View clinical trials related to Bronchopulmonary Dysplasia.
Filter by:The main goal of this trial is to test if: automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturation results in more stable blood-oxygenation compared to routine nurse controlled adjustment of oxygen
Bronchopulmonary dysplasia (BPD) is one of the most common morbidities in premature infants and is associated with poor neurodevelopmental outcomes . Although mechanical ventilation and oxygen requirements in premature infants have been identified as triggering mechanisms for the development of inflammation and BPD over time, data now support that a number of perinatal events that may stimulate the inflammatory cascade before birth also have important effects. Corticosteroids such as dexamethasone and hydrocortisone have proven to be beneficial for the prevention and management of postpartum BPD due to their anti-inflammatory properties . With this study, the effects of corticosteroid use on lung ultrasound findings in BPD will be investigated, and acute and chronic lung ultrasonography scores will be recorded. A prospective observational study was planned in the neonatal intensive care unit between 2022 and 2024 in premature infants below 32 weeks of gestational age. Demographic data and Lung Ultrasonography findings of these babies will be recorded. Among the patients who are predicted to go to BPD, in the group using corticosteroids, Lung Ultrasonographic imaging will be performed and the effect of corticosteroids on pulmonary findings will be recorded. It is planned to investigate whether postnatal steroid use has an effect on lung ultrasound findings in preterm infants with BPD.
Approximately 8% of all births occur between 30-36 weeks of gestation ('moderate-late' prematurity). Respiratory tract infections (RTI) and wheezing illnesses disproportionally affect preterm infants resulting in a 1.5-2 fold higher hospitalisation rate during the first years of life compared to term born children. Besides prematurity, several other postnatal modifiable influencing factors are associated with increased risk of respiratory morbidity and impaired pulmonary development. These factors include RTI, rapid weight gain, air pollution, tobacco smoke exposition, vitamin D deficiency, maternal stress and antibiotic usage. The investigators hypothesize that a follow-up program aiming at prevention of modifiable influencing factors can reduce respiratory morbidity in moderate and late prematurity. Objectives: To reduce respiratory disease burden in moderate-late preterm infants in the first 18 months of life
Although the majority of premature neonates < 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. [an 8-point difference is considered a clinically meaningful difference] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).
Objectiv: To compare the effect of intratracheal administration of surfactant vs. surfactant/budesonide on the incidence of bronchopulmonary dysplasia in preterm infants less than 34 weeks of gestation. Material and methods: Study design: Double-blind randomized controlled clinical trial.Inclusion criteria: Newborns under 34 weeks of gestation with a diagnosis of Respiratory Distress Syndrome requiring administration of surfactant, invasive and/or non-invasive ventilatory support admitted to the Neonatal Intensive Care Unit service and pathological nursery. Procedure: 328 patients will be included from Group A: 164 patients, from Group B: 164 patients who meet the selection criteria within the first 4 hours of hospital stay, after the authorization of the parents or guardian signing the informed consent. According to the assigned group, the preparation of surfactant or surfactant/budesonide in the syringe will be carried out, prior to performing the tracheal cannulation procedure. Group A will be given surfactant (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) at a dose of 100mg/kg or 4ml/kg and budesonide (budesonide, nebulized suspension 2ml contains 0.500mg) at a dose of 0.250 mg/kg or 1 ml/kg. Group B will receive surfactant alone (beractant, lung phospholipids of bovine origin. Injectable suspension 1ml contains 25mg) administered at a dose of 100mg/kg or 4ml/kg. Subsequently, follow-up will be carried out at 12 hours to assess the administration of the second dose of surfactant, type of mechanical ventilation, inspired fraction of oxygen (Fi02), arterial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2 ), mean airway pressure (PMVA), oxygen index (IO), oxygen saturation by pulse oximetry, weekly follow-up of the patient will continue for 28 days, evaluating the same parameters to make a diagnosis of bronchopulmonary dysplasia and finally at 36 postmenstrual weeks of gestation in those under 32 SDG or at discharge and at 56 postmenstrual days of life in those over 32 SDG or at discharge, allowing the severity of the disease to be determined.Sample size: The study includes an intervention group (surfactant/budesonide group) and a control group (surfactant only group), each with 164 patients, for a total of 328 patients. Statistical analysis: The Chi-Square statistician will be used with a precision requirement of 95%, where p<=0.05. The risk measurement will be with RR (RR) and its 95% confidence interval (CI). NICSS 2007 statistical package will be used. Ethical aspects: This study must have an authorization signature through informed consent.
Introduction: The caffeine is used in the treatment for apnea of prematurity and it has several positive effects in the neurodevelopment of preterm babies. There are innumerable observational studies suggesting that initiating caffeine in the first hours of life may offer more benefits in the reduction of the necessity of intubation and in ventilation time. It is necessary to expand further research on the best time to start caffeine, which may improve the quality of care for premature infants. Objective: To evaluate the benefits of caffeine administration in the first two hours of life compared to administration at 24 hours of life in premature patients on noninvasive mechanical ventilation with birth weights less than 1250 grams. Methodology: Preterm newborn patients with birth weight < 1250 grams born at Hospital de Clínicas de Porto Alegre who are not intubated in the delivery room will be included. Patients will be randomized into two groups. One arm of the study will receive caffeine at 2 hours of age and the other arm will receive caffeine at 24 hours of age (control). Patients in the control group will receive 0.9% SF at 2 hours of life in order to keep the study blinded. The following outcomes will be evaluated: need for intubation, time on invasive and non-invasive mechanical ventilation, BPD, necrotizing enterocolitis, need for ROP treatment, PDA with hemodynamic repercussions, peri-intraventricular hemorrhage, leukomalacia and death. The sample size calculation is 50 patients, 25 in each arm. Expected Results: It is expected to find a 43% reduction in the need for intubation in preterm infants who receive caffeine in the first two hours of life compared to administration at 24 hours of life. It is also expected to find a reduction in mechanical ventilation time, in addition to a possible reduction in negative outcomes associated with prematurity.
The purpose of this study is to investigate the effects of the Pacifier Activated Lullaby (PAL) intervention on the transition to oral feeding for preterm infants with chronic lung disease and respiratory distress syndrome that require non-invasive respiratory support at 34 weeks PMA. This study will utilize a clinical trial design. Participants will be randomized into two groups. One group will receive the PAL intervention, the other group serving as a no contact control. Participants will be matched based on sex, gestational age at birth, and neurologic injury. Infants in the intervention group will receive two PAL sessions a week until successfully transitioned to <2L of respiratory support and then receive one PAL session within 24 hours of their first oral feeding attempt.
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 24-27 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.