Clinical trials: Infant, Newborn
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 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
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
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
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
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
Newborn Respiratory Distress, Preterm Infant
Short Term Effects of Synchronized vs. Non-synchronized NIPPV in Preterm Infants.
Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns…
- Trial name
- SyncNIV (NCT03289936)
- Testing
- NIPPV, SNIPPV
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Turin, Italy
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Many babies born very preterm (<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Trial name
- PrePAP (NCT07251790)
- Testing
- Pre-extubation continuous positive airway pressure
- Where
- 3 sites in Australia
- Volunteers
- 134 people
- Sponsor
- Murdoch Childrens Research Institute
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal)
Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS).
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Respiratory Distress Syndrome of Newborn
- Trial name
- NCT07550218
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and…
- Trial name
- NCT07442669
- Testing
- Lung ultrasound
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hackensack Meridian Health
Single-ventricle, Infant Conditions
PK/PD of Digoxin in Infants With SVHD
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in…
- Conditions
- Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases
- Trial name
- Digoxin R01 (NCT06613477)
- Testing
- PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Duke University
Nutrition Disorders, Gastrointestinal Disease
Review of Infant Oral Feeding and Skills
This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral…
- Conditions
- Nutrition Disorders, Gastrointestinal Disease, Deglutition Disorder, Feeding Difficulties
- Trial name
- RIOS (NCT06736743)
- Testing
- SMART Tool for Feeding Skill Assessment
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Wake Forest University Health Sciences
Infant, Newborn, Diseases, Bowel Sounds
Detection of Infant GastrointEstinal Activity Using Sound Technology
This pilot study aims to evaluate the feasibility and safety of continuous bowel sound monitoring in healthy term newborn infants using a novel wireless acoustic monitoring system.
- Conditions
- Infant, Newborn, Diseases, Bowel Sounds, Physiologic Monitoring, Wearable Sensors
- Trial name
- DIGEST (NCT07743216)
- Volunteers
- 10 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Premature Birth of Newborn, Retinopathy of Prematurity (ROP)
A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.
- Conditions
- Premature Birth of Newborn, Retinopathy of Prematurity (ROP), Low Birthweight Infant
- Trial name
- SChiROP (NCT06729333)
- Where
- China
- Volunteers
- 4,841 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
HIV, HIV Infections
Evaluation of Conditional Cash Transfers to Increase Retention in PMTCT Services in Akwa Ibom State, Nigeria
A randomized controlled trial will be conducted to assess the effectiveness of conditional cash transfers (CCTs) at increasing retention in prevention of mother-to-child transmission (PMTCT) services specifically, in relation to…
- Conditions
- HIV, HIV Infections, Pregnancy, Infant, Newborn, Diseases
- Trial name
- NCT02447159
- Testing
- Conditional Cash Transfers
- Where
- 3 sites in Nigeria
- Volunteers
- 554 people
- Sponsor
- University of California, San Francisco
Newborn Infant, Newborn Health
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
During intrauterine life, the fetus is connected to the mother via the placenta; with birth, the extrauterine adaptation process begins.
- Conditions
- Newborn Infant, Newborn Health, Delayed Cord Clamping
- Trial name
- Cord Clamping (NCT07719751)
- Testing
- Prone position, Left side lying position
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mersin University