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Apnea of Prematurity clinical trials

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NCT ID: NCT02860325 Completed - Clinical trials for Respiratory Distress Syndrome, Newborn

NIV-NAVA Versus Nasal Continuous Positive Airway Pressure (nCPAP) or Non Synchronized NIPPV

Bio-NAVA
Start date: August 1, 2016
Phase: N/A
Study type: Interventional

Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS) and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient discomfort, favouring "fighting" the machine, and increases the risk of air trapping and lung overdistension even in patients with non-invasive ventilation (NIV). Recently, a new modality of synchronization has been available for pediatric and neonatal use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic electrical activity (Edi) as a signal to start the rise in pressure of the ventilator, and to adjust the tidal volume and the inspiratory time (cycling off) to the patient needs, breath by breath. The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities (nCPAP/nIPPV), in infants born < 32 weeks GA with respiratory distress syndrome or requiring prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum cytokines concentration, reduces the need for oxygen and respiratory support, and if it increases the probabilities of survival without bronchopulmonary dysplasia (BPD).

NCT ID: NCT02346864 Completed - Clinical trials for Apnea of Prematurity

Effect of Three-Stair-Position on Improvement of Apnea of Prematurity

Start date: December 2013
Phase: N/A
Study type: Interventional

The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.

NCT ID: NCT02293824 Completed - Caffeine Clinical Trials

Effect of Feedings on Caffeine in Premature Infants

Start date: December 2014
Phase: N/A
Study type: Observational

Almost all infants born <29 weeks gestational age develop apnea of prematurity and are treated with caffeine. Type of diet and disease states may be significant contributors of variability in caffeine metabolism and pharmacokinetics (PK) in this population. This prospective, observational, open-label, opportunistic PK study will compare the population PK of caffeine between infants fed formula and infants fed exclusively breast milk; compare the activities of caffeine metabolizing enzymes between infants fed formula and infants fed exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on caffeine PK and metabolism in premature infants.

NCT ID: NCT01643057 Completed - Clinical trials for Apnea of Prematurity

Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health

Start date: July 2012
Phase: N/A
Study type: Observational

The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants.

NCT ID: NCT01408173 Completed - Clinical trials for Apnea of Prematurity

Clinical Study of Caffeine for Apnea of Prematurity

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.

NCT ID: NCT01066728 Completed - Clinical trials for Apnea of Prematurity

CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

Start date: August 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing more regular with less apneic time than that observed with administration of theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%) will reduce apnea more effectively and will have fewer adverse side effects than theophylline.

NCT ID: NCT01020357 Completed - Clinical trials for Apnea of Prematurity

Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study

CAP-S
Start date: November 2009
Phase: Phase 3
Study type: Interventional

Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain. The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.

NCT ID: NCT00809055 Completed - Brain Injury Clinical Trials

MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine

Start date: November 2008
Phase: Phase 4
Study type: Interventional

Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.

NCT ID: NCT00296231 Completed - Clinical trials for Respiratory Insufficiency

Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

Start date: February 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.

NCT ID: NCT00182312 Completed - Clinical trials for Apnea of Prematurity

Caffeine for Apnea of Prematurity (CAP)

Start date: October 1999
Phase: Phase 3
Study type: Interventional

At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity. Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.