Clinical trials: Very Preterm Infant
Very Low Birth Weight Infant, Ureaplasma/Mycoplasma Positive
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.
- Trial name
- NCT01851954
- Testing
- Clarithromycin
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Seoul National University Hospital
Respiratory Distress Syndrome, Newborn
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always…
- Trial name
- NCT02267018
- Testing
- Drager VN500 Ventilator
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Patent Ductus Arteriosus
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that…
- Trial name
- NCT00728117
- Testing
- feeding, fasting
- Where
- 14 sites in United States
- Volunteers
- 177 people
- Sponsor
- University of California, San Francisco
Respiratory Distress Syndrome in Premature Infant
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better.
- Trial name
- NEOSURF (NCT07098910)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA), Intubation - Surfactant administration - Extubation (INSURE)
- Where
- Vietnam
- Volunteers
- 440 people
- Sponsor
- Karolinska Institutet
Extubation Failure
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
- Trial name
- NCT00979433
- Testing
- Bubble CPAP, Conventional CPAP
- Where
- India
- Volunteers
- 32 people
- Sponsor
- All India Institute of Medical Sciences
Immunomodulation Effect
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was…
- Trial name
- NCT05087498
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- Phototherapy (NCT00114543)
- Testing
- Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g, Conservative Phototherapy 501-750g
- Where
- 17 sites in United States
- Volunteers
- 1,974 people
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant
Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP) with 47% of all CP cases occurring in infants with birth weight less than 2500 g.
- Trial name
- Cordmilking (NCT02987764)
- Testing
- cord milking
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, Los Angeles
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Bronchopulmonary Dysplasia
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.
- Trial name
- MiBPD (NCT03229967)
- Testing
- 16S rRNA stool microbiome sequencing.
- Where
- 2 sites in United States
- Volunteers
- 197 people
- Sponsor
- University of Tennessee
Necrotizing Enterocolitis
Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with the diagnosis of preterm (<33 weeks…
- Trial name
- Probiotics (NCT02650869)
- Testing
- Probiotics, Breast milk
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sylhet M.A.G.Osmani Medical College
Meconium Ileus
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants
Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours).
- Trial name
- NCT02140710
- Testing
- Osteopathic treatment
- Where
- Austria
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Necrotizing Enterocolitis (NEC)
Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation.
- Trial name
- NCT06810154
- Testing
- Multi-strain probiotics
- Where
- 4 sites in Canada
- Volunteers
- 2,170 people
- Sponsor
- University of Calgary
Very Low Birth Weight Baby, Premature Birth
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in…
- Conditions
- Very Low Birth Weight Baby, Premature Birth, Microbial Colonization, Oxidative Stress
- Trial name
- NCT03214822
- Testing
- H2MF
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, Diseases
- Trial name
- NeOProM (NCT01124331)
- Testing
- Higher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)
- Where
- 9 sites in Australia
- Volunteers
- 4,965 people
- Sponsor
- University of Sydney
Infant, Premature, Infant, Very Low Birth Weight
Testosterone and Cortisol Levels in Infants
Very low birth weight (VLBW) infants have more health and developmental problems than normal birth weight full-term infants. These problems are more common in males than female VLBW preterm infants.
- Trial name
- NCT02599545
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Duke University
Premature Birth of Newborn
Body Composition at Discharge and Neurological Development at 2 Years in Very Preterm Infants (OPTIPREMA)
This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development.
- Trial name
- OPTIPREMA (NCT02686801)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Hôpital de la Croix-Rousse
Bacteria Infection, Respiratory Tract Infections
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection…
- Trial name
- NCT00599053
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Alabama at Birmingham
Procedural Pain, Pre-Term
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
The management of pain related to venipuncture remains insufficient in very preterm infants (VPI. The separation between the mother (father) and her(his) child can aggravate the short-term painful experience of the newborn.
- Conditions
- Procedural Pain, Pre-Term, Venipuncture
- Trial name
- NOCI-Prem (NCT05404594)
- Testing
- Maternal vocal contact
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Neonatal Disease
Effect of DHA on Proinflammatory Cytokines Including Platelets Activating Factor (PAF) in Preterm Neonates
The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis in preterm/low birth weight neonates.Necrotizing enterocolitis (NEC) is the…
- Trial name
- NCT04746885
- Testing
- DHA
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Ain Shams University