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Infant, Premature, Diseases clinical trials

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NCT ID: NCT01124331 Completed - Clinical trials for Bronchopulmonary Dysplasia

Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

NeOProM
Start date: March 2005
Phase: N/A
Study type: Interventional

The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

NCT ID: NCT01088945 Completed - Clinical trials for Infant, Premature, Diseases

Safe Passages: Ensuring Quality Transitions From NICU (Neonatal Intensive Care Unit) to Ambulatory Care

Start date: March 2010
Phase: Phase 3
Study type: Interventional

Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers and often require significant monitoring and coordination of care in the ambulatory setting. The specific aims of this project are to determine the effectiveness of a redesigned discharge process that includes a Health Coach and an expanded discharge binder to improve health outcomes in the post discharge follow-up period as compared with usual care. The outcomes to be evaluated include the occurrence of adverse events in the post-discharge period, quality of follow up care, and caregiver satisfaction with the process.

NCT ID: NCT01039285 Completed - Clinical trials for Bronchopulmonary Dysplasia

Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

CURDYS
Start date: December 2009
Phase: Phase 4
Study type: Interventional

Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.

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: NCT00571636 Completed - Pain Clinical Trials

Continuous Infusion of Fentanyl in Preterm on MV

Start date: December 2007
Phase: Phase 3
Study type: Interventional

The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV: - Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl; - Group B) continuous infusion of placebo + open label boluses of Fentanyl.

NCT ID: NCT00458068 Completed - Iron Deficiency Clinical Trials

Early Versus Late Enteral Iron in Infants Less Than 1301 Grams

Start date: June 1996
Phase: N/A
Study type: Interventional

Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency. Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended. Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.

NCT ID: NCT00457990 Completed - Iron Deficiency Clinical Trials

Neurodevelopment After Early Iron Supplementation

Start date: April 2002
Phase: N/A
Study type: Interventional

Background: Iron deficiency in early childhood may impair neurodevelopment. Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants. Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.

NCT ID: NCT00419588 Completed - Asthma Clinical Trials

Growth of Airways and Lung Tissues in Premature and Healthy Infants

Start date: September 2006
Phase:
Study type: Observational

The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.

NCT ID: NCT00182390 Completed - Clinical trials for Anemia of Prematurity

Premature Infants in Need of Transfusion (PINT)

Start date: February 2001
Phase: Phase 3
Study type: Interventional

Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly). Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold. Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.

NCT ID: NCT00167388 Completed - Clinical trials for Anemia of Prematurity

The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

Start date: September 2005
Phase: Phase 1
Study type: Interventional

The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood transfusion.