Clinical trials: Preterm, Infant
Complication Due to Immunization
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE).
- Trial name
- NCT02726178
- Testing
- Advil® Pediatric drops for infants
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Prematurity, Very Low Birth Weight
The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants
The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.
- Trial name
- NCT00593684
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in…
- Conditions
- Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia, Premature Lungs
- Trial name
- NCT06609135
- Testing
- Sentec LuMon Device (EIT system), Sentec Digital Monitoring System (transcutaneous CO2 monitor)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Lawrence Rhein
Infant Development, Stress
Multisensory Early Oral Administration of Human Milk in Preterm Infants
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation.
- Trial name
- M-MILK (NCT06230848)
- Testing
- Multisensory Early Oral Administration of Human Milk (M-MILK)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Loyola University
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Vitamin D Deficiency, Nutritional Deficiency
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet…
- Trial name
- MoMO PIP (NCT04629534)
- Testing
- High dose Cholecalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Medical University of South Carolina
Respiratory Distress Syndrome
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb.
- Trial name
- NCT02392806
- Testing
- Bubble CPAP- BabiPlus, Respiralogics, Bubble CPAP- B&B Bubbler, B&B Medical devices
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Marya Strand, MD
Infant, Newborn, Infant, Moderate Preterm
Incubator Weaning of Moderately Preterm Infants
The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
- Trial name
- NCT02160002
- Testing
- Weaning from an incubator at a lower weight (1600 grams), Weaning from an incubator at a higher weight (1800 grams)
- Where
- 18 sites in United States
- Volunteers
- 366 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the…
- Trial name
- NEOSURF (NCT02834624)
- Testing
- Poractant alfa, calfactant
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Missouri-Columbia
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Prematurity, Intestinal Permeability
Intestinal Permeability in Preterm Infants
Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency characterized by increased intestinal permeability, affects approximately 7 to 10% of infants <1500 g birthweight, and typically occurs within 7 to…
- Trial name
- IPPI (NCT01756040)
- Testing
- Lactulose -rhamnose solution
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- University of Maryland, Baltimore
Prematurity
Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity.
- Trial name
- BRITE (NCT01207778)
- Where
- 3 sites in United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
Respiratory Distress Syndrome, Newborn
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the…
- Trial name
- NCT02452476
- Testing
- CHF5633, Poractant alfa
- Where
- 23 sites in United States
- Volunteers
- 123 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Apnea of Prematurity, Intraventricular Hemorrhage
MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine
Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems.
- Conditions
- Apnea of Prematurity, Intraventricular Hemorrhage, Brain Injury
- Trial name
- NCT00809055
- Testing
- Caffeine citrate
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Washington University School of Medicine
Neonatal, Premature Birth
Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function
This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as…
- Conditions
- Neonatal, Premature Birth, Respiratory Distress Syndrome
- Trial name
- NCT04295564
- Testing
- Additional 2 weeks of CPAP
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cynthia McEvoy
Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants
Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in…
- Trial name
- NCT01877720
- Testing
- noninvasive respiratory support with NAVA mode and PSV
- Where
- 3 sites in South Korea
- Volunteers
- 16 people
- Sponsor
- Seoul National University Hospital
Premature Birth of Newborn
Effects of Massage Therapy to Induce Sleep in Preterm Infants
Premature infants sometimes require sedation to ensure minimal movement during diagnostic procedures such as MRIs. However, sedatives may produce adverse effects.
- Trial name
- NCT01354028
- Testing
- Massage therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Arkansas
Bronchopulmonary Dysplasia
Inhaled Tobramycin in BPD
This study is an open-label, phase 1, sequential dose escalation trial seeking to establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different doses of inhaled tobramycin administered to very…
- Trial name
- NCT04560179
- Testing
- Tobramycin solution for inhalation 78mg dose, Tobramycin solution for inhalation 150mg dose, Tobramycin solution for inhalation 216mg dose
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Erik Allen Jensen
Respiratory Distress Syndrome, Newborn
Aerosolized Surfactant in Neonatal RDS
Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants.
- Trial name
- AS-02 (NCT02294630)
- Testing
- Surfactant
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Sood, Beena G., MD, MS