Clinical trials: Very Low Birthweight Infants
Breast Milk, Premature Infant
Individualized Fortification of Breast Milk
Objectives: To compare the effects of two different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants.
- Trial name
- NCT03324126
- Volunteers
- 32 people
- Sponsor
- Ozgul Bulut
Tissue Oxygenation
Tissue Oxygen Deprivation as Detected With Raman in Association With Umbilical Artery Catheters
Umbilical artery catheters (UACs) are associated with significant morbidity in preterm neonates however are necessary for the management of this high risk population.
- Trial name
- NCT04038203
- Testing
- Resonance Raman Spectroscopy (RPS)
- Where
- United States
- Sponsor
- University of Florida
Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance
Clinical Tolerance of Numeta 13%
Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral nutrition is not possible, insufficient or contra…
- Conditions
- Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance, Disorder of Mineral Metabolism, Failure to Thrive
- Trial name
- BAXTERULG2 (NCT01772927)
- Testing
- Parenteral Nutrition
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University of Liege
Very Low Birth Weight Infant, Weight Gain
Effect of Milk Warming on the Very Low Birth Weight Infant
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks…
- Conditions
- Very Low Birth Weight Infant, Weight Gain, Feeding Disorder Neonatal
- Trial name
- VLBW (NCT04282655)
- Testing
- Treatment Guardian Milk Warmer (Medela TM), Control
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
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
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
Very Low Birth Weight Infant, Premature Infants
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children
- Trial name
- NCT06555315
- Testing
- 6 mg/kg of oral iron as ferrous sulfate administered every other day., 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CHRISTUS Health
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
Infant, Very Low Birth Weight, Growth Failure
Preterm Infants on Early Solid Foods
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates.
- Trial name
- PIES-Project (NCT01809548)
- Testing
- Early intervention group, Late intervention group
- Where
- Austria
- Volunteers
- 177 people
- Sponsor
- Medical University of Vienna
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
Necrotizing Enterocolitis
Infloran® for Prevention of Necrotizing Enterocolitis
Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity.
- Trial name
- NCT01751477
- Where
- 2 sites in Austria
- Volunteers
- 463 people
- Sponsor
- Medical University of Vienna
Infant, Newborn, Infant, Low Birth Weight
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Glutamine (NCT00005775)
- Testing
- Glutamine
- Where
- 15 sites in United States
- Volunteers
- 1,433 people
- Sponsor
- NICHD Neonatal Research Network
Premature Infant, Non-invasive Respiratory Support
Feeding Premature Infants During Non-invasive Respiratory Support
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support
- Trial name
- NCT03852641
- Testing
- Length of feeding
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus
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
Postnatal Growth Failure of Preterm Infants, Human Milk Fortification
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native…
- Trial name
- NCT02716337
- Testing
- Addition of human milk fortifiers according to human milk analysis
- Volunteers
- 10 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Respiratory Infections
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Acute respiratory infections are the leading cause of hospitalization in premature infants worldwide. Severity rates are particularly high in developing countries.
- Trial name
- NCT01390753
- Testing
- Human donor milk
- Where
- Argentina
- Volunteers
- 300 people
- Sponsor
- Fundacion Infant
Infant, Very Low Birth Weight, Infant Malnutrition
Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants
This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10…
- Conditions
- Infant, Very Low Birth Weight, Infant Malnutrition, Feeding Disorder of Infancy or Early Childhood, Splanchnic Oximetry
- Trial name
- NCT01341236
- Testing
- different nutrional regimen, comparison of different feeding regimens
- Where
- Italy
- Volunteers
- 41 people
- Sponsor
- San Gerardo Hospital
Preterm Birth, Very Low Birth Weight Infant
Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program.
- Conditions
- Preterm Birth, Very Low Birth Weight Infant, Early Intervention, Parent-Child Relations
- Trial name
- NCT05399667
- Testing
- Early stimulation, Conventional care
- Where
- Brazil
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Prematurity, VLBW - Very Low Birth Weight Infant
Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
Premature very low birth weight (VLBW) infants were placed in two groups matched for birth age. The control group received traditional joint compression exercises designed to decrease bone density loss.
- Trial name
- NCT03884322
- Testing
- Prepod, Joint compression exercises
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Asante Health System