Clinical trials: Very Low Birth Weight Infant
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Anemia of Prematurity, Very Low Birth Weight Infant
Iron Supplementation and Intestinal Health
This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation.
- Trial name
- NCT04497012
- Testing
- 2mg/kg/day Iron Sulfate, 6 mg/kg/day Iron Sulfate
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Extra Uterine Growth Restriction, Premature Infant Disease
Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds.
- Conditions
- Extra Uterine Growth Restriction, Premature Infant Disease, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT06731439
- Testing
- Starting feeds within 6 hours of life, Standard feeding protocol
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- University of Tennessee
Preterm Infant, Very Low Birth Weight Infant
Lactoferrin Infant Feeding Trial - LIFT_Canada
This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the…
- Conditions
- Preterm Infant, Very Low Birth Weight Infant, Morbidity;Newborn
- Trial name
- NCT03367013
- Testing
- Bovine Lactoferrin, No Bovine Lactoferrin added
- Where
- 9 sites in Canada
- Volunteers
- 453 people
- Sponsor
- Dr. Elizabeth Asztalos
Very Low Birth Weight Infant
The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.
- Trial name
- NCT06550440
- Testing
- family integrated care
- Where
- China
- Volunteers
- 1,255 people
- Sponsor
- Children's Hospital of Fudan University
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
Very Low Birth Weight Infant, Growth Failure
Targeted Fortification of Pasteurized Donor Human Milk
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs).
- Conditions
- Very Low Birth Weight Infant, Growth Failure, Donor Breast Milk
- Trial name
- NCT04640805
- Testing
- Protein supplementation, Analysis with Miris Human Milk Analyzer
- Where
- Singapore
- Volunteers
- 61 people
- Sponsor
- KK Women's and Children's Hospital
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
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Very Low Birth Weight Infant, Nutritional Deficiency
Enteral Zinc Supplementation in Very Low Birth Weight Infants
The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc.
- Trial name
- NCT06433674
- Testing
- Zinc Sulfate, Sterile Water
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Tennessee
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
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
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Very Low Birth Weight Infant
Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023
The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight.
- Trial name
- NUMETA (NCT06200324)
- Testing
- Ready-to-Use Parenteral Nutrition
- Where
- Colombia
- Volunteers
- 284 people
- Sponsor
- Fundacion Clinica Valle del Lili
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 Development, Sensory Disorder
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay
- Trial name
- highrisk (NCT05217199)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Very Low Birth Weight Infant, Placental Transfusion
Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section.
- Conditions
- Very Low Birth Weight Infant, Placental Transfusion, Anemia
- Trial name
- EXPLAIN (NCT03916159)
- Testing
- Extrauterine placental transfusion (Intervention group), Delayed cord clamping (Control group)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Universitätsklinikum Köln
Very Low Birth Weight Infant
The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants
This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit…
- Trial name
- NCT05483231
- Testing
- Family integrated care intervention group, Routine nursing care group
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Children's Hospital of Fudan University
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
USCOM Parameters in Preterm Infants: Reference Ranges
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants.
- Trial name
- NCT05961657
- Testing
- Hemodynamic measurements by USCOM
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori