trial name
- DeStreSs (NCT05233371)
- Testing
- Parenting Stress Index (PSI), Collection of health care consumption, Assessment of parent satisfaction
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Muscular Atrophy, Spinal
Newborn Screening for Spinal Muscular Atrophy
Spinal muscular atrophy (SMA) is a rare, treatable, genetic disease that typically occurs in infancy and early childhood. SMA progressively, and irreversibly, destroys motor neurons in the brainstem and spinal cord, which control…
- Trial name
- SMA-NBS (NCT05481164)
- Where
- 9 sites in United Kingdom
- Volunteers
- 33,568 people
- Sponsor
- University of Oxford
Neonatal Opioid Withdrawal Syndrome
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and…
- Trial name
- OBOE (NCT04149509)
- Where
- 6 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Cystic Fibrosis
Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis
The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem.
- Trial name
- NCT02048163
- Where
- United States
- Sponsor
- Dayton Children's Hospital
Cystic Fibrosis
Identification of Predictive Epigenetic Biomarkers of Lung Disease Severity in Cystic Fibrosis
The general aims of this project are (i) to identify predictive epigenetic biomarkers of lung disease severity in Cystic Fibrosis, (ii) to characterize a non-invasive cellular model, spontaneous sputum, for the analysis of these…
- Trial name
- MethylBiomark (NCT02976714)
- Testing
- spontaneous sputum
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Montpellier
Neonatal Encephalopathy, Epilepsy
Prevention of Epilepsy by Reducing Neonatal Encephalopathy
The aim of the study is to examine if a pragmatic, evidenced based and generalisable intrapartum care bundle involving birth companions and empowering mothers will reduce birth injury-related epilepsy at 18 months of age in…
- Conditions
- Neonatal Encephalopathy, Epilepsy, Newborn Morbidity
- Trial name
- PREVENT (NCT04054453)
- Testing
- Intra-partum care bundle invoking 4 elements
- Where
- 4 sites in India, United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Thayyil, Sudhin
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.
Pulmonary Hypertension of Newborn
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow.
- Trial name
- PaTTerN (NCT03132428)
- Testing
- INOmax
- Where
- 30 sites in United States
- Volunteers
- 140 people
- Sponsor
- Mallinckrodt
Cystic Fibrosis, Chronic Rhinosinusitis
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery.
- Trial name
- NCT00265434
- Testing
- Pulmozyme
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- University of Jena
Pregnancy
Effect During Pregnancy and Intrapartum Health
Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases…
- Trial name
- NCT03348332
- Testing
- Exercise pregnant women
- Where
- Spain
- Volunteers
- 530 people, healthy volunteers welcome
- Sponsor
- Technical University of Madrid
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