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Very Low Birth Weight Infants clinical trials

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NCT ID: NCT03876704 Recruiting - Sepsis Clinical Trials

Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

Start date: January 29, 2019
Phase: Phase 3
Study type: Interventional

Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. Deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. Preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. Intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. However, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. The purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.

NCT ID: NCT03858816 Withdrawn - Clinical trials for Very Low Birth Weight Infants

Efficacy of Multiple Strain Probiotics Reduces the Neurobehavioral Disorder in Premature Very Low Birth Weight Infants

Start date: June 14, 2018
Phase: N/A
Study type: Interventional

The management protocols, clinical practices, equipment, infrastructure, and key personnel in NICU are unchanged during the study period. The data collected by each center are transmitted to the office of the principal investigator (Dr Lin) at China Medical University Hospital. Primary outcome is death or attention deficit and hyperactivity disorder (ADHD) and ASD.

NCT ID: NCT02741934 Completed - Clinical trials for Very Low Birth Weight Infants

Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm

Start date: October 2015
Phase: N/A
Study type: Observational

This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.

NCT ID: NCT02731092 Recruiting - Clinical trials for Very Low Birth Weight Infants

Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants

Start date: April 2016
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants

NCT ID: NCT02415530 Completed - Clinical trials for Very Low Birth Weight Infants

Early Family Based Intervention in Preterm Infants

Start date: March 2015
Phase: N/A
Study type: Interventional

This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.

NCT ID: NCT02383264 Completed - Clinical trials for Necrotizing Enterocolitis

Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.

NIRS-SO
Start date: February 2013
Phase: N/A
Study type: Observational

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the establishment of an adequate early enteral nutrition is frequently hampered. Early identification of preterm infants at high risk for gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding. Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been reported. To date, however, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been yet established. This observational prospective study aims: - to assess abdominal rSO2 patterns in response to the first bolus feed; - to evaluate possible correlations with subsequent development of gastrointestinal complications.

NCT ID: NCT02337088 Terminated - Clinical trials for Intraventricular Hemorrhage

Delayed Cord Clamping in Very Low Birth Weight Infants

DCC
Start date: April 16, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.

NCT ID: NCT01531192 Completed - Clinical trials for Very Low Birth Weight Infants

Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Start date: June 2012
Phase: Phase 4
Study type: Interventional

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. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.

NCT ID: NCT01531179 Completed - Clinical trials for Necrotizing Enterocolitis

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Start date: February 2012
Phase: Phase 3
Study type: Interventional

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. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

NCT ID: NCT01443091 Completed - Clinical trials for Very Low Birth Weight Infants

Oropharyngeal Colostrum for Immune Stimulation in Very Low Birth Weight Infants

Start date: January 2011
Phase: N/A
Study type: Interventional

Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.