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Bronchopulmonary Dysplasia clinical trials

View clinical trials related to Bronchopulmonary Dysplasia.

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NCT ID: NCT04865302 Recruiting - Preterm Birth Clinical Trials

Cerebral Oxygenation in Preterm Neonates With Respiratory Support During Skin-to-skin Care on the First Day After Birth

Kangaroo
Start date: October 1, 2021
Phase:
Study type: Observational

This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth.

NCT ID: NCT04825197 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial

LateRecSurf
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

This is an unblinded monocentric pilot superiority trial that will be conducted in a IIIlevel NICU at Fondazione Policlinico Agostino Gemelli - IRCCS. The aim of the study is to test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation. Extremely low gestational age newborn infants (GA < 28 weeks) still requiring invasive mechanical ventilation at a postnatal age between 7 and 10 days will be eligible for the study. The study population will be randomly assigned to experimental protocol or to standard care. Treatment group will receive up to 4 doses (100 mg Kg) of Poractant alfa every 12 hours; each dose will be preceded by a recruitment manoeuvre in HFOV. Primary endpoint will be the first successful extubation defined as extubation not followed by a reintubation for at least 7 days. Several secondary endpoints will be collected, including respiratory status at one year of age.

NCT ID: NCT04821453 Recruiting - Clinical trials for Mechanical Ventilation

NAVA vs. CMV Crossover in Severe BPD

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).

NCT ID: NCT04785859 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Multiparametric Bronchopulmonary Prediction

PARADYS
Start date: December 1, 2020
Phase:
Study type: Observational

INTRODUCTION: Current Neonatology has failed to reduce the incidence of moderate-severe bronchopulmonary dysplasia (BPD). Although multiple models for predicting the risk of dysplasia in preterm infants have been studied, none have been implemented in clinical practice. OBJECTIVE: To calculate a mathematical model to predict moderate-severe bronchopulmonary dysplasia in newborns before 30 weeks of gestation based on pre and postnatal clinical variables, lung ultrasound images and detection of biomarkers in nasopharyngeal aspirate. METHODOLOGY: Multicenter case-control study, in which 10 Spanish neonatal intensive care units (NICU) will participate. All participants will undergo a lung ultrasound in the first 24 hours, on the third day of life, at one week and two weeks of life, a nasopharyngeal aspirate at one week of life, and cardiac ultrasound at one week and two weeks of life. It is expected to include 240 patients in 29 months of study among all participating units: 200 for the calculation of the model, and 40 more for its subsequent validation. These will be divided between those with a diagnosis of moderate-severe BPD and those without, and the values of each of the variables described in the methodology section will be compared between the two groups. Those with a significant difference will be entered into a logistic regression model to calculate those that best predict the final diagnosis. With the results of the calculated model, a mobile application will be created with a risk of moderate-severe BPD calculator in this population, for its worldwide distribution.

NCT ID: NCT04499196 Recruiting - Clinical trials for Pulmonary Hypertension

Glucocorticoids and Pulmonary Hypertension

Start date: July 29, 2020
Phase:
Study type: Observational

Pediatric idiopathic pulmonary hypertension has significant morbidity and mortality. An ever expanding body of knowledge indicates the important contribution of inflammation to pathogenesis and successful treatment with glucocorticoids. Over the last several years the investigators have utilized steroids in patients with severe pulmonary hypertension as part of a treatment regimen. These basic science studies possibly identifies a biochemical etiology for the development of disease and may also be impacted by the administration of steroids. Additionally, there is a commercially available assay which tests for all of the above molecules.

NCT ID: NCT04447989 Recruiting - Clinical trials for Bronchopulmonary Dysplasia of Newborn

Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

SILDI-SAFE
Start date: May 27, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary dysplasia (BPD).

NCT ID: NCT04440670 Recruiting - BPD Clinical Trials

Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates

Start date: June 20, 2020
Phase: Phase 3
Study type: Interventional

This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death. The results of this trial will provide valuable clinical evidence for recommendations on the management of BPD in extremely preterm infants. In this prospective, randomized controlled double-blind multi-center clinical trial, 140 extremely preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (targeted dose of 5×107cells/kg but no less than 1×107cells/kg) or placebo ( normal saline) within 24 hours after birth in a 1:1 ratio using a central randomization system. The primary outcome is survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include mortality rate, BPD severity, other common preterm complication rate, respiratory support duration, the length and cost of hospitalization and long term outcomes after two years follow up post infusion.

NCT ID: NCT04393337 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants

ELEGANT
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

Endotracheal intubation is a life-saving intervention that few infants need after birth. Although an endotracheal tube is the most reliable way of providing positive-pressure breath, the critical factor that determines the maximal efficacy of positive-pressure ventilation is the optimal placement of the endotracheal tube tip. There are various methods available to determine the initial depth of endotracheal tube (ETT) that are based on the infant's birth weight, gestational age, anthropometric measurements, and others include vocal cord guide and suprasternal palpation methods. The Neonatal Resuscitation Program (NRP) textbook, in its 7th edition of the textbook, recommends a gestational age chart and nasal-tragus length method for estimating endotracheal tube insertion depth during cardiopulmonary resuscitation of the neonate. The evidence to support these two methods is, however, limited. Hence, we designed this study to determine the accuracy of two methods, gestational age chart and nasal-tragus length method, recommended by the Neonatal Resuscitation Program.

NCT ID: NCT04278404 Recruiting - Hypertension Clinical Trials

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

POPS or POP02
Start date: March 5, 2020
Phase:
Study type: Observational

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT ID: NCT04270045 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

Start date: February 6, 2020
Phase:
Study type: Observational

The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)