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Bronchopulmonary Dysplasia clinical trials

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NCT ID: NCT06342752 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia

INFANCY
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates. Despite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways. Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored. Thirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated. The threefold aim of this study is as follows: I. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress. II. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome. III. The detection of potential alterations in airway mucin expression in BPD patients. Through this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD. In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included.

NCT ID: NCT06279741 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants

EVENEW
Start date: December 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution). Infants will be followed up to 2 years of corrected age (end of study).

NCT ID: NCT06270199 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

Start date: January 11, 2024
Phase: Phase 2
Study type: Interventional

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.

NCT ID: NCT06110481 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Reversibility of Bronchial Obstruction in Children Born Preterm

Start date: April 1, 2021
Phase:
Study type: Observational

This observational study aims to compare responses to different, commonly used inhaled bronchodilators in children born preterm with bronchial obstruction at spirometry. All children were diagnosed with Chronic Lung Disease of Immaturity (CLDI). The main questions are: - Is any inhaled bronchodilator or their combination generally superior in children with CLDI when assessing the reversibility of bronchial obstruction? - Is there an individual difference in the effect of betamimetic, anticholinergic or their combination between children with CLDI? Participants will: - Come to our clinic in a stable state without acute infection and they will be randomly assigned to the first inhaled bronchodilator. - They will then perform a spirometry test before and after the inhalation of the drug. - This visit will repeat 3 times, each with a different bronchodilator (beta2agonist, anticholinergic and their combination).

NCT ID: NCT06082414 Completed - Clinical trials for Bronchopulmonary Dysplasia

Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants

Start date: January 30, 2019
Phase:
Study type: Observational

to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

NCT ID: NCT06065215 Recruiting - Lung Function Clinical Trials

Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)

EMBLEM
Start date: March 30, 2024
Phase:
Study type: Observational

Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. It is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. New magnetic resonance imaging (MRI) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. The ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new BPD therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.

NCT ID: NCT06045130 Not yet recruiting - Sepsis Clinical Trials

PUFAs in Preterm Infants

PIPI
Start date: September 21, 2023
Phase:
Study type: Observational

The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.

NCT ID: NCT06026163 Not yet recruiting - Prematurity Clinical Trials

Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

CAT/LPT
Start date: October 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

NCT ID: NCT06000761 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Start date: November 23, 2023
Phase: N/A
Study type: Interventional

Premature infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 168 VLBW infants for 4 weeks following birth.

NCT ID: NCT05987800 Recruiting - Premature Birth Clinical Trials

Non-invasive Ventilation in Preterm Infants

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.