Clinical trials: Preterm Infant, active
Very Preterm Birth
High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth
This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach…
- Trial name
- NCT06909929
- Testing
- Lipid IV 2 g, lipid IV 1 gram
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Respiratory Distress Syndrome, Newborn, Infant, Premature
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist…
- Trial name
- NCT05427929
- Testing
- NVR 4mm Edi catheter
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Mount Sinai Hospital, Canada
Extreme Prematurity (gestational Age Below 29 Weeks)
Oral Feeding Skills of Very Premature Infants
Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term…
- Trial name
- NUTRIO (NCT06657729)
- Testing
- Succiometry
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Bronchopulmonary Dysplasia (BPD), Premature Births
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Trial name
- PRISM (NCT07101640)
- Testing
- montelukast 4 mg granule
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Premature Birth, Psychological Stress
Parental Stress and Attachment in Preterm Infants
Introduction: Advances in neonatology mean a significant reduction in mortality in premature infants as well as an increase in the risk of morbidity in the medium, short and long term.
- Conditions
- Premature Birth, Psychological Stress, Physiological Stress
- Trial name
- NCT06813560
- Testing
- hair cortisol, salivary cortisol, salivary Oxytocin
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cardenal Herrera University
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Retinopathy of Prematurity, Preterm Infants
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected…
- Trial name
- NCT06315556
- Testing
- Aflibercept (Eylea)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
Language Delay, Language Development
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings…
- Conditions
- Language Delay, Language Development, Feeding; Difficult, Newborn, Mother-Infant Interaction
- Trial name
- NCT05861531
- Testing
- Oromotor stimulation, Reading curriculum, LENA recording
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
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
Infant, Premature, Diseases, Birth, Preterm
The NEU-STIM Trial
The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth.
- Trial name
- NEU-STIM (NCT05942924)
- Testing
- Repeated tactile stimulation, Selective tactile stimulation
- Where
- 43 sites in Austria, Belgium and 17 more
- Volunteers
- 3,280 people
- Sponsor
- Leiden University Medical Center
Bronchopulmonary Dysplasia
Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia (BPD), or chronic lung disease of prematurity, is the most consequential complication of preterm birth and is strong predictor of childhood pulmonary and neurodevelopmental disability, particularly in…
- Trial name
- NCT06475976
- Testing
- Chest computed tomography (CT) with angiography, Bronchoscopy with bronchoalveolar lavage, Echocardiography
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Children's Hospital of Philadelphia
Premature Infant, Risk Factors
Perinatal Risk Factors in Motor Development
The aim of this study is to analyze the effect of preterm gestational age, birth weight and perinatal risks factors on gross motor development of preterm infants.
- Conditions
- Premature Infant, Risk Factors, Motor Development of Premature Infants
- Trial name
- NCT07310459
- Where
- Spain
- Volunteers
- 160 people
- Sponsor
- Universidad de Murcia
Osteopathy, PreTerm Neonate
The Effect of Cranial Osteopathy Intervention in Preterm Babies
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated.
- Conditions
- Osteopathy, PreTerm Neonate, Sensory Profiles, Colic
- Trial name
- NCT06967870
- Testing
- Osteopathic intervention, Home based exercise education
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Preterm Birth, Premature Birth
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.
- Conditions
- Preterm Birth, Premature Birth, Complication of Prematurity, Obstetric Labor, Premature
- Trial name
- SNACS (NCT05114096)
- Testing
- Celestone + Celestone
- Where
- 25 sites in Canada
- Volunteers
- 3,254 people
- Sponsor
- McMaster University
Necrotizing Enterocolitis, Microbial Substitution
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term…
- Trial name
- NCT05272579
- Testing
- Fecal Filtrate Transfer
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Cerebral Palsy Infantile, Pre-Term
Motor-voice Assessment in Infants (MAMI)
The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants..
- Conditions
- Cerebral Palsy Infantile, Pre-Term, Motor Delay, Neurodevelopmental Disorders
- Trial name
- MAMI (NCT06807203)
- Testing
- Behavioral observation
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Ohio State University
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
Lung Injury, Preterm Birth
Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating.
- Trial name
- POLAR (NCT04372953)
- Testing
- Positive End-Expiratory Pressure (PEEP)
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 906 people
- Sponsor
- Murdoch Childrens Research Institute
Bronchopulmonary Dysplasia
Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.
- Trial name
- NCT06579157
- Testing
- Pressure-Sensing Mattresses
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Fu Jen Catholic University
Neonatal Respiratory Distress Syndrome
To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation
A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of <32 weeks were enrolled.
- Trial name
- NCT07235345
- Testing
- According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xu Falin