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Premature Birth clinical trials

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NCT ID: NCT02269774 Terminated - Atrial Fibrillation Clinical Trials

Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

Start date: September 2014
Phase: N/A
Study type: Interventional

There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy. We have previously shown that simulated OSA triggers premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of atrial fibrillation are initiated by PABs. However, the origin of PABs induced by intra-thoracic pressure swings is unknown. This study investigates the origin of premature atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea in patients with atrial fibrillation.

NCT ID: NCT02114112 Terminated - Premature Birth Clinical Trials

E-23596 - Use of NCPAP Cycling to Wean Preterm Infants

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

Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP) cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation to nasal prongs. Methods: A total of 40 infants with a gestational age (GA) of 25-28 weeks ventilated for respiratory distress syndrome (RDS) and extubated to NCPAP are eligible for the study. They will be randomized to NCPAP cycling {Group A; cycling between NCPAP of 4 cm and 1litre per minute of nasal prongs} or to continuous CPAP at 4 cm of water (Group B). Primary outcome is the number of babies who came off NCPAP at the end of 72 hours of the intervention and remained off NCPAP for the next 72 hours. The duration of NCPAP, Bronchopulmonary dysplasia (BPD) at 36 weeks post menstrual age and Retinopathy of Prematurity (ROP) stage ≥3 will be the secondary outcomes.

NCT ID: NCT02042235 Terminated - Preterm Birth Clinical Trials

Very Preterm Children With Language Delay and Parent Intervention

EPILANG
Start date: January 2014
Phase: N/A
Study type: Interventional

In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. However, for term-born children, parent-implemented language interventions conducted during the third year of life have already shown a positive short-term effect on language skills. In these interventions, a skilled interventionist, generally a speech therapist, teaches parents how to use specific language strategies with their child. The investigators' hypothesis is that such parent-implemented interventions would be particularly appropriate at short and medium term for the improvement of linguistic performances in very preterm children, a population with a high prevalence of early language delay. Currently, there is an opportunity to partly nest an intervention trial in a national prospective population-based cohort of very preterm children, the EPIPAGE (Etude EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies born alive in France in 2011. This situation provides considerable methodological advantages.

NCT ID: NCT02040909 Terminated - Clinical trials for Anesthesia Intubation Complication

Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation

NEOPROP2
Start date: July 2014
Phase: Phase 1
Study type: Interventional

Newborns admitted to an intensive care unit often require artificial ventilation. For that purpose an endotracheal tube needs to be placed into the trachea, a procedure named endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop moving and to relax in order to enable the success of the procedure. For this sedation an anesthetic agent named propofol is often used. The used dose of propofol has not been properly studied and as a consequence patients are under- or over -sedated and propofol leads to side effects such as hypotension. The current study aims to find the most appropriate dose of propofol for newborns of different gestational ages and of different post-natal ages. We will use propofol in different doses and after each 5 included patients per age group we will analyze whether the dose needs to be increased or decreased. The effect of the propofol will be extensively monitored and we will study the level of sedation, the quality of intubation, the stability of the patient en the occurrence of side effects. At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.

NCT ID: NCT02021539 Terminated - Clinical trials for Obstetric Labor, Premature

The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery

ElastoMAP
Start date: February 2014
Phase: N/A
Study type: Observational

The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

NCT ID: NCT01977079 Terminated - Pregnancy Clinical Trials

Procalcitonin and Threatened Premature Delivery

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

Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP. The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .

NCT ID: NCT01954082 Terminated - Clinical trials for Retinopathy of Prematurity (ROP)

Inositol to Reduce Retinopathy of Prematurity

INS-3
Start date: April 17, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.

NCT ID: NCT01917006 Terminated - Clinical trials for Premature Ejaculation

A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

Start date: August 7, 2013
Phase: Phase 2
Study type: Interventional

This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.

NCT ID: NCT01911182 Terminated - Clinical trials for Apnea of Prematurity

Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea

Start date: October 2011
Phase: Phase 2/Phase 3
Study type: Interventional

In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine is currently a worldwide therapy to reduce the number and severity of these apneas. This practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21 months of age. However, caffeine is not 100% effective, and may have little effect on hypoxemia and bradycardia. Infants with intractable apneas unresponsive to caffeine treatment may require endotracheal intubation and mechanical ventilation. This procedure is invasive and has been associated with complications and increased risk for chronic lung disease and adverse neurodevelopmental outcome. Therefore, an alternative treatment modality would be preferable if it would prevent the infants from requiring endotracheal intubation. The investigators have been testing the overall hypothesis that small concentrations of inhaled CO2 (~1%) are effective in treating apnea of prematurity. The investigators have completed three studies in preterm infants showing that inhalation of low concentration of CO2, in infants not on caffeine, regularize breathing and decrease apneas significantly. The effects of inhalation of CO2 in infants already on caffeine, are unknown. The hypothesis to be tested is that inhalation of low concentration CO2 (1%) will significantly reduce apnea in infants treated with caffeine. The investigators have three specific aims in this proposal. 1) the investigators want to know if the apnea rate (number of apneas of ≥5 seconds/hour) is decreased with CO2 inhalation in preterm infants already on caffeine for the treatment of apnea of prematurity; 2) the investigators want to know whether inhalation of CO2 can make breathing more regular with less apneic time and whether it decreases prolonged apneas (>20 seconds) in infants already on caffeine for the treatment of apnea of prematurity; 3) the investigators want to assess the effect of inhalation of low concentration of CO2 on the regional oxygen saturation of the brain measured by near-infrared spectroscopy (NIRS) during apneas. This is to see whether CO2, by protecting cerebral blood flow, minimizes the decrease in cerebral oxygenation during apneas. This study entails a new and possibly more physiological method of treating apneas of prematurity that can be added to the present treatment of caffeine. These two treatments together, could minimize the number and severity of apneas and possibly decrease the need for mechanical ventilation in preterm infants.

NCT ID: NCT01840228 Terminated - Premature Birth Clinical Trials

Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor

PAL
Start date: May 2013
Phase: N/A
Study type: Interventional

Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.