Clinical trials: Very Preterm Birth, active
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Neonatal Respiratory Distress Syndrome, PreTerm Neonate
MINImising Total Radiation EXposure in Preterm Infants
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive.
- Trial name
- MINI T-Rex (NCT06975189)
- Testing
- Lung ultrasound group, Standard Care
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Western Health, Australia
Preterm
Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial
The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk.
- Trial name
- NCT07702318
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Rush University Medical Center
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens
Very Preterm Birth
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's…
- Trial name
- CALIN (NCT04380051)
- Testing
- sensory-tonic stimulation, skin-to-skin contact
- Where
- France
- Volunteers
- 120 people
- Sponsor
- CHU de Reims
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Cerebral Palsy, Prematurity
Best Practices Fo Early Diagnosis of Cerebral Palsy
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e.
- Trial name
- CP (NCT06537622)
- Testing
- Implementation group, Standard of care
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Prematurity
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age.
- Trial name
- SPIN-NA (NCT07169110)
- Testing
- SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
- Where
- France
- Volunteers
- 35 people
- Sponsor
- University Hospital, Toulouse
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
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
Very Premature Baby
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
The growth and organization of the cerebral cortex is ensured by the oligodendrocyte-rich subplate, whose proper development depends on both subcortical structures and sensory experiences.
- Trial name
- PIVOT (NCT07903766)
- Testing
- Multisensory intervention program, Standard care
- Volunteers
- 144 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Preterm Birth, Premature Lungs
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to…
- Conditions
- Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT06295484
- Testing
- Alternating traditional CPAP, NIPPV, and high CPAP
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Very Preterm and Extremely Preterm Birth
Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very…
- Trial name
- SAFE (NCT07562997)
- Testing
- Urine sodium testing, Serum sodium testing, Milk fortification
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Premature Infant, Respiratory Distress Syndrome in Premature Infant
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before…
- Conditions
- Premature Infant, Respiratory Distress Syndrome in Premature Infant, Neurodevelopmental Outcome
- Trial name
- HiLo (NCT03825835)
- Testing
- 30% oxygen group, 60% oxygen group
- Where
- 14 sites in Canada, Ireland
- Volunteers
- 1,203 people
- Sponsor
- University of Alberta
PreTerm Neonate, Sedation for Invasive Mechanical Ventilation
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency.
- Conditions
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- Trial name
- DEXPRE (NCT06878703)
- Testing
- Midazolam, Dexmedetomidine
- Where
- France
- Volunteers
- 380 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Prematurity
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27…
- Trial name
- MAGIC (NCT06420531)
- Testing
- Human milk
- Where
- 4 sites in United States
- Volunteers
- 486 people
- Sponsor
- University of Alabama at Birmingham
Respiratory Distress Syndrome in Premature Infant
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better.
- Trial name
- NEOSURF (NCT07098910)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA), Intubation - Surfactant administration - Extubation (INSURE)
- Where
- Vietnam
- Volunteers
- 440 people
- Sponsor
- Karolinska Institutet
Premature Infant
Calmer Brains in Very Preterm Infants
Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development.
- Trial name
- NCT07262385
- Testing
- Calmer
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children