Clinical trials: Infant, Newborn, Diseases
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
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.
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 (& [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
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
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
Hypoxemia, Neonatal Disease
Evaluation of a Multi-country Medical Oxygen Program
REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for…
- Conditions
- Hypoxemia, Neonatal Disease, Pneumonia, Sepsis
- Trial name
- REAL-MOXY (NCT06087315)
- Testing
- Multi-faceted oxygen systems strengthening interventions (different for each country)
- Where
- 3 sites in Cambodia, Nigeria and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Murdoch Childrens Research Institute
Hyper Bilirubinemia, Premature Infant
Cycled Phototherapy
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA).
- Trial name
- NCT03927833
- Testing
- Phototherapy lights
- Where
- 19 sites in United States
- Volunteers
- 1,700 people
- Sponsor
- NICHD Neonatal Research Network
Newborn, Infant, Disease, Neurodevelopmental Disorders
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty
Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal…
- Trial name
- miniNO-COVID (NCT04952870)
- Testing
- Inhaled NO, routine care
- Where
- 2 sites in France, Greece
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille
Infant, Premature, Patent Ductus Arteriosus
Management of the PDA Trial
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
- Conditions
- Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
- Trial name
- PDA (NCT03456336)
- Testing
- Active Treatment, Expectant Management
- Where
- 19 sites in United States
- Volunteers
- 482 people
- Sponsor
- NICHD Neonatal Research Network
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital