Clinical trials: Very Low Birth Weight Infant
Osteopenia of Prematurity
The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT01042639
- Testing
- passive physical activity
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Meir Medical Center
Safety Issues, Tolerance
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants.
- Conditions
- Safety Issues, Tolerance, Very Low Birth Weight Infant
- Trial name
- NCT03163212
- Testing
- Lactoferrin/FOS
- Volunteers
- 20 people
- Sponsor
- University of Virginia
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
Preterm Infants, Respiratory Distress Syndrome
Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard…
- Conditions
- Preterm Infants, Respiratory Distress Syndrome, CPAP, RAM Cannula
- Trial name
- NCT03121781
- Testing
- respiratory support- interface
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
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
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
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
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
Early DHA Supplementation in Very Low Birth Weight Infants
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
- Trial name
- NCT03192839
- Testing
- Low dose PUFA, High dose PUFA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mead Johnson Nutrition
Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against
Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition
This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification.
- Conditions
- Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against, Allergy, Dietary Modification
- Trial name
- NCT02078687
- Testing
- Enfamil HM fortifier, Mead Johnson, Enfalac Premature Formula, Mead Johnson Nutritionals, Mothers own milk
- Where
- Denmark
- Volunteers
- 239 people
- Sponsor
- University of Southern Denmark
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Premature Infants, Very Low Birth Weight Infants
The Video System to Provide a Developmental Training Guide for Preterm Infants
This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy…
- Trial name
- NCT06965842
- Testing
- Parent-centered developmental training
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Hospital
Infant, Very Low Birth Weight
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant.
- Trial name
- NICU (NCT01204983)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Baylor College of Medicine
Infant Development, Infant,Premature
Movement-based Infant Intervention
The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay.
- Conditions
- Infant Development, Infant,Premature, Infant, Very Low Birth Weight, Infant, Small for Gestational Age
- Trial name
- NCT03082313
- Testing
- Movement Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Southern California
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Baby
Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement.
- Trial name
- DSC (NCT02817022)
- Testing
- developmentally supportive care
- Where
- 2 sites in India
- Volunteers
- 120 people
- Sponsor
- Lady Hardinge Medical College
Infant, Very Low Birth Weight, Infant Development
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group).
- Conditions
- Infant, Very Low Birth Weight, Infant Development, Feeding Patterns
- Trial name
- NCT06569186
- Testing
- Cue-based feedings
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Intervention
Effect of Developmental Care on Very Low Birth Weight Infants
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are: Does developmental care shorten the length of hospital stay in…
- Trial name
- NCT06515574
- Testing
- developmental care
- Where
- 2 sites in China
- Volunteers
- 1,600 people
- Sponsor
- Children's Hospital of Fudan University
Low Birth Weight Infant
Platelet-activating Factor Acetylhydrolase (Paf-ah) Gene Expression
This is a prospective observational study to determine whether there is an association between the presence of platelet-activating factor acetylhydrolase (PAF-AH) gene polymorphisms and the development of chronic lung disease in…
- Trial name
- NCT00747240
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- University of Utah