Clinical trials: Newborns
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
- Trial name
- NCT07897032
- Testing
- Levetiracetam, Therapeutic hypothermia (whole body cooling)
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Ventilator Pressure and Optimization of Compliance and Hemodynamics
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and…
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Extreme Prematurity, Ventilator Lung; Newborn
- Trial name
- VPOCH (NCT06512935)
- Testing
- Increase in the PEEP followed by decrease in the PEEP, Decrease in the PEEP followed by increase in the PEEP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Alabama at Birmingham
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the…
- Conditions
- Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion, Neonatal Brain Injury
- Trial name
- AMNIO-BRAIN (NCT07610642)
- Testing
- Intrauterine Pressure Catheter, Standard obstetric care at discretion of delivery provider
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medical College of Wisconsin
Apnea of Prematurity, Intermittent Hypoxemia
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
The goal of this clinical trial is to learn if a chin strap helps reduce low oxygen episodes in premature babies receiving CPAP or NIPPV (breathing support through the nose).
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bronchopulmonary Dysplasia of Newborn
- Trial name
- STRAP (NCT07895654)
- Testing
- Chinstrap
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Alpha 1 Antitrypsin Deficiency
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.
- Trial name
- RepAIR1 (NCT07431112)
- Testing
- AIR-001 SAD dose level 1, AIR-001 SAD dose level 2, AIR-001 SAD dose level 3
- Where
- 13 sites in Australia, Georgia and 7 more
- Volunteers
- 54 people
- Sponsor
- AIRNA Corporation
Neonatal Respiratory Distress Syndrome
Heated, Humidified High-flow Nasal (HHHFN) Cannula vs Nasal Continuous Positive Airway Pressure in Respiratory Distress in Premature Neonates
Newborn babies who have difficulty breathing may need breathing support to help them receive enough oxygen. Two commonly used methods are heated, humidified high-flow nasal cannula (HHFNC), which delivers warmed, moist air and…
- Trial name
- NCT07891494
- Testing
- Heated Humidified High-Flow Nasal Cannula therapy, nCPAP
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
Procedural Pain in Newborns
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
This study aims to evaluate the effect of a leg and foot massage program on pain in newborns receiving heel stick for monitoring serum bilirubin levels.
- Trial name
- NCT07893028
- Testing
- Leg and Foot Massage
- Where
- Thailand
- Volunteers
- 42 people
- Sponsor
- Chulalongkorn University
Post Partum Women, Newborn Health
Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the Auvergne Rhone-Alpes Region (AuRA)
Maternal mental health in the postpartum period is a major public health issue in France. The 2021 National Perinatal Survey highlights high prevalence rates of mental health disorders among mothers, with 27.6% experiencing…
- Trial name
- VISIMAT (NCT07653646)
- Testing
- psychological assessment
- Where
- 2 sites in France
- Volunteers
- 8,000 people
- Sponsor
- Centre Hospitalier Annecy Genevois
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
The aim of the study 1. To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates. 2.
- Conditions
- Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn, Congenital Diaphragmatic Hernia
- Trial name
- NCT07850934
- Testing
- Melatonin, nitric oxide generator
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- Ain Shams University
Fathers' Self-Efficacy and Ability in Newborn Care
Effectiveness of GEMPO E-Education on Fathers' Self-Efficacy and Ability in Newborn Care
This study aims to evaluate the effectiveness of GEMPO (Holding, Bathing, and Diaper Changing) e-education on fathers' self-efficacy and ability to care for newborns. The study will involve fathers of newborns aged 0-28 days.
- Trial name
- GEMPO (NCT07890077)
- Testing
- GEMPO Electronic Education
- Where
- Indonesia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Musnaini Musnaini
Hemolytic Disease of the Newborn, Fetal Anemia
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
The goal of this clinical trial is to learn if giving intravenous immunoglobulin directly to the fetus during intrauterine transfusion can improve newborn outcomes in pregnancies affected by rhesus isoimmunization.
- Conditions
- Hemolytic Disease of the Newborn, Fetal Anemia, Rhesus Isoimmunization, Erythroblastosis Fetalis Due to RH Antibodies
- Trial name
- NCT07885592
- Testing
- Intrauterine Transfusion, Intravenous immunoglobulin (IVIG)
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Neonatal Disease
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge.
- Trial name
- pNIRS (NCT05896306)
- Testing
- No intervention
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Graz
Procedural Pain, Heel Prick
ShotBlocker and Warm Gel Pack During Neonatal Heel Prick (HEAL)
This study evaluated the effects of ShotBlocker and a warm gel pack on pain, comfort, and physiological parameters during heel prick testing in healthy term newborns.
- Conditions
- Procedural Pain, Heel Prick, Newborn
- Trial name
- HEAL (NCT07686627)
- Testing
- ShotBlocker, Warm Gel Pack
- Where
- Turkey (Türkiye)
- Volunteers
- 139 people, healthy volunteers welcome
- Sponsor
- Marmara University
Sleep, Circadian Rhythm
HEARTBEAT SOUND FOR BREASTFEEDİNG DİFFİCULTİES: A RANDOMİZED CONTROLLED TRİAL
This randomized controlled trial aims to evaluate the effect of listening to a pre-recorded, standardized maternal heartbeat sound on perceived stress levels and breastfeeding self-efficacy in mothers experiencing early…
- Conditions
- Sleep, Circadian Rhythm, Pregnancy, Newborn
- Trial name
- NCT07881484
- Testing
- Standardized Maternal Heartbeat Sound Application
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hakan Avan
Postpartum Complication, Postpartum
Postpartum Care in the NICU Multi-Site Breastfeeding
Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the…
- Conditions
- Postpartum Complication, Postpartum, PTSD, PTSD (Childbirth-Related)
- Trial name
- PeliCaN (NCT07881731)
- Testing
- NICU-informed postpartum doula support
- Where
- 11 sites in United States
- Volunteers
- 640 people
- Sponsor
- Children's Hospital of Philadelphia
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
Neonatal Seizure, Neonatal Encephalopathy
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly…
- Conditions
- Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
- Trial name
- NEOLEV3 (NCT05610085)
- Testing
- Levetiracetam Injection, Phenobarbital Sodium Injection
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 133 people
- Sponsor
- University of California, San Diego
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
This cross-sectional study aims to evaluate the diagnostic accuracy of chest ultrasound in neonatal respiratory distress syndrome and to assess its potential prognostic value compared with chest X-ray.
- Trial name
- NCT07857304
- Volunteers
- 82 people
- Sponsor
- Assiut University
Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)
A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping
- Conditions
- Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy), Muscular Disorders, Atrophic, Muscular Disease
- Trial name
- SAFARI44 (NCT07587242)
- Testing
- AOC 1044
- Where
- 18 sites in Australia, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- Avidity Biosciences, Inc.
Healthy, Newborn Infant
Smart Sock Heart Rate Monitoring in Hospitalized Newborns
The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease.
- Trial name
- NCT07838402
- Where
- Finland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital