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Infant, Newborn clinical trials

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NCT ID: NCT01281566 Terminated - Infant, Premature Clinical Trials

A Study of Cisapride in Premature Infants With Feeding Problems

Start date: March 2003
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.

NCT ID: NCT01192776 Terminated - Infant, Newborn Clinical Trials

Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)

Start date: September 2010
Phase: N/A
Study type: Interventional

The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.

NCT ID: NCT00016523 Terminated - Sepsis Clinical Trials

Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

Preemie iNO
Start date: January 2001
Phase: Phase 3
Study type: Interventional

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.

NCT ID: NCT00005777 Terminated - Clinical trials for Bronchopulmonary Dysplasia

Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)

SAVE
Start date: February 1998
Phase: Phase 3
Study type: Interventional

This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.

NCT ID: NCT00005776 Terminated - Clinical trials for Respiratory Insufficiency

Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

NINOS
Start date: October 1995
Phase: Phase 3
Study type: Interventional

Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.

NCT ID: NCT00005774 Terminated - Clinical trials for Respiratory Insufficiency

Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

Surfactant 2
Start date: May 2000
Phase: Phase 3
Study type: Interventional

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

NCT ID: NCT00005773 Terminated - Clinical trials for Respiratory Insufficiency

Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

Early iNO
Start date: August 1998
Phase: Phase 3
Study type: Interventional

This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at >34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) >15 and <25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.