Clinical trials: Very Low Birthweight Infants
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Premature Birth
Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
- Trial name
- NCT02628015
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- University of Bonn
Very Low Birth Weight Infant
Comparison of Early Versus Late Trophic Feeding
Local data on the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay is scarce.
- Trial name
- NCT07229885
- Testing
- Early trophic feeding, Late trophic feeding
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- RESnTEC, Institute of Research
Infant, Premature, Nutrition, Enteral
Aspiration of Residual Gastric Contents
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
- Trial name
- NCT01863043
- Testing
- No aspiration of gastric contents, Routine aspiration of gastric contents
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- University of Florida
Other Preterm Infants, NEC
Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study
This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight…
- Trial name
- NCT02192996
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Hospital Universitario La Paz
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g.
- Trial name
- NCT01531179
- Testing
- Lactobacillus reuteri
- Where
- Turkey (Türkiye)
- Volunteers
- 400 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Low Birth Weight Baby, Very Low Birth Weight Baby
Home-based Interventional Program on Low Birth Weight Baby Care
The goal of this interventional study is to evaluate whether a home-based interventional program for mothers can improve their knowledge and performance in caring for their low birth weight baby at home.
- Trial name
- (HBEP-LBWC) (NCT07482904)
- Testing
- Home-based Interventional group
- Where
- Iraq
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Chawarwan Saleem Abdullah
Preterm Infants
Bifidobacterium Supplementation for Very Low Birth Weight Infants
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum…
- Trial name
- Bifido(RCT) (NCT01375309)
- Testing
- Bifidobacterium bifidum supplementation
- Where
- Japan
- Volunteers
- 246 people
- Sponsor
- Tokyo Women's Medical University
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
Birth Asphyxia, Very Low Birth Weight Baby
Naushero Feroze Neonatal Survival Project
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan.
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Trial name
- AKU (NCT01350765)
- Testing
- Intervention, Control
- Where
- Pakistan
- Volunteers
- 37,201 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Infant, Very Low Birth Weight
High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants
The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low…
- Trial name
- NCT03374033
- Testing
- NUTR +, STIMUL +
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Università Politecnica delle Marche
Nutrition Disorder, Infant
Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants
A single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was…
- Trial name
- PUMPA (NCT04085484)
- Testing
- More concentrated parenteral nutrition solution
- Where
- Sweden
- Volunteers
- 134 people
- Sponsor
- Umeå University
BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis
Targeted vs Standard Fortification of Breast Milk
BACKGROUND: Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW.
- Conditions
- BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis, Weight Gain, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT03775785
- Testing
- Tailored enteral nutrition
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
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
Pre-Term, Persistent Ductus Arteriosus
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus
- Trial name
- NCT04295395
- Testing
- NONIN SenSmart model X-100 near- infrared spectrometer
- Where
- Lithuania
- Volunteers
- 150 people
- Sponsor
- Vilnius University
Body Composition
Growth and Body Composition in Preterm Infants
Growth is traditionally used as a prognostic measure after admission to a neonatal intensive care unit (NICU). Quality of neonatal intensive care is one of the factors determining the health and quality of life for those that…
- Trial name
- Crescer (NCT00875251)
- Testing
- body composition
- Where
- 2 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Oswaldo Cruz Foundation
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