Clinical trials: Preterm Neonates, active
Premature, Feeding Disorders
Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates
This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.
- Conditions
- Premature, Feeding Disorders, Lactase Deficiency, Congenital
- Trial name
- NCT07088302
- Testing
- lactase administration
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Alexandria University
NEC, Necrotizing Enterocolitis
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs…
- Conditions
- NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development
- Trial name
- NiiCE (NCT06681129)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
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
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
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
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
Moral Distress
The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
Due to highly specialized medical care neonatal care providers are faced with numerous responsibilities which makes neonatal care a particularly challenging and stressful work environment.
- Trial name
- MoD (NCT06836323)
- Where
- Switzerland
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Preterm Birth Complication, Neonatal Morbidity and Mortality
Delayed Versus Immediate Cord Clamping in Preterm Birth
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping
- Trial name
- PREM-CORD (NCT07699666)
- Testing
- Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping
- Where
- Tunisia
- Volunteers
- 200 people
- Sponsor
- Faculty of Medicine of Tunis
Preterm Premature Rupture of Membranes (PPROM)
TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden
The goal of this clinical trial is to learn whether tailoring antibiotic and steroid treatment based on a lab result (interleukin-6, or IL-6) from amniotic fluid can help safely prolong pregnancy in people with preterm premature…
- Trial name
- TAILORED-PROM (NCT07107477)
- Testing
- Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes, Antenatal steroids administration, Neuroprotection
- Where
- 3 sites in Czechia
- Volunteers
- 138 people
- Sponsor
- The Central and Eastern European Gynecologic Oncology Group
Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication
Parent Perceptions of OptiPAP Junior
To evaluate how different forms of respiratory support affect parent interaction, how parents feel about different methods of support, and how their child's current respiratory support level is perceived in the setting of…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication, Pulmonary, CPAP
- Trial name
- NCT07837700
- Testing
- Nasal CPAP interface: OptiPAP Junior, Nasal CPAP interface: FlexiTrunk
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Sharp HealthCare
Preeclampsia, Preterm Birth
Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
The Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative…
- Conditions
- Preeclampsia, Preterm Birth, Pregnancy Complications, Fetal Anomalies
- Trial name
- NCT02744365
- Testing
- Observational
- Where
- Canada
- Volunteers
- 7,845 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Preterm Infant, Body Temperature
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment.
- Trial name
- ThermoKPreterm (NCT03919188)
- Testing
- air temperature control (ATC), skin servocontrol (SSC)
- Where
- France
- Volunteers
- 164 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens