Clinical trials: NEWBORN
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
Infant, Premature, Diseases, Premature Birth of Newborn
Elevated Midline Positioning During Diaper Change in Preterm Infants
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants.
- Conditions
- Infant, Premature, Diseases, Premature Birth of Newborn, Pain
- Trial name
- NCT07865897
- Testing
- 30-Degree Elevated Midline Positioning, Standard Lateral Position Diaper Change
- Volunteers
- 80 people
- Sponsor
- Akdeniz University
Cesarean Delivery Affecting Newborn, Acidosis
Ephedrine Versus Norepinephrine and Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia
This study compares ephedrine and norepinephrine for the treatment of low blood pressure (hypotension) that may occur during cesarean delivery under spinal anesthesia.
- Conditions
- Cesarean Delivery Affecting Newborn, Acidosis, Maternal Hypotension, Spinal Aneshtesia
- Trial name
- NEO-FET (NCT06921473)
- Testing
- Norepinephrine, Ephedrine
- Where
- Turkey (Türkiye)
- Volunteers
- 155 people
- Sponsor
- mehmet özkılıç
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
The HIEnome Study: Genome Sequencing for Perinatal HIE
Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE)
- Trial name
- NCT06762795
- Testing
- Genome sequencing
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor College of Medicine
Hypothermia, Immature Newborn
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO…
- Trial name
- NCT01604317
- Testing
- Resuscitation-torso plastic bag, Resuscitation-partial-head plastic bag
- Where
- Zambia
- Volunteers
- 182 people
- Sponsor
- University of Alabama at Birmingham
Mild Hypoxic Ischemic Encephalopathy of Newborn
Cool Prime Comparative Effectiveness Study for Mild HIE
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family.
- Trial name
- COOLPRIME (NCT04621279)
- Testing
- Normothermia, Whole body therapeutic hypothermia
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- University of Texas Southwestern Medical Center
Hemolytic Disease of the Fetus and Newborn
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby…
- Trial name
- AZALEA (NCT05912517)
- Testing
- Nipocalimab
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Hemolytic Disease of the Fetus and Newborn
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk…
- Trial name
- GERANIUM (NCT07194070)
- Testing
- Standard of Care
- Where
- 15 sites in United States, Australia and 6 more
- Volunteers
- 175 people
- Sponsor
- Janssen Research & Development, LLC
Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
Title : A multicenter clinical trial of the portable nitric oxide generation and delivery system (INOwill N200) for the treatment of neonatal hypoxic respiratory failure complicated by pulmonary hypertension Investigational…
- Trial name
- iNOwill Neonat (NCT07837921)
- Testing
- Nitric Oxide Generator and Delivery System
- Volunteers
- 50 people
- Sponsor
- Novlead Inc.
Respiratory Distress Syndrome (RDS), Newborn
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support.
- Conditions
- Respiratory Distress Syndrome (RDS), Newborn, Premature Birth
- Trial name
- NOV-RDS (NCT07837141)
- Testing
- Noninvasive High Frequency Oscillatory Ventilation, Nasal Intermittent Mandatory Ventilation
- Where
- Pakistan
- Volunteers
- 158 people
- Sponsor
- Aga Khan University
Newborn Jaundice
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia
- Trial name
- NCT05282394
- Testing
- Abdominal massage, Reading
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Down Syndrome, Obstructive Sleep Apnea of Newborn
Early Detection and Treatment of Obstructive Sleep Apnoea in Infants With Down Syndrome
Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with…
- Trial name
- RESPIRE21 (NCT03210675)
- Testing
- Polysomnography (PSG)
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Institut Jerome Lejeune
Premature Newborns, Cranial Asymmetry
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time…
- Trial name
- plagiocephaly (NCT07758426)
- Testing
- Tummy Time Protocol
- Where
- Brazil
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
Retinopathy of Prematurity (ROP)
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- (BabySTEPS3) (NCT07738874)
- Testing
- Ultra-widefield Optical Coherence Tomography (UWF-OCT), Wide-field ophthalmic imaging system
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Duke University
Newborn Complication, Catheter Complications
Intravenous Neonatal Central Access Safety Trial
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU).
- Trial name
- INCAS (NCT05537389)
- Testing
- In-line filter
- Where
- Italy
- Volunteers
- 768 people
- Sponsor
- University of Turin, Italy
Congenital Heart Disease, Fetal Heart Disorder
Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on…
- Conditions
- Congenital Heart Disease, Fetal Heart Disorder, Neonatal Disease, Fetal Disease
- Trial name
- NCT07820163
- Volunteers
- 115 people
- Sponsor
- Assiut University
Hypertension, Pulmonary, Infant, Newborn, Diseases
Predictors of Outcomes in Pulmonary Hypertension of the Newborn
This prospective cohort study aims to identify the clinical, laboratory, and echocardiographic predictors of outcomes among neonates diagnosed with persistent pulmonary hypertension of the newborn at Assiut University Children…
- Trial name
- NCT07822750
- Volunteers
- 60 people
- Sponsor
- Assiut University