Clinical Research Directory

Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC

This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population at high risk of mpox infection. The study will be conducted in Boende, Tshuapa Province, DRC. A total of 359 maternal participants, aged 16 to 35 and in their second or third trimester of pregnancy, will be enrolled. Participants will be randomly assigned to receive two subcutaneous doses of the MVA-BN vaccine, given 28 days apart, either during pregnancy (Maternal Group 1) or within 72 hours after delivery (Maternal Group 2). Additionally, pregnant women in any trimester who have been recently exposed to a confirmed mpox case will be enrolled in the post-exposure prophylaxis (PEP) arm (Maternal Group 3), receiving the vaccine as soon as possible after exposure-ideally within four days but up to 14 days if they remain asymptomatic. The study will evaluate the safety, reactogenicity, and immune responses of vaccinated pregnant women compared to healthy adults in the POX-MVA-045 study (NCT06549530) through non-inferiority analyses. Participants will be monitored for immunogenicity and safety for 13 months post-delivery, while neonates will be observed for safety over the same period. The trial will also compare outcomes between women vaccinated during pregnancy and those vaccinated postpartum, assess the transfer of maternal immunity to neonates, and explore correlations between maternal antibody levels in serum and breast milk. This study seeks to provide strong evidence supporting the safety and immunogenicity of the MVA-BN mpox vaccine in pregnancy, contributing to global public health efforts to protect at-risk women and their infants in mpox-endemic regions.

SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation

Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \<80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time. This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.

Infant Microbiota Restoration With Maternal Microbes

The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is: Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants. Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.

Dilemma of Neonatal Circumcision in Egypt

The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.

Magnetoencephalography by Optical Pumping Magnetometer

MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling. The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.

An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.

This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly. The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency. In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today. The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.

Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support

Background of the study: Increased work of breathing, potentially leading to respiratory insufficiency, resulting in the need of (non-) invasive respiratory support is the most common observed problem in the neonatal - and pediatric intensive care unit (NICU/PICU). The diaphragm is the main respiratory muscle. Currently there is not an established technique accessible to observe the (clinical) function of the diaphragm and its role in respiratory insufficiency. New non-invasive modalities are promising, such as transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS). Objective of the study: Our objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population. Study design: Single center pilot study Study population: The study population consists of children between 0-12 months, admitted to the PICU of the Leiden University Medical Center, with invasive respiratory support. Primary study parameters/outcome of the study: Primary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU population.

Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates

Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue. The development of this thermogenic tissue starts around the 26th gestational week and continues until shortly before birth, after which no further growth occurs. As a result, premature infants, who have less developed brown fat, are more prone to reduced heat production and are at higher risk for hypothermia. There are few human studies examining the thermoregulatory differences and mechanisms between full-term and premature neonates, and the findings remain inconclusive. In this study, the investigators aim to conduct a prospective, observational research. Researchers will compare body temperature, brown adipose tissue activity, and specific plasma markers between full-term and premature neonates in insensive care units and during elective surgeries.

Latin American Surgical Outcomes Study in Pediatric Patients

This prospective, international, multicenter observational study will include hospitals performing pediatric surgery in participating Latin American countries. We aim to assess the incidence of hospital postoperative complications in pediatric surgical patients \< 18-years-old in Latin America. We will recruit all consecutive pediatric patients under the age of 18 years who were admitted to participating hospitals undergoing elective and nonelective surgery. The primary outcome is in-hospital postoperative complications up to 30 days after surgery.