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Bronchopulmonary Dysplasia clinical trials

View clinical trials related to Bronchopulmonary Dysplasia.

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NCT ID: NCT05071638 Not yet recruiting - BPD Clinical Trials

Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates

Start date: October 1, 2021
Phase: Phase 3
Study type: Interventional

This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD. The results of this trial will provide valuable clinical evidence for recommendations on the treatment of BPD in extremely preterm infants. Informed consent before birth is signed. In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups. The primary outcome is the rate of mortality or ratio of severe BPD at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include other common preterm complication rate and the number of hospitalizations due to pneumonia within 1 year of postmenstrual age.

NCT ID: NCT04862377 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

BuS
Start date: October 1, 2021
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT04696003 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion

AmnionFlush
Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

Objective: Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of all pregnancies and associated with very high neonatal mortality and morbidity. Antibiotics have limited success to prevent bacteremia, chorioamnionitis and fetal inflammation because of reduced placental transport. The repetitive amnioinfusion doesn't work because of immediately fluid lost after the intervention). The continuous amnioinfusion with Amnion Flush Solution through the perinatal port system in patients with classic PPROM prolonged the PPROM-to-delivery interval to 49 days in average by flush out of bacteria and inflammatory components from the amniotic cavity. Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal survival without major morbidities, like severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis. Design: randomized multicenter controlled trial; two-arm parallel design. Control group: 34 PPROM patients between 22/0 (20/0) -26/0 WG treating with antibiotics and corticosteroids in according to DGGG guide-lines. In interventional group (n=34) the standard PPROM therapy will be complemented by "Amnion -Flush" method with the amnioinfusion of artificial amniotic fluid (Amnion Flush Solution, Serumwerk AG, Germany, 2400 ml/d). Subjects: Patients with classic PPROM between 22/0-26/0 WG. Expected outcome:The investigators expect significant reduction of neonatal mortality and morbidity in the "Amnion-Flush" group.

NCT ID: NCT04555889 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia

Start date: October 31, 2020
Phase: N/A
Study type: Interventional

hypothesis : 1. The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. 2. The serum levels of surfactant protein-D in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. 3. The serum concentration of CD-31+ and CD-42b- in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. 4. The right and left cardiac output in 24-32 weekers babies on assist-control volume guarantee mode are more higher in lung recruitment maneuver (LRM) group, than group that did not get LRM 5. The incident Patent Ductus Arteriosus in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. 6. The difference tc-pCO2 - PaCO2 , tcO2 index , and strong ion difference (SID) in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.

NCT ID: NCT04497740 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Follow-up Results of Newborns With Tracheostomy

FRONWT
Start date: August 10, 2020
Phase:
Study type: Observational

The chances of survival in premature babies, especially in babies born under 28 weeks, have increased in recent years, and comorbidities also increase. Bronchopulmonary dysplasia (BPD), one of the premature problems, is one of them. After a while, babies with heavy BPD are discharged with the support of a home-type mechanical ventilator by opening a tracheostomy. Tracheostomy procedure is performed by specialist doctors of otolaryngology under general anesthesia in the operating room conditions in newborns. Complications of this procedure such as bleeding, skin necrosis, decanulation, trachea laceration and infection in the early period can be seen. In the long term, in addition to complications such as formation of tracheal granulation tissue, ulceration, laceration due to the procedure, babies with tracheostomy may develop nutrition and speech problems and neurodevelopmental problems. In the literature, there is no comprehensive clinical follow-up study involving early and late clinical results related to newborns undergoing tracheostomy. In this study, early and late follow-up results (indications, anthropometric measurements, mechanical ventilation and oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe University Ihsan Dogramaci Children's Hospital. results, accompanying other comorbidities, etc.).

NCT ID: NCT04050488 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Zinc Supplementation on Very Low Birth Weight Infant

Start date: August 20, 2019
Phase: Phase 4
Study type: Interventional

Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group. Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis. Zinc is one of the micronutrients which is very risky for deficiency in premature babies. Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased. The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.

NCT ID: NCT04035629 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

129Xe MRI in Pediatric Population With BPD

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder. As a nonionizing technique, MRI is an ideal modality for pulmonary imaging; in particular in the infant and pediatric population. Nevertheless, due to the low proton density of the lung parenchyma (only ~20% that of solid tissues), numerous air-tissue interfaces that lead to rapid signal decay, and cardiac and respiratory sources of motion that further degrade image quality , MRI has played a limited role in the evaluation of lung pathologies. In this setting, HP gas (using 129Xe) MRI may play a role in helping determine the regional distribution of alveolar sizes, partial pressure of oxygen, alveolar wall thickness, and gas transport efficiency of the microvasculature within the lungs of infants with a diagnosis of bronchopulmonary dysplasia (BPD).

NCT ID: NCT04019106 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Budesonide With Intratracheal Surfactants in Extremely Preterm Infants

BITS
Start date: October 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II trial in preterm infants aimed at identifying the optimal dose of budesonide with bovine lipid extract surfactant as vehicle for intratracheal administration.

NCT ID: NCT03855202 Not yet recruiting - Neonates Premature Clinical Trials

The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms

BPD
Start date: February 24, 2019
Phase: Phase 1
Study type: Interventional

Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems

NCT ID: NCT03683953 Not yet recruiting - Safety Issues Clinical Trials

The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

Start date: September 29, 2018
Phase: Phase 1
Study type: Interventional

To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD