Clinical trials: Preterm
Premature Birth of Newborn, Critically Ill
The Use of Methadone in Newborn Infants
This proposed investigation will test the following hypotheses: 1) Enzymatic activity of CYP2B6 characterized by the formation clearance of methadone to EDDP (CLf,EDDP), is directly related to both gestational and postnatal age…
- Trial name
- Methadone (NCT01327079)
- Testing
- Methadone
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- John van den Anker
Pre-Term
MusicHyperBrain Study With Preterm Infants and Their Parents
Inter-personal brain coupling between preterm infants, their parents and a musician during Creative Music Therapy using functional near-infrared imaging (fNIRI) hyperscanning and systemic physiology measurements
- Trial name
- NCT05383586
- Testing
- Creative Music Therapy
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Neonatal Prematurity, Patent Ductus Arteriosus in Preterm Infants
Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
- Conditions
- Neonatal Prematurity, Patent Ductus Arteriosus in Preterm Infants, Prostaglandins
- Trial name
- NCT07338370
- Testing
- Ibuprofen (Brufen®)
- Where
- Egypt
- Volunteers
- 34 people
- Sponsor
- Ain Shams University
Premature Birth, Extreme Prematurity
The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants
To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6…
- Conditions
- Premature Birth, Extreme Prematurity, Preterm Intraventricular Hemorrhage, Hypoxia-Ischemia, Cerebral
- Trial name
- NCT05490173
- Testing
- Exosomes derived from mesenchymal stromal cells (MSCs)
- Where
- Russia
- Volunteers
- 10 people
- Sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Parenting, Preterm Infants
Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates
In a hospital environment, initial parenting of a family with a preterm neonate will be very different than expected. This unusual and stressful situation may determine the self-confidence perceived by mothers and fathers in…
- Conditions
- Parenting, Preterm Infants, Training Support
- Trial name
- CAP-PREM (NCT02803866)
- Testing
- Training program CAP-PREM
- Where
- Spain
- Volunteers
- 16 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
Intraventricular Hemorrhage
Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants
The most frequent complications in premature infants are neurological complications: intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe intraventricular hemorrhages remains stable.
- Trial name
- HEMO PREMA (NCT02400853)
- Testing
- Standard cranial echography, Cord blood analysis
- Where
- France
- Volunteers
- 175 people
- Sponsor
- University Hospital, Rouen
Preterm Birth, Complication of Prematurity
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants.
- Conditions
- Preterm Birth, Complication of Prematurity, Obstetric Labor, Premature, Obstetric Labor Complications
- Trial name
- SNACS Pilot (NCT04494529)
- Testing
- 24 mg betamethasone
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- McMaster University
Maternal Infection During Pregnancy (Diagnosis), Neonatal Infection
Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis
The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with…
- Trial name
- NCT02985086
- Testing
- Cefoxitin, oxytocin/misoprostol
- Where
- 2 sites in Portugal
- Volunteers
- 568 people, healthy volunteers welcome
- Sponsor
- Hospital de Santa Maria, Portugal
Preterm Membrane Rupture, Neonatal Sepsis
Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes
There is no consensus around the world on the treatment of preterm rupture of membranes, which is one of the important causes of early neonatal sepsis and one of the common causes of prematurity.
- Trial name
- NCT04528251
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Preterm Birth, Neurodevelopmental Disorders
Swaddling to Improve Neurodevelopment for Preterm Babies
The investigators will test a new medical grade swaddling system for optimal and more appropriate positioning for preterm infants. This is a trial focused on sleep state, state regulation and long-term neurodevelopment.
- Trial name
- NCT04715451
- Testing
- Novel Swaddle
- Sponsor
- Johns Hopkins University
Hypovitaminosis D
Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants
Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of vitamin D deficiency in early preterm infants is unknown.
- Trial name
- NCT01793402
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Pregnancy, Pregnancy Complications
AI-POCUS for Maternal and Neonatal Health in Ethiopia
Maternal and neonatal health remains one of the most pressing global health challenges, particularly in low- and middle-income countries (LMICs).
- Conditions
- Pregnancy, Pregnancy Complications, Preterm Birth, Fetal Growth Restriction
- Trial name
- AIM-ETH (NCT07171086)
- Testing
- AI-POCUS (BabyChecker, Delft Imaging), AI-POCUS (Edan, China)
- Where
- Ethiopia
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Tsinghua University
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
Necrotising Enterocolitis
Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%.
- Trial name
- NCT03188380
- Testing
- Plain abdominal radiography, Abdominal ultrasound
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Premature
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother.
- Trial name
- DHARMA (NCT01062373)
- Testing
- Supplementation of lactating mothers who has delivered prematurely with DHA
- Where
- France
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Neonatal Respiratory Distress Syndrome
Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
Respiratory distress is one of the first hospital grounds during the neonatal period. The clinical presentation and severity vary by gestational age and cause.
- Trial name
- DROPE (NCT02824497)
- Testing
- No intervention. It's a description study
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Behavior, Nesting, Behavior, Child
Hammock Position and Nesting in the Neonatal Intensive Care Unit
This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies.
- Trial name
- NCT06209060
- Testing
- Hammock Position, Nesting
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Maltepe University
Respiratory Distress Syndrome, Newborn, Respiratory Failure
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and…
- Trial name
- NCT01941524
- Testing
- Poractant alfa instillation, Beractant instillation
- Where
- Poland
- Volunteers
- 22 people
- Sponsor
- Poznan University of Medical Sciences
Premature Lungs, Respiratory Distress Syndrome
Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants
This study is being conducted to determine whether prophylactic administration of surfactant by the Less Invasive Surfactant Administration (LISA) method reduces the need for mechanical ventilation in the first 72 hours of life…
- Conditions
- Premature Lungs, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
- Trial name
- CaLI (NCT04209946)
- Testing
- Less Invasive Surfactant Administration LISA, Continuous Positive Airway Pressure CPAP
- Where
- 3 sites in United States
- Volunteers
- 180 people
- Sponsor
- Sharp HealthCare
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