Clinical trials: Term Infant, open to volunteers
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction
Infants With Severe Acute Respiratory Distress Syndrome: The Prone Trial
The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome.
- Conditions
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction, Infant
- Trial name
- NCT05002478
- Testing
- Prone positioning
- Where
- Austria
- Volunteers
- 14 people
- Sponsor
- Medical University of Vienna
Preterm Infants, Term Infants
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal…
- Conditions
- Preterm Infants, Term Infants, Necrotising Enterocolitis, Atresia; Bowel
- Trial name
- INTINE (NCT06092463)
- Where
- 2 sites in Denmark
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Respiratory Distress Syndrome (Neonatal), Surfactant
Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth.
- Trial name
- SPLASH (NCT07176117)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA), Continuous Positive Airway Pressure (CPAP)
- Where
- 3 sites in United States
- Volunteers
- 422 people
- Sponsor
- Sharp HealthCare
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Term Infant, Late Preterm Infant
Brain Uptrain to Improve Learning and Development
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age.
- Trial name
- BUILD (NCT06638801)
- Testing
- Coach-led caregiver-implemented early literacy and developmental programming, Reach Out and Read Training
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- University of Alabama at Birmingham
Premature Baby, Pulmonary Hypertension of Newborn
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
This study aims to improve how neonatologists check the heart function of newborn babies, especially those who are sick. While standard heart ultrasound scans are useful, a more advanced and sensitive technique called 2D speckle…
- Conditions
- Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia
- Trial name
- NCT07364682
- Where
- United Kingdom
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's NHS Foundation Trust
Adenosine Deaminase Deficiency, Severe Combined Immunodeficiency (SCID)
An Observational LTFU Study for Patients Previously Treated With Autologous ex Vivo Gene Therapy for ADA-SCID
This observational long-term follow-up study is designed to collect safety and efficacy data from ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA LV encoding for human…
- Trial name
- NCT04049084
- Testing
- autologous ex vivo gene therapy products based on the EFS LV encoding for the human adenosine deaminase (ADA) gene (EFS-ADA LV)
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 70 people
- Sponsor
- University of California, Los Angeles
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
Lung Function, BPD - Bronchopulmonary Dysplasia
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood.
- Trial name
- EMBLEM (NCT06065215)
- Testing
- Magnetic Resonance Imaging (MRI), Echocardiogram, Lung ultrasound
- Where
- 4 sites in Canada
- Volunteers
- 319 people
- Sponsor
- Children's Hospital of Eastern Ontario
Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of…
- Trial name
- NCT04218318
- Testing
- phototherapy
- Where
- Saudi Arabia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity
Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus…
- Trial name
- TREOCAPA-LT (NCT06064825)
- Testing
- 2 year follow-up of neurodevelopment using a parental questionnaire
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Cow Milk Protein Allergy
Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
- Trial name
- NCT07711938
- Testing
- New generation eHF, Commercial eHF
- Volunteers
- 410 people
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Failure
Low and High Flow Suctioning in Intubated Infants
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW).
- Trial name
- NCT06443970
- Testing
- Exsalta Suction Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Columbia University
Bronchiolitis, Clinical Phenotype
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis is a common viral infection of the small airways that affects infants, particularly during respiratory syncytial virus epidemics.
- Conditions
- Bronchiolitis, Clinical Phenotype, Nutritionnal Impairment, Short-Term Enteral Nutrition
- Trial name
- STENP-PER (NCT07901400)
- Testing
- Usual inpatient bronchiolitis care, STENP-PER care pathway
- Where
- 8 sites in France
- Volunteers
- 448 people
- Sponsor
- Hospices Civils de Lyon
Neurodevelopmental Disorders, Motor Skills Disorders
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
This study examines how early motor behavior in infants relates to their later psychomotor development. Researchers will observe both preterm and full-term infants during the first months of life, using video-based assessments to…
- Conditions
- Neurodevelopmental Disorders, Motor Skills Disorders, Infant, Premature Development, Infant, Term Development
- Trial name
- NCT07296003
- Testing
- Vojta method
- Where
- 3 sites in Czechia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Masaryk University
Necrotizing Enterocolitis, Intestinal Perforation
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall.
- Conditions
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- Trial name
- NOR-NEC (NCT06757582)
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- University Hospital of North Norway
Bronchopulmonary Dysplasia
Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly.
- Trial name
- NCT06270199
- Testing
- Control, Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions, Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
- Where
- 7 sites in Spain
- Volunteers
- 75 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Feeding Delays, Neonates and Term Infants
BabySTrong II taVNS Feeding Trial
The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the…
- Trial name
- BabySTrong II (NCT07049952)
- Testing
- taVNS, NAC and taVNS, inactive taVNS
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Medical University of South Carolina
Bronchopulmonary Dysplasia
Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below.
- Trial name
- NCT07561125
- Testing
- intravenous immunoglobulin
- Where
- China
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- International Peace Maternity and Child Health Hospital
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products