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Bronchopulmonary Dysplasia clinical trials

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NCT ID: NCT02921308 Completed - Clinical trials for Bronchopulmonary Dysplasia

Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes

PICTURE
Start date: January 5, 2018
Phase:
Study type: Observational

Health Issue: Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common complication of being born premature. Damage to the still developing lung stops the normal formation of the alveoli. Young adults with a history of BPD have lower lung function, early heart disease, and increased risk of death, compared to those without BPD. Recently, it has been reported that they may also develop a type of lung disease typically seen in older adults with a longstanding history of smoking. The severity of lung disease is usually measured using pulmonary function tests (PFT), but these tests may be normal, even in the presence of important changes in the fine structure of the lung. Such structural changes may be early markers of future lung disease and can be detected using lung magnetic resonance imaging (MRI). Unlike other ways of imaging the lungs, MRI does not expose people to harmful X-rays. To date, no studies have been done to examine the fine structure of the lung of school-aged children who had a history of BPD, to determine whether there are signs of lung disease that might not otherwise be obvious. This is important because once armed with this information, preventive measures can be taken to avoid worsening of lung disease. Objective: 1) In 7-9 year-old children born extremely premature, lung MRI will be compared between those with and without BPD. The Investigators expect to observe more severe structural lung abnormalities in children with BPD, compared to those without BPD; 2) The Investigators will test to see if children with more severe MRI abnormalities also have worse lung function, and/or more symptoms of breathing problems. The Investigators expect to observe more PFT abnormalities in children with BPD than in those without and that these will match up with lung fine structure abnormalities identified on MRI. How will work be undertaken? Children 7-9 years old who were born extremely prematurely will be recruited to participate in this study. Participants will be identified from Neonatal Follow-up clinics they attended. The Investigators will enroll 20 children with BPD and 20 without BPD. Participants will have lung MR images taken, during which they need to lie still for a few minutes. PFT will also be performed, during which they will blow into a machine. Parents will be asked to complete questionnaires about breathing problems, their living conditions (environment) and any doctor visits or hospital stays. Medical charts will be reviewed for information about their birth. Unique/Innovative Aspects: This will be the first study using MRI as an innovative way to visualize and measure fine structure of the lung in children born prematurely with and without BPD. These findings may be early markers of lung disease, which would identify children who have, or are at risk of developing lung disease later in life, for whom the Investigators may be able to offer treatments now and/or prevent worsening of lung disease.

NCT ID: NCT02907593 Completed - Clinical trials for Bronchopulmonary Dysplasia (BPD)

Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial

SASSIE
Start date: September 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.

NCT ID: NCT02853253 Withdrawn - Preterm Neonates Clinical Trials

Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide

SMOF
Start date: January 2017
Phase: Phase 4
Study type: Interventional

SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.

NCT ID: NCT02820818 Completed - Premature Birth Clinical Trials

Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

Start date: June 2016
Phase:
Study type: Observational

Preterm birth alters the normal sequence of lung development with lasting respiratory consequences. It is still unclear whether observed respiratory morbidities in preterm born individuals reflect sequelae from a non-progressive lung disease that occurred early in life or result from ongoing active disease that, if left undiagnosed and untreated, could increase the risk of a COPD-like phenotype. We propose to examine micro-structural abnormalities of the lung using innovative non-invasive imaging technologies in relation to pulmonary function and markers of inflammation and oxidative stress in young adults born preterm.

NCT ID: NCT02819050 Completed - Clinical trials for BronchoPulmonary Dysplasia

Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants

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

Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.

