Clinical trials: Very Low Birth Weight
Necrotizing Enterocolitis, Sepsis
Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.
- Trial name
- NCT00835874
- Testing
- Probiotics
- Where
- Israel
- Volunteers
- 57 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
CGM Use in Preterm Infants
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia
- Trial name
- NCT05436925
- Testing
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Minnesota
Very Low Birthweight Infants, Mother Child Interaction
Delivery Room Skin-to-skin Study
The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin…
- Conditions
- Very Low Birthweight Infants, Mother Child Interaction, Preterm Infant
- Trial name
- deisy (NCT01959737)
- Testing
- skin-to.skin-contact
- Where
- Germany
- Volunteers
- 88 people
- Sponsor
- University of Cologne
Liver Disease
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates.
- Trial name
- NCT02947594
- Volunteers
- 37 people
- Sponsor
- Università Politecnica delle Marche
Very Preterm Birth
High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth
This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach…
- Trial name
- NCT06909929
- Testing
- Lipid IV 2 g, lipid IV 1 gram
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Transfusion, Feeding During Transfusion
Withholding Feeds During Red Blood Cell Transfusion and TRAGI
Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns.
- Conditions
- Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis
- Trial name
- Tx-TRAGI (NCT02132819)
- Testing
- Withholding feeds, feeding during transfusion
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore
Health Behavior
Oropharyngeal Administration of Colostrum
Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection.
- Trial name
- NCT02912585
- Testing
- Oropharyngeal administration of own mother's colostrum, Oropharyngeal administration of donor human milk
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Federal University of Uberlandia
Infant, Newborn, Infant, Low Birth Weight
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- IVIG (NCT01203345)
- Testing
- IVIG
- Where
- 8 sites in United States
- Volunteers
- 2,416 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Very Low Birth Weight
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants
- Trial name
- NCT01799629
- Testing
- Glycerin suppositories
- Where
- 3 sites in Saudi Arabia
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- King Faisal Specialist Hospital & Research Center
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
Premature Birth, Perinatal Mortality
Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands
The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the…
- Conditions
- Premature Birth, Perinatal Mortality, Infant, Low Birth Weight, Stillbirth
- Trial name
- NCT02189265
- Testing
- Smoke-free legislation
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 2,069,695 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Infant; Premature, Light-For-Dates
Nephrocalcinosis in Very Low Birth Weight Infants
Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis.
- Trial name
- NCT04860583
- Testing
- Renal ultrasound
- Volunteers
- 265 people
- Sponsor
- Hospices Civils de Lyon
Indirect Hyperbilirubinemia
Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants
Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S.
- Trial name
- NCT01411761
- Testing
- Reflor, serum physiologic
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Meconium Obstruction of Prematurity
Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction
Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC).
- Trial name
- NCT02864446
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Seoul National University 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
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, Very Low Birth Weight, Calcium Deficiency
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
- Conditions
- Infant, Very Low Birth Weight, Calcium Deficiency, Vitamin D Deficiency
- Trial name
- NCT01363167
- Testing
- 400 IU Cholecalciferol- Vitamin D Daily
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- Medical University of South Carolina
Infant, Newborn, Infant, Low Birth Weight
Physiologic Definition of Bronchopulmonary Dysplasia
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PhysiologicDef (NCT01223287)
- Where
- 21 sites in United States
- Volunteers
- 410 people
- Sponsor
- NICHD Neonatal Research Network
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)