Clinical trials: Very Low Birth Weight
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Very Low Birth Weight Infant, Respiratory Distress Syndrome in Premature Infant
Enteral Nutrition Tolerance And REspiratory Support (ENTARES)
This research study aims to evaluate the relation between non-invasive ventilation and feeding tolerance in preterms with respiratory distress syndrome (RDS).
- Conditions
- Very Low Birth Weight Infant, Respiratory Distress Syndrome in Premature Infant, Enteral Feeding Intolerance
- Trial name
- ENTARES (NCT03548324)
- Testing
- HHHFNC, NCPAP
- Where
- 13 sites in Italy
- Volunteers
- 280 people
- Sponsor
- University of Turin, Italy
Hypotension, Very Low Birth Weight Infants
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life
The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants.
- Conditions
- Hypotension, Very Low Birth Weight Infants, Ventricular Dysfunction, Prematurity
- Trial name
- NCT00425581
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Very Low Birth Weight Baby
Serum Folic Acid Levels in Preterm Infants
Therefore preterm infants must need folic acid replacement than term babies.
- Trial name
- FALIPI (NCT01360528)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Mehmet Yekta
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
Bronchopulmonary Dysplasia (BPD), Prematurity
Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Prematurity, Very Low Birth Weight
- Trial name
- VITA-BPD (NCT07577180)
- Testing
- Vitamin A
- Where
- Turkey (Türkiye)
- Volunteers
- 209 people
- Sponsor
- Erhan Calisici
Very Low Birth Weight Infant
Fluid Balance Study in Sick Neonates
The purpose of this study is to determine if routinely recording fluid balance in sick neonates admitted to the pediatric ward is reliable and useful. The investigators' hypothesis is that it is not useful and reliable.
- Trial name
- NCT00962754
- Testing
- physician no insight in the fluid balance chart
- Where
- Netherlands
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Princess Amalia Children's Clinic
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Infection
Dynamics of the Microbiome in the Premature Infant
The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.
- Trial name
- NCT02121938
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
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
Oral Colostrum Administration in Very Low Birth Weight Premature Infants
Analysis of the Effects of Oral Colostrum Administration in Premature Infants on the Breastfeeding
In the literature, it is emphasized that oral colostrum administration in very low birth weight infants supported the immune development of the premature newborn, contributed to the development of oral microbiota and reduced the…
- Trial name
- Oral colostrum (NCT04454502)
- Testing
- Oral colostrum administration
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Sakarya University
Prone Positioning, Bronchopulmonary Dysplasia
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as assessed at 36 weeks post…
- Trial name
- NCT04890158
- Testing
- Prone positioning for a total of 6 hours daily
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Very Low Birth Weight Infant
Pharmacokinetic Study of Fluconazole in Premature Infants
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
- Trial name
- NCT01683760
- Testing
- Fluconazole
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Seoul National University Hospital
Preterm Birth
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation.
- Trial name
- NCT00128141
- Testing
- Tactile stimulus
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- National Bioethics Commission of Brazil
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
Prematurity, Oxidant Injury
Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants
We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and…
- Trial name
- NCT00369720
- Testing
- Titration of oxygen in delivery room
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Neil Finer
Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn
The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants
This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm…
- Conditions
- Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn, Neonatal Mortality
- Trial name
- NCT06729398
- Testing
- NIRS, SafeboosC
- Where
- Indonesia
- Volunteers
- 129 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Necrotizing Enterocolitis
Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to August 2012.
- Trial name
- NCT01868737
- Testing
- Probiotic
- Where
- South Africa
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch