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Birth Weight clinical trials

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NCT ID: NCT00601081 Completed - Clinical trials for Infant, Very Low Birth Weight

Human Milk Fortifier and Cytokine Profile

Start date: November 2007
Phase: N/A
Study type: Observational

This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

NCT ID: NCT00599053 Terminated - Clinical trials for Respiratory Tract Infections

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Start date: May 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for BPD. We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection

NCT ID: NCT00593801 Completed - Anemia Clinical Trials

Erythropoietin Treatment in Extremely Low Birth Weight Infants

EPO
Start date: May 1998
Phase: N/A
Study type: Interventional

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. The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Study population: 219 patient randomized into 3 groups

NCT ID: NCT00593684 Completed - Prematurity Clinical Trials

The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants

Start date: April 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.

NCT ID: NCT00582374 Withdrawn - Preterm Birth Clinical Trials

Periodontal Disease and Preterm Birth

Start date: March 2005
Phase: N/A
Study type: Observational

To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

NCT ID: NCT00579943 Completed - Clinical trials for Infant, Premature, Diseases

Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants

Start date: May 2001
Phase: N/A
Study type: Observational

Advances in newborn intensive care have lead to dramatic improvements in survival for the most premature infants—often weighing 1 pound at birth. Unfortunately, cerebral palsy, mental retardation, and developmental delay affect more than 10,000 of these premature infants in the U.S. annually. In his studies, Dr. Jeffrey R. Kaiser is trying to understand why these premature infants are at such high risk of brain injury, and to learn ways to prevent injury. Experts believe that disturbances of brain blood flow regulation are important in causing these injuries. Using a novel continuous monitoring system, Dr. Kaiser is able to determine an infant's capacity for normal brain blood flow regulation. Contrary to previous thinking, he has shown that many of these babies in fact due have normal regulation of their brain blood flow. He has observed that brain blood flow may be disturbed during suctioning of the breathing tube. Further, he has also shown that infants with high carbon dioxide, those not breathing well, have impaired regulation of their brain blood flow. Thus, even stable infants are prone to disturbed brain regulation during routine intensive care, which may lead to bleeding in the brain and long-term neurologic problems. Dr. Kaiser will study up to 200 infants to determine 1) the developmental pattern of normal regulation of cerebral blood flow; 2) in those with impaired regulation, determine when it develops during the first week of life; and 3) determine the relationship between impaired brain blood flow regulation and brain injury. Results from this study will help us recognize when premature infants are most vulnerable to developing brain injury, allowing prevention and intervention strategies to be initiated in a timely fashion.

NCT ID: NCT00558454 Completed - Anemia Clinical Trials

Iron Supplementation of Marginally Low Birth Weight Infants

JOHN
Start date: March 2004
Phase: Phase 4
Study type: Interventional

Iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns have low birth weight (< 2500 g). Due to small iron stores at birth and rapid postnatal growth, they have increased risk of iron deficiency and it is therefore important to prevent iron deficiency in this population. However, excessive iron supplementation can have adverse effects in infants such as growth impairment. In a randomized, controlled trial, we are investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive development and growth in low birth weight infants.

NCT ID: NCT00554866 Completed - Clinical trials for Infant, Very Low Birth Weight

L-arginine Concentrations and CPS Polymorphisms in VLBW Infants

Start date: July 2007
Phase: N/A
Study type: Interventional

Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been correlated with low plasma concentrations of L-arginine in neonates (> 35 weeks of gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW infants. However there is no data about the correlation between the plasma arginine concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of NEC.

NCT ID: NCT00540033 Terminated - Clinical trials for Enterocolitis, Necrotizing

Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants

Start date: February 2005
Phase: Phase 2
Study type: Interventional

We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).

NCT ID: NCT00531492 Completed - Low Birth Weight Clinical Trials

Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries

EtudeTK
Start date: August 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country. For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.