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75 active trials for Bronchopulmonary Dysplasia

Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

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

Start: February 2020

Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.

Start: May 2019

Inhaled Treatment for Bronchopulmonary Dysplasia

The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia

Start: October 2021

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

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.

Start: August 2021

Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD

Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.

Start: May 2021

Safety of Sildenafil in Premature Infants

Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding Source - FDA OOPD.

Start: April 2018

A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants

The purpose of this study is to determine if an investigational drug can reduce the burden of chronic lung disease in extremely premature babies through 12 months corrected age (CA), as compared to extremely premature babies receiving standard neonatal care alone.

Start: May 2019

Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.

We aim to evaluate in this pilot study whether standardized prone positioning compared to usual positioning improves moderate to severe BPD rates as assessed at 36 weeks post conceptional age in very low birth weight preterm infants with bronchopulmonary dysplasia.

Start: June 2021

BPD Saturation TARgeting

Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.

Start: June 2018

Preservation of Blood in Extremely Preterm Infants

Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine. Excessive blood sampling volumes and the resulting loss of fetal blood components are related to neonatal morbidity. This randomised trial aims to provide evidence that preservation of blood using micro-methods results in decreased morbidity and increased quality of life in extremely preterm infants.

Start: March 2020

Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia

Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants. To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD. To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.

Start: July 2019

Inhaled Tobramycin in BPD

This study is an open-label, phase 1, inter-patient dose escalation feasibility trial seeking establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different doses of inhaled tobramycin administered to very preterm infants with BPD who are receiving invasive mechanical ventilation and have a pathogenic Gram-negative organism detected by tracheal aspirate culture.

Start: July 2021

Pulmonary Function Using Non-invasive Forced Oscillometry

The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and response to treatments given to newborn infants with lung diseases using a non-invasive airway oscillometry system.

Start: December 2017

Analysis of BPD in Premature Infants With Typical Imaging Changes

Bronchopulmonary dysplasia (BPD) is a common respiratory disease in premature infants, the incidence of which is increasing in recent years. It seriously affects the survival rate and quality of life of premature infants. At present, the diagnosis of BPD mainly adopts the 2001 NICHD standard, which does not account for the radiographic information. However, some recent studies revealed that the BPD infants with fibrotic and cystic radiographic changes required longer-term invasive ventilation, longer-term parenteral nutrition, more frequent red blood transfusion and a higher risk of home oxygen therapy. The infants with moderate or several BPD were also reported to be more likely to have a radiographic appearance with fibrosis or cysts than those with mild BPD. The radiographic patterns of BPD were stratified into four stages according to the lung pathology. The fibrotic and cystic patterns were defined as the typical changes of BPD, which is commonly present at 10 days or later after birth. However, it is not uncommon to occur earlier. One study reported that 23%?27% of infants with moderate or severe BPD had typical radiograph changes on the first day of life. The exact etiology of early fibrotic and cystic changes is little known, which is likely to be associated with intrauterine inflammation. Chorioamnionitis and intrauterine infection was believed to induce fetal lung inflammation, which could interfere with lung development, resulting in BPD. Therefore, early radiographic fibrotic and cystic appearance may indicate a specific stage of lung inflammation, which originates in the intrauterine infection and subsequently develop BPD. Currently, BPD is diagnosed solely based on oxygen dependence, which does not reflect the etiology and pathogenesis. It can be speculated that BPD may have different subgroups; each subgroup could have unique etiology, clinical and radiographic patterns, and prognosis. The BPD with early fibrotic and cystic radiographic changes is likely to be a particular subgroup, which is likely to be attributable to intrauterine infection. Therefore, this retrospective study aims to depict the clinical profiles and prognosis of BPD infants with early typical radiographic changes, which will be of great potential for early-adopting tailored management and improving the long-term outcome of this group of infants.

Start: January 2020

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ?32 weeks of gestational age (GA).

Start: May 2021

Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care practice. The investigators hypothesize that infants who receive an exclusive human milk (HM)-based diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a shorter length of initial hospital stay compared to infants receiving the standard regimen of an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of the cream caloric supplement will be greater in the subgroup of infants who develop BPD so the relationship will be evaluated between Cream Supplement study group and postmenstrual age (PMA) at discharge and the incidence of BPD. Investigators will also evaluate the post-hospital discharge growth, body composition, and neurodevelopmental outcomes at 18 to 24 months CGA of the infants 500-1250 grams BW who received an exclusive human milk diet including cream supplement or control in the NICU.

Start: June 2015

Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.

Start: October 2018

Fluid Filled Lung Oxygenation Assistance Trial

The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).

Start: June 2017

Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD

Patients will be randomized to begin the study with either NAVA-synchronized or continuous HFNC. Each patient will receive two 15-minute trials at different levels of continuous HFNC and two 15-minute trials at corresponding levels of synchronized HFNC. In synchronized HFNC, using the NIV NAVA mode on the ventilator each subject will receive a constant minimum flow, but with each neurally triggered breath (as measured with an Edi catheter), an additional flow will be given to the patient. This differs from continuous HFNC in which the subject receives a constant flow without variation. Subjects will be observed during the entirety of these trials. Values for the primary and secondary outcomes will be monitored, recorded, and calculated.

Start: February 2020

Phase 1b Study on AT-100 Intervention (rhSP-D) in Preterm Neonates at High Risk for Development of Bronchopulmonary Dysplasia (BPD)

The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham alone.

Start: April 2021