Neonate

10

Review clinical trials related to Neonate. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Point of Care - Sepsis Study

This pilot study will evaluate whether a rapid point-of-care blood test can help identify early signs of infection and sepsis in preterm infants. The study will include preterm infants born before 37 weeks of pregnancy who are admitted to the neonatal care unit and have a suspected infection. The researchers will measure several substances in the blood that can increase during infection, including interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP), and myxovirus resistance protein A (MxA). Results obtained with the point-of-care device will be compared with standard laboratory measurements. The researchers will also study whether measuring IL-6 and PCT during the first 12 hours of life may provide useful information about infection earlier than CRP testing and whether combined MxA and CRP measurements may help distinguish bacterial from viral infections. This is an observational study and will not change the infants' standard medical care or treatment. Results from the point-of-care device will not be used to make treatment decisions during the study. Blood samples will be collected as part of, or together with, routine blood sampling whenever possible. The study is expected to include approximately 40 preterm infants, with a maximum of 80 infants enrolled.

Participants needed: 80
Trial details
Biological sex: AllType: ObservationalSponsor: Medical University of GrazUpdated: Aug 19, 2026Locations: 1
Eligibility criteria

Preterm neonates born at <37+0 weeks of gestation who are admitted to the Divisi... [+1]

Term and preterm neonates who are not admitted to the neonatal care unit. [+1]

Status: Not yet recruiting

Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia

Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying intervention and compromising the effectiveness of treatments. Therefore, there is a need to develop new markers to develop preventive measures for the consequences of perinatal asphyxia. The primary objective is to compare cognitive and motor development at 18 months in three populations (PA, at risk of PA, and Control) defined on the basis of clinical, biological, and neural criteria.

Participants needed: 280
Trial details
Age: 1+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Jul 14, 2026Locations: 1
Eligibility criteria

Full-term infants (born between 36 and 42 weeks of gestation), clinically "norma... [+10]

Full-term newborn not meeting inclusion criteria

Status: Recruiting

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.

Participants needed: 240
Trial details
Age: 1-52Biological sex: AllType: InterventionalSponsor: Vinícius C Quintão, MD, MSc, PhDUpdated: Nov 25, 2025Locations: 3
Eligibility criteria

Pediatric patients requiring oral or nasal tracheal intubation for elective, sem... [+2]

Prediction of difficult intubation based on physical examination or a history of... [+2]

Status: Recruiting

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.

Participants needed: 100
Trial details
Age: Up to 50Biological sex: AllType: InterventionalSponsor: University of HelsinkiUpdated: Oct 8, 2025Locations: 2
Eligibility criteria

Healthy mother and healthy pregnancy [+4]

Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finl... [+7]

Status: Recruiting

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.

Participants needed: 60
Trial details
Age: Up to 3Biological sex: MaleType: InterventionalSponsor: Tanta UniversityUpdated: Jul 23, 2025Locations: 1
Eligibility criteria

Male infants less than 3 months old. [+1]

Male infants more than 3 months old. [+3]

Status: Recruiting

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.

Participants needed: 70
Trial details
Age: 1+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: May 28, 2025Locations: 1
Eligibility criteria

For healthy adult volunteers [+12]

Subject and Patients "not compatible" MEG. Wearers of prosthesis or pacemaker li... [+3]

Status: Not yet recruiting

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.

Participants needed: 140
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: University College DublinUpdated: Mar 27, 2025Locations: 1
Eligibility criteria

Neonates with an upper airway malformation. [+1]

Status: Recruiting

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.

Participants needed: 50
Trial details
Age: 0-12Biological sex: AllType: ObservationalSponsor: Leiden University Medical CenterUpdated: Mar 18, 2025Locations: 1Duration: 1 Day
Eligibility criteria

Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks... [+3]

Unilateral diaphragm paresis diagnosed by ultrasound [+5]

Status: Recruiting

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.

Participants needed: 100
Trial details
Age: Up to 2Biological sex: AllType: ObservationalSponsor: University of PecsUpdated: Feb 19, 2025Locations: 2
Eligibility criteria

For Substudy 1: Patients admitted to the Neonatal Intensive Care Unit at the Uni... [+2]

For both substudies: If the patient cannot be mobilized (e.g., during the post-o... [+2]

Status: Recruiting

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.

Participants needed: 10,000
Trial details
Age: 1-18Biological sex: AllType: ObservationalSponsor: University of Sao PauloUpdated: Dec 9, 2024Locations: 1
Eligibility criteria

All of the consecutive patients under 18-years-old who were admitted to particip...

patients undergoing radiological or other procedures that do not require general... [+1]