Clinical trials: Premature Neonates
Neonatal Respiratory Failure, Invasive Mechanical Ventilation
A Model for Predicting Extubation Success in Premature Babies
Invasive mechanical ventilation is a life-saving treatment in critically ill newborns with respiratory failure. However, continuing this treatment for a long time may have negative consequences, especially bronchopulmonary…
- Conditions
- Neonatal Respiratory Failure, Invasive Mechanical Ventilation, Extubation Failure
- Trial name
- NCT05081973
- Testing
- A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 114 people
- Sponsor
- Marmara University
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3
Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy
Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, <=27+6 weeks) and is associated with long-term neuro-disabilities.
- Conditions
- Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3, Intraventricular Haemorrhage Grade IV
- Trial name
- PIONIRS (NCT05708105)
- Testing
- Cerebral near-infrared spectroscopy, Functional echocardiography, Head Ultrasound
- Where
- 4 sites in Canada
- Volunteers
- 380 people
- Sponsor
- Mount Sinai Hospital, Canada
Hyponatremia, Premature
Early Sodium Intake in Preterm Newborns
Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome.
- Trial name
- NCT04035564
- Testing
- Sodium < 1mEq/kg/day, Sodium 5mEq/kg/day
- Where
- Mexico
- Volunteers
- 52 people
- Sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
Apnea, Bradycardia
Detection of Neonatal Bradycardia
Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment.
- Trial name
- INTEM (NCT00950287)
- Testing
- No intervention
- Where
- 3 sites in France
- Volunteers
- 54 people
- Sponsor
- Rennes University Hospital
Infant, Premature, Diseases, Birth, Preterm
The NEU - CAP Trial
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial.
- Conditions
- Infant, Premature, Diseases, Birth, Preterm, Respiratory Distress Neonatal
- Trial name
- NEU-CAP (NCT07754032)
- Testing
- Local standard care of monitoring non-invasive ventilation, CO₂-guided Non-Invasive Ventilation
- Volunteers
- 1,860 people
- Sponsor
- Leiden University Medical Center
Neonatal Skin Conditions
Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed.
- Trial name
- NCT06246864
- Testing
- Hydrocolloid dressing, Hypoallergenic Flexible
- Volunteers
- 60 people
- Sponsor
- Ondokuz Mayıs University
Retinopathy of Prematurity
Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids
The primary objectives of this study are to compare the serum and skin concentrations of beta-carotene, lutein, and lycopene in preterm infants fed preterm formulas with mixed carotenoids to serum concentrations in preterm…
- Trial name
- NCT00872664
- Testing
- carotenoids
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Utah
Premature Birth, Mothers of Newborn Infants
Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol
Mothers of premature newborns face special home care situations due to the conditions of their children after hospital discharge; This requires promoting the positive perception of maternal self-efficacy and thus achieving the…
- Trial name
- NCT06420635
- Testing
- Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children, Traditional kangaroo program
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Universidad de la Sabana
Respiratory Distress Syndrome, Newborn
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
- Trial name
- NINSAPP (NCT00751959)
- Testing
- Curosurf
- Where
- 13 sites in Germany
- Volunteers
- 213 people
- Sponsor
- University of Cologne
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
Intracranial Abscess
Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With IA
This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities.
- Trial name
- NCT07051382
- Testing
- Transcranial Sonographic Examination (Cranial Ultrasound)
- Where
- Pakistan
- Volunteers
- 122 people
- Sponsor
- Superior University
Neonatal Sepsis, Refractory Shock
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate
- Trial name
- NCT04110418
- Testing
- Methylene Blue
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Ain Shams University
Neonatal Infection
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable.
- Trial name
- EDELVAISS (NCT06656104)
- Testing
- Reference strategy, Experimental strategy
- Where
- 3 sites in France
- Volunteers
- 569 people
- Sponsor
- Hospices Civils de Lyon
Intraventricular Hemorrhage, Pulmonary Hemorrhage
Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation.
- Conditions
- Intraventricular Hemorrhage, Pulmonary Hemorrhage, Death, ELGAN (22-28SA)
- Trial name
- VEEP (NCT07273643)
- Testing
- Venous Cord blood sample, Arterial cord blood sample
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Retinopathy of Prematurity
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP.
- Trial name
- SPIPROP (NCT02344225)
- Testing
- Caffeine citrate, Ibuprofen, Ketorolac
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- State University of New York - Downstate Medical Center
Pain, Development
Trial of Repeated Analgesia With Kangaroo Care
Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a…
- Trial name
- TRAKC (NCT01561547)
- Testing
- Kangaroo Mother Care, Sucrose
- Where
- Canada
- Volunteers
- 242 people
- Sponsor
- IWK Health Centre
Respiratory Distress Syndrome, Infant, Premature
Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
In this mixed methods study, the investigators assessed feasibility of use of the PATH bCPAP kit on neonatal patients as well as the usability and acceptability of the device by healthcare workers.The study took place in a rural…
- Trial name
- NCT05462509
- Testing
- bCPAP with blenders
- Where
- Uganda
- Volunteers
- 14 people
- Sponsor
- PATH
Bronchopulmonary Dysplasia
Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia
This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature infants for moderate and severe Bronchopulmonary…
- Trial name
- NCT03558334
- Testing
- Transplantation of mesenchymal stem cell, No transplantation of mesenchymal stem cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Chongqing Medical University
Retinopathy of Prematurity, Pain
Acupuncture for Preterm Infants Requiring Eye-exam
The purpose is to investigate whether non-invasive acupuncture - NIA (i.e. acupuncture without needles) will help reduce pain for babies in the Neonatal Intensive Care Unit (NICU) during their routine weekly eye-exam for…
- Conditions
- Retinopathy of Prematurity, Pain, Acupuncture, Premature Infant
- Trial name
- MAGNIFIC-ROP (NCT03650621)
- Testing
- Magnetic acupuncture, stickers (magnets removed)
- Where
- 3 sites in Australia, Canada and 1 more
- Volunteers
- 100 people
- Sponsor
- University of Alberta
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