Clinical trials: Very Low Birthweight Infants
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization.
- Trial name
- NCT01411748
- Testing
- Reflor, mikostatin
- Where
- Turkey (Türkiye)
- Volunteers
- 140 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
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
Infant Development
Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in VLBW Infants Using Quantitative NIRS
The study quantified functional measures of red blood cell mass and oxygen in neonatal tissues using a non-invasive optical technique: near infrared optical spectroscopy .
- Trial name
- NCT00544375
- Testing
- Optical measurement
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of California, Irvine
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
Inadequate; Pulmonary Ventilation, Newborn, Infant, Very Low Birth Weight
Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely.
- Trial name
- NCT01785563
- Testing
- Nasal NIV-NAVA
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tarah T Colaizy
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
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
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
Neonatal Respiratory Distress, Very Low Birth Weight Infant
PRICO: OPTI Target Range
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
- Trial name
- POSTR (NCT06207994)
- Testing
- Narrow TR, Shifted TR
- Where
- Czechia
- Volunteers
- 11 people
- Sponsor
- Czech Technical University in Prague
Anemia
Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.
- Trial name
- NCT01224236
- Testing
- Iron Supplement, control
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Iron Deficiency, Anemia of Prematurity
Neurodevelopment After Early Iron Supplementation
Background: Iron deficiency in early childhood may impair neurodevelopment. Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.
- Conditions
- Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay
- Trial name
- NCT00457990
- Testing
- Oral administration of ferrous sulphate
- Where
- Germany
- Volunteers
- 204 people
- Sponsor
- University of Ulm
Bronchopulmonary Dysplasia, Very Low Birth Weight
Preterm Infant Inhaled Albuterol Dosing
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD).
- Trial name
- NCT02447250
- Testing
- Varied albuterol dose response
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Oregon Health and Science University
Infant, Newborn, Infant, Low Birth Weight
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Benchmarking (NCT00067613)
- Testing
- Benchmarking Management Practices, Standard Management Practices
- Where
- 17 sites in United States
- Volunteers
- 4,095 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network