Clinical Research Directory

Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?

The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk of chronic lung disease associated with prematurity. Only babies who meet treatment criteria will receive this medication. Babies who do not meet treatment criteria will not receive medication. The main questions it aims to answer are: * Does betamethasone make it easier for babies to come off a breathing machine? * Does betamethasone cause any harmful side effects on growth or development? All babies in this study will: * Receive standard NICU care, with or without betamethasone * Have their progress, growth, and development followed over time

Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants

What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for infants who are born at or after 29 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer breathing-related problems and fewer short-term complications than those who receive it using the LISA method. What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?

Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome

Respiratory distress syndrome (RDS) is a common cause of respiratory failure in preterm infants and is frequently treated with surfactant therapy. With the increasing use of noninvasive ventilation, less invasive methods of surfactant administration have been developed. In the technique known as Less Invasive Surfactant Administration (LISA), surfactant is delivered into the trachea through a thin catheter, without the need for endotracheal intubation. This approach may reduce lung injury and improve respiratory outcomes in spontaneously breathing preterm infants. This multicenter, prospective, randomized study aims to compare the clinical effectiveness of poractant alfa and calfactant when administered using the LISA technique in preterm infants born at less than 30 weeks' gestation with RDS who are not intubated. The study will evaluate short-term outcomes, including the need for intubation, repeat surfactant administration, and respiratory support during the first 72 hours of life, as well as longer-term outcomes such as bronchopulmonary dysplasia and other neonatal morbidities.

Components of Mechanical Power on the Functional Lung in ARDS

Mechanical power (MP) is a composite variable that integrates static and dynamic respiratory parameters and has been associated with ventilator-induced lung injury (VILI). MP is predominantly delivered to the reduced functional lung size, commonly referred to as the "baby lung" (BL). Functional lung size, in turn, is closely related to respiratory system compliance (Crs). Previous studies have demonstrated an association between MP normalized to compliance (MP/Crs) and mortality. Moreover, evidence suggests that VILI associated with MP/Crs results primarily from the combined effect of its components rather than from any single component in isolation. The objective of this study is to evaluate both the overall and the relative contribution of each component of mechanical power, normalized to compliance (MP/Crs), to in-hospital mortality in patients with acute respiratory distress syndrome (ARDS).

Using Artificial Intelligence Models for Predicting The Need for Intubation and Successful Weaning From Mechanical Ventilation in ICU Patients

Using artificial intelligence (AI) approach to build a model to determine the optimal timing of intubation and optimal timing of weaning from MV for ICU patients, and compare outcomes with these which depend on clinicians dicision. And also assess whether AI-assisted decisions improve patient outcomes (e.g., reduced intubation delays, shorter ventilation duration).

Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol

Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given. A sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications. However, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients. Aims: * To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients. * To develop a sedation protocol for ECMO patients with input from patients, their family, and staff. Design/methods: Study 1: The investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2. Study 2: The investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group. Patient and public involvement/engagement: The investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public. Impact/dissemination: The investigators will share findings through social media, patient charities, research papers and conferences.

Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome. Secondary objective is to compare different respiratory support mode performance in different gestational age groups. Primary endpoint is treatment failure. With this study, the following hypotheses will be tested: Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.

Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy

The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need. The main question it aims to answer is: When a baby's oxygen requirement goes up, does NPLUS help to target interventions and reduce oxygen requirements? Researchers will compare NPLUS to standard treatment. Participants will: Have a lung ultrasound performed whenever their oxygen requirement increases by more than 10%. The ultrasound findings will be used to target interventions that aim to improve air entry in the lungs. Each time this happens, the researchers will note what happens to the oxygen requirement afterwards. Each participant will participate for five days. For the first two days, they will be randomized to either the NPLUS arm or the usual care arm. There is then a 24 hour period of usual care. For the final two days, participants cross over to the other arm of the trial.

SerpinB3 Expression, PAR2 and SCCA-PD Polymorphism in Acute Respiratory Distress Syndrome

The Acute Respiratory Distress Syndrome (ARDS) is a systemic syndrome characterized by severe respiratory failure, inflammation, loss of aerated tissue and high mortality. Recently, significant efforts have been made to phenotype ARDS patients through a wide range of new biomarkers and imaging indices with the goal of developing personalized treatments based on patient's biophenotypization. Recent literature demonstrates, both in vitro and in vivo but not yet in ARDS patients, that the serine protease inhibitor(SERPIN)-B3 plays a crucial role in the pathological mechanism of pulmonary fibrogenesis, and, similarly, protease-activated receptors(PAR2) is highly involved in this aberrant inflammatory response. Consequently, studying the expression of SERPINB3 (including SCCA-PD polymorphism) and PAR2, in association with a detailed clinical and biomolecular phenotypization, could allow new insights into the pathophysiological mechanisms of lung injury during ARDS.

A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants

Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope. The investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.

Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy

Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline.