Clinical trials: Very Low Birthweight Infants
Sepsis
Impact of Heart Rate Characteristics Monitoring in Neonates
Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.
- Trial name
- HeRO (NCT00307333)
- Testing
- HeRO heart rate characteristics monitor
- Where
- 8 sites in United States
- Volunteers
- 3,003 people
- Sponsor
- University of Virginia
Human Milk, Neonate
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth.
- Conditions
- Human Milk, Neonate, Breast Milk
- Trial name
- NCT04025021
- Testing
- Targeted Fortification, The Miris Human Milk Analyzer
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MetroHealth Medical Center
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island
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
Iron Deficiency Anemia
Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine…
- Trial name
- NCT01125163
- Testing
- Iron Supplement, multivitamin
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
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
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, 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
Sleep, Pregnancy
Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02379728
- Testing
- PrenaBelt, Body Position Sensor
- Where
- Ghana
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
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
Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.
- Trial name
- NCT05949788
- Testing
- No intervention
- Where
- China
- Volunteers
- 146 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Infant Respiratory Distress Syndrome, Respiratory Insufficiency
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
- Conditions
- Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
- Trial name
- NCT00296231
- Testing
- Nasal high frequency ventilation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Tarah T Colaizy
Staphylococcal Sepsis
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants.
- Trial name
- NCT00646399
- Testing
- Pagibaximab 50 mg/mL
- Where
- United States
- Volunteers
- 1,579 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
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