Clinical trials: Preterm Infants, open to volunteers
Intraventricular Hemorrhage of Prematurity
Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a…
- Trial name
- ROPEDACEOIHIPI (NCT07157020)
- Testing
- ommaya capsule implantation technique
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Anemia
NeoSpHb Study: Can a Painless Device Detect Anaemia in Babies Without Blood Tests? A Study in the Neonatal Intensive Care Unit (NICU)
The goal of this study is to evaluate the diagnostic performance and feasibility of non-invasive spectrophotometric haemoglobin (SpHb) measurement for detecting anaemia in infants admitted to the Neonatal Intensive Care Unit…
- Trial name
- NeoSpHb (NCT07788703)
- Testing
- Spectrophotometry hemoglobin
- Where
- Malaysia
- Volunteers
- 30 people
- Sponsor
- University of Malaya
Bronchopulmonary Dysplasia (BPD)
Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity.
- Trial name
- ELVIRE (NCT07487259)
- Testing
- Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Infant, Premature
Automated Oxygen Control in Preterms on Non-invasive Ventilation
This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of…
- Conditions
- Infant, Premature, Airway Morbidity
- Trial name
- NCT07622563
- Testing
- Closed loop automated oxygen control
- Where
- United Kingdom
- Volunteers
- 76 people
- Sponsor
- King's College Hospital NHS Trust
Oral Feeding Outcomes, Neurodevelopment Outcome
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments.
- Trial name
- H-HOPE (NCT07372898)
- Testing
- H-HOPE
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Lymphedema, Premature Birth
Infant Massage for Lymphedema and Comfort in Preterm Newborns
This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care…
- Conditions
- Lymphedema, Premature Birth, Edema, Immobilization
- Trial name
- NCT07418814
- Testing
- Infant Massage Group
- Volunteers
- 40 people
- Sponsor
- Erzurum Technical University
Extremely Premature Infant
Vitamin A in Cord Blood and Preterm Outcomes
This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (<32 weeks' gestation) and to evaluate whether low cord blood vitamin A…
- Trial name
- NCT07296393
- Volunteers
- 155 people
- Sponsor
- The First Hospital of Jilin University
Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management.
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants, Intensive Care Units, Neonatal
- Trial name
- NCT06446453
- Testing
- Echography-guided Surfactant THERapy (ESTHER)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Connecticut Children's Medical Center
Premature Infant Disease, Apnea of Prematurity
Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital.
- Conditions
- Premature Infant Disease, Apnea of Prematurity, Development, Infant
- Trial name
- NCT06518603
- Testing
- Caffeine citrate 20mg/kg/day
- Where
- Zambia
- Volunteers
- 340 people
- Sponsor
- University of Alabama at Birmingham
5 Year Old Children Born Prematurely
Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.
- Trial name
- NCT07391527
- Testing
- Pediatric check-up
- Where
- 4 sites in Czechia
- Volunteers
- 210 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Intrauterine Growth Retardation (IUGR), Lung Function Tests
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound.
- Conditions
- Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant, Respiratory Monitoring
- Trial name
- ELFIGO (NCT06919757)
- Testing
- fetal ultrasound to assess lungs, heart and diaphragm
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs.
- Trial name
- FLOW-VENT (NCT07101419)
- Testing
- Long PRT, Short PRT
- Where
- 3 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Murdoch Childrens Research Institute
Preterm Newborns, Skin Integrity
Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous Monitoring
Neonates, especially when born prematurely, have an inherently fragile skin, due to the overall prematurity and to the immature composition of epidermidis and skin dermal structures.
- Trial name
- PRO-NEO-SKIN (NCT07753863)
- Testing
- Nellcor™ OxySoft™, MasimoRD SET NeoPt-500
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Paolo Manzoni Study Group
Growth Failure, Preterm Birth
Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation).
- Conditions
- Growth Failure, Preterm Birth, Microbiota
- Trial name
- IOCOIOPGIPI (NCT07082881)
- Testing
- Colostrum, Normal Saline
- Volunteers
- 220 people
- Sponsor
- Suqian First Hospital
Prematurity, Iron-deficiency
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency…
- Conditions
- Prematurity, Iron-deficiency, Iron Deficiency Anemia, Iron Malabsorption
- Trial name
- DIVI (NCT05340465)
- Testing
- Darbepoetin Alfa, Low Molecular Weight Iron Dextran, Ferumoxytol injection
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Washington
Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder
Home Play-based Intervention for Parents and Infants
The goal of this clinical trial is to learn whether a 12-week home-based intervention (Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)) helps support parenting and the development of…
- Conditions
- Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder, Premature Birth, Global Developmental Delay
- Trial name
- SPRINT (NCT07716072)
- Testing
- SPRINT Intervention, Waitlist Protocol
- Where
- Singapore
- Volunteers
- 120 people
- Sponsor
- Nanyang Technological University
Preterm Infant
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
- Trial name
- NCT06786039
- Testing
- Non-invasive NAVA
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Korea University Anam Hospital
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction
- Trial name
- NCT07088328
- Testing
- Pentoxifylline
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Bronchopulmonary Dysplasia (BPD)
Continued Pressure for Alveolar Protection (CPAP Trial)
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at…
- Trial name
- CPAP (NCT07417111)
- Testing
- CPAP, Nasal Cannula
- Where
- 15 sites in United States
- Volunteers
- 860 people
- Sponsor
- NICHD Neonatal Research Network