Clinical trials: Low; Birthweight
Very Low Birth Weight Infant
Flexible Electronics for Early Assessment
The morbidities associated with very low birth weight (VLBW) infants constitute a major health problem and a significant emotional and financial burden for families and our nation.
- Trial name
- NCT03034785
- Testing
- FlexiMitt
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Wyss Institute at Harvard University
Insulin Resistance, Low Birth Weight
Effects of 3 Months of Selective Serotonin Reuptake Inhibitor (SSRI)-Treatment on Metabolism and Hypothalamic-pituitary-adrenal (HPA)-Axis in Young Men Born With Low Birth Weight
Chronic stress has been proposed to be involved the development of western life-style diseases such as cardiovascular disease and type 2 diabetes (T2DM).
- Conditions
- Insulin Resistance, Low Birth Weight, Type 2 Diabetes, Cardiovascular Disease
- Trial name
- LBW-SSRI (NCT00971815)
- Testing
- Escitalopram
- Where
- Denmark
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Low-Birth-Weight Infant, Breast Feeding
Finger Feeding as a Method of HMF Supplementation After Discharge
Human Milk Fortifier (HMF) is designed to supply additional calories, protein, vitamins and minerals to infants less than 37 weeks gestation or those less than 1500 g at birth.
- Trial name
- NCT04036240
- Testing
- Finger feeding
- Where
- 4 sites in Indonesia
- Volunteers
- 78 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
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
Infant, Newborn, Infant, Low Birth Weight
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- STOP-ROP (NCT01203436)
- Testing
- Supplemental Oxygen Management, Conventional Oxygen Management
- Where
- 9 sites in United States
- Volunteers
- 649 people
- Sponsor
- NICHD Neonatal Research Network
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
Very Low Birth Weight Infants
Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization.
- Trial name
- NCT01531192
- Testing
- Lactobacillus reuteri, Nystatin
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Bronchopulmonary Dysplasia
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.
- Trial name
- MiBPD (NCT03229967)
- Testing
- 16S rRNA stool microbiome sequencing.
- Where
- 2 sites in United States
- Volunteers
- 197 people
- Sponsor
- University of Tennessee
Low Birth Weight, Premature Birth
Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital
The goal of this clinical trial is to learn whether early initiation of kangaroo mother care (KMC) can improve clinical outcomes in healthy low birth weight preterm neonates (gestational age 30-37 weeks, birth weight <2000 g).
- Conditions
- Low Birth Weight, Premature Birth, Preterm Infant
- Trial name
- NCT07259486
- Testing
- Kangaroo Mother Care, Standard Medical Care (SMC)
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- University of Health Sciences Lahore
Preterm Birth
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation.
- Trial name
- NCT00128141
- Testing
- Tactile stimulus
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- National Bioethics Commission of Brazil
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
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
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, Low Birth Weight, Anemia
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.
- Trial name
- EPO (NCT00593801)
- Testing
- epoetin beta
- Where
- Germany
- Volunteers
- 219 people
- Sponsor
- Charite University, Berlin, Germany
Low Birth Weight, Premature Birth
Social Adjustment and Quality of Life After Very Preterm Birth
The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500 birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27 years.
- Trial name
- NCT01163188
- Where
- Germany
- Volunteers
- 520 people
- Sponsor
- University Hospital, Bonn
Extremely Low Birth Weight
Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.
- Trial name
- NCT00850902
- Testing
- High Humidity (HH), Moderate Humidity
- Volunteers
- 700 people
- Sponsor
- King Fahad Medical City
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
Weight Gain Preterm
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely.
- Trial name
- SPN (NCT01217164)
- Testing
- no intervention
- Where
- Brazil
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Pedro Ernesto
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.