Clinical trials: Very Low Birthweight Infants
Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Trial name
- NCT05022433
- Testing
- UVC insertion
- Where
- Singapore
- Volunteers
- 170 people
- Sponsor
- Singapore General Hospital
Infant, Newborn, Infant, Low Birth Weight
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Preemie iNO (NCT00016523)
- Testing
- Inhaled nitric oxide
- Where
- 17 sites in United States
- Volunteers
- 420 people
- Sponsor
- NICHD Neonatal Research Network
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
Plagiocephaly
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing < 1…
- Trial name
- NCT03184441
- Testing
- Premie Pouch
- Where
- 3 sites in United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
Premature Infant, Respiratory Distress Syndrome in Premature Infant
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before…
- Conditions
- Premature Infant, Respiratory Distress Syndrome in Premature Infant, Neurodevelopmental Outcome
- Trial name
- HiLo (NCT03825835)
- Testing
- 30% oxygen group, 60% oxygen group
- Where
- 14 sites in Canada, Ireland
- Volunteers
- 1,203 people
- Sponsor
- University of Alberta
Infant, Newborn, Infant, Low Birth Weight
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EPO (NCT01203514)
- Testing
- Erythropoietin
- Where
- 9 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Trophic Feeding, Very Low Birth Weight Baby
Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants
The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally every 4 and 2 hours in order to achieve trophic feeding in preterm infants.
- Conditions
- Trophic Feeding, Very Low Birth Weight Baby, Preterm
- Trial name
- NCT06379178
- Testing
- Oral colostrum application 2 hours, Oral colostrum application 4 hours
- Where
- Indonesia
- Volunteers
- 47 people
- Sponsor
- Gadjah Mada University
Respiratory Distress Syndrome, Newborn, Respiratory Tract Diseases
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal…
- Trial name
- NCT02340299
- Testing
- nHFOV, nCPAP
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- Charite University, Berlin, Germany
Hypothyroxinemia
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.
- Trial name
- NCT00565890
- Testing
- thyroxine
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Tokyo Women's Medical University
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
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
Very Low Birth Weight Infants
Efficacy of Multiple Strain Probiotics Reduces the Neurobehavioral Disorder in Premature Very Low Birth Weight Infants
The management protocols, clinical practices, equipment, infrastructure, and key personnel in NICU are unchanged during the study period.
- Trial name
- NCT03858816
- Testing
- Mixture probiotics
- Where
- Taiwan
- Sponsor
- China Medical University Hospital
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 gr.
- Trial name
- NCT01315821
- Testing
- Saccharomyces boulardii
- Where
- Turkey (Türkiye)
- Volunteers
- 220 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Atopic Dermatitis
Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants
The purpose of this study is assess if the use of probiotic in very low weight could be other benefits a long time, as reduce atopic disease in this children.
- Trial name
- NCT06035835
- Testing
- Lacticaseibacillus rhamnosus, Lactobacillus acidophilus + Bifidobacterium bifidum
- Volunteers
- 437 people
- Sponsor
- José Uberos Fernández
Infant, Very Low Birth Weight
Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding
The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns in preterm infants. It will be a randomized blind study.
- Trial name
- NCT00703950
- Testing
- cup feeding, bottle feeding
- Where
- Brazil
- Volunteers
- 56 people
- Sponsor
- Instituto Fernandes Figueira
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
Very Low Birth Weight Infants
Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants
Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections.
- Trial name
- NCT01443091
- Testing
- application of mother's own colostrum, application of sterile water
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center