NCT ID: NCT02788110 Completed - Clinical trials for Bronchopulmonary Dysplasia

Work of Breathing During Non-invasive Ventilation in Premature Neonates

Start date: August 2016
Phase: N/A
Study type: Interventional

Background: Non-invasive forms of respiratory support have been developed to manage respiratory distress and failure in premature newborns without exposing them to the risks associated with invasive mechanical ventilation. It has been difficult to synchronize non-invasive ventilation due to the large air leaks, high respiratory rates, and small tidal volumes inherent to this interface and population. Neurally adjusted ventilatory assist (NAVA) is a novel mode of ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to support these efforts as needed. Few studies have examined the use of NAVA with non-invasive ventilation (NIV) in preterm neonates. A group at Arkansas Children's Hospital recently completed a study, looking at work of breathing in an animal model comparing NIV NAVA with the unsynchronized nasal intermittent positive pressure (NIPPV) mode currently used at this hospital. They were able to show that work of breathing was lower with NAVA in this model. This study will take what was shown in the animal model and translate this to the bedside. Using respiratory inductance plethysmography to measure thoracoabdominal asynchrony, this study will compare work of breathing during NIPPV versus NIV NAVA in preterm neonates with respiratory insufficiency. Hypothesis: Work of breathing as estimated by the phase angle (θ) using respiratory inductance plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized NIPPV in premature neonates with respiratory insufficiency. Methods: Fifteen premature neonates of between 1-2 kilograms' current weight, with gestational age at birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the study after consent is obtained. The infants will be ventilated using NIV NAVA and NIPPV applied in random order for 15 minutes each while using respiratory inductance plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing. Significance: This study will identify whether or not NIV NAVA has advantages over NIPPV for improving work of breathing in premature neonates.

NCT ID: NCT02784821 Completed - Clinical trials for Bronchopulmonary Dysplasia

Antibiotic "Dysbiosis" in Preterm Infants

Start date: January 16, 2017
Phase: Phase 2
Study type: Interventional

Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and mortality. The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities. It is possible that the effect of this widespread antibiotic use outweighs the potential benefits. This study will randomize preterm infants born at less than 33 weeks gestation to either pre-emptive antibiotics or no-pre-emptive antibiotics. The purpose of this research is to evaluate the risks and benefits of current practice to determine optimal levels of antibiotic use that protects the babies from infection with minimal effect on the microbiome and subsequent adverse outcomes related to overuse of antibiotics.

NCT ID: NCT02766673 Completed - Clinical trials for Severe Bronchopulmonary Dysplasia

Aerosolized Albuterol Use in Severe BPD

Start date: August 2016
Phase: N/A
Study type: Interventional

Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved for this population (under 2 years) there is no standard recommended dose. Aerosolized Albuterol is one of the most widely used therapies that are utilized for infants with chronic lung disease. The common practice in the N/IICU is weight base dosing of all medications. This contradicts the aerosol science recommendations, which advise not to titrate doses by weight as the patient naturally self-regulates their dose according to the change in minute ventilation with age. In addition, the wide use of aerosolized Albuterol in the infant with Bronchopulmonary Dysplasia (BPD) has little current evidence of efficacy in this disease. Understanding the appropriate dose for effective treatment as well as the indication for use in the BPD population would provide the clinician with useful guidelines. The investigators propose to analyze the safety and efficacy of aerosolized albuterol in infants with BPD comparing the recommended dose per aerosolization literature with the common dosing practices at The Children's Hospital of Philadelphia (CHOP) as well as placebo.

NCT ID: NCT02729844 Completed - Clinical trials for Pulmonary Hypertension

Neolifes Heart - Pulmonary Hypertension in Preterm Children

Start date: June 1, 2016
Phase:
Study type: Observational [Patient Registry]

NeoLifeS is a cohort follow up study that prospectively collects data of regular care of children born preterm in the University Medical Center Groningen (UMCG) and aims to improve the quality of care for these children. NeoLifeS-Heart is a sub-study that focuses on the problem that a high proportion of preterm infants develop cardiovascular disorders. Related to the immaturity of their lungs, preterm infants are at risk to develop the condition Bronchopulmonary dysplasia (BPD). Also, the vasculature of the lungs is often not fully developed, making them more vulnerable for the development of Pulmonary Hypertension (PH), a high blood pressure in the lungs. 15-20% of the infants with extremely low birth weight are believed to develop PH, this proportion has been suggested to raise to 50% in infants with severe BPD. The presence of PH significantly worsens the prognosis and survival of these children. The condition PH is insufficiently characterized. Knowledge of incidence, prevalence, risk factors for the development of PH and survival, will be the first step in improving detection strategies, possible treatment options and thereby prognosis and survival of these children. Objective: To determine the incidence and prevalence of PH in preterm infants. In addition we aim to identify risk factors for the development of PH and determine the survival and prognosis of these preterm infants. Study design: A prospective cohort study. Study population: All preterm infants, admitted at the neonatology UMCG, born <30 weeks and/or birth weight < 1000 gram, who participate in NeoLifeS Primary parameters: The occurrence of PH (Incidence and Prevalence). Secondary parameters: - Maternal and neonatal patient characteristics that are potential risk factors for the development of PH, - Morbidity-score (quality of life and hospital admissions) and mortality.

NCT ID: NCT02723513 Completed - Preterm Birth Clinical Trials

Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term to characterize and probe the relationship between lung structure and function using imaging.