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Neonatal Disease clinical trials

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NCT ID: NCT06258187 Recruiting - Neonatal Disease Clinical Trials

Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room

CO2-Vent
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation. A randomization generator will assign each month either using the Pedi-Cap or not using the Pedi-Cap. The researchers will collect information from the chart to find the infant and mother's information, vital signs, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room PPV.

NCT ID: NCT06206590 Recruiting - Neonatal Disease Clinical Trials

Analysis of Differential Proteins and Maternal Influencing Factors of Septic Shock in Neonates

Start date: November 1, 2023
Phase:
Study type: Observational

1. Explore 32 weeks of premature infants or maternal pregnancy infection of newborn septic shock maternal influence factors. 2. Through maternal blood samples before delivery and labor cord blood sample screening and septic shock related proteomics analysis, explore the relationship between the difference protein and septic shock and prognosis, and explore the pathway mechanism, in order to prevent and reduce the occurrence of septic shock in premature infants

NCT ID: NCT06087315 Recruiting - Sepsis Clinical Trials

Evaluation of a Multi-country Medical Oxygen Program

REAL-MOXY
Start date: November 27, 2023
Phase:
Study type: Observational

REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for beneficiaries, users and managers.

NCT ID: NCT05896306 Recruiting - Neonatal Disease Clinical Trials

Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates

pNIRS
Start date: May 30, 2023
Phase:
Study type: Observational

The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. To objectify the condition of the newborn during this vulnerable transitional period, Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score, which is widely used around the world. However, there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score. To objectively assess the condition of the newborn, the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse oximetry in the delivery room in addition to clinical evaluation. These monitoring methods allow non-invasive continuous monitoring of SpO2 (Oxygen saturation) as well as heart rate (HR), but do not provide information about potentially compromised cardiovascular status, resulting in severely restricted oxygen transport to tissues. Cerebral Oxygenation: The brain is one of the most vulnerable organs to hypoxia during the postnatal adaptation period. The recommended routine monitoring during the neonatal transition is SpO2 and heart rate. Unfortunately, these parameters do not provide any information about cerebral blood flow or oxygen supply or brain activity. About 30% of premature babies develop cerebral hemorrhage in the first 3 days after birth. This can lead to the development of hydrocephalus, poor neurological outcome and even death. For the above reasons, there is increasing interest in additional brain monitoring. Our research group has already shown in various studies that additional cerebral monitoring using near-infrared spectroscopy (NIRS) is possible in newborns immediately after birth and may be beneficial during this vulnerable phase of life. Furthermore, this add-on monitoring could inform interventions to optimize brain oxygenation, potentially affecting survival with improved short- and long-term neurological outcomes. Background: The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge. Initial evaluation of neonates is usually based on visual inspection, palpation and/or auscultation, and response to stimuli. To objectify the condition of the newborn during this vulnerable transitional period, Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score, which is widely used around the world. However, there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score. To objectively assess the condition of the newborn, the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography (ECG) and pulse oximetry in the delivery room in addition to clinical evaluation. These monitoring methods allow non-invasive continuous monitoring of SpO2 as well as HR, but do not provide information about potentially compromised cardiovascular status, resulting in severely restricted oxygen transport to tissues. Pulsatile mode of NIRS Recently, Hamamatsu developed new software and implemented it as a pulsatile mode in one of their near-infrared spectroscopy (NIRS) instruments, the NIRO 200 NX. In contrast to the conventional NIRS technique, which measures tissue saturation closer to venous oxygen saturation than arterial oxygen saturation, the pulsatile NIRS technique uses a higher measurement rate of 20 Hertz and can therefore measure cerebral pulse rate (cPR) and cerebral arterial oxygen saturation (SnO2) in small vessels. Using the non-invasive pulsatile NIRS technique could be a viable new method to continuously monitor blood flow to the brain during resuscitation. This can be particularly beneficial for critically ill newborns and premature babies. To date, no data have been published in neonates using the pulsatile NIRS technique.

NCT ID: NCT05762835 Recruiting - Pediatric Disorder Clinical Trials

Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.

NCT ID: NCT04920175 Recruiting - Neonatal Disease Clinical Trials

Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit

Start date: September 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to collect data to develop a complete package (hardware, user interface software and algorithms) that can monitor sleep-wake stages in neonates. Real-time EEG data will be used to develop and refine the prototype monitor's ability to provide direct real-time information about sleep-wake state. The study design includes multiple iterative training/testing stages to refine the prototype. The study is divided into multiple sub-aims conducted in parallel: data acquisition, algorithm development (including comparison between gold-standard polysomnogram vs. novel algorithm markings of sleep-stages), and graphical user interface software development. The data acquisition and algorithm development are iterative and linked, such that the prototype algorithm from one iteration will be deployed real-time during the next iteration of data acquisition. This allows verification that the algorithm can perform real-time and provides prospective testing data, which is later folded into the training data for the next iteration, for verification and validation of the system.

NCT ID: NCT04822142 Recruiting - Neonatal Disease Clinical Trials

Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

CYMEVIE
Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population

NCT ID: NCT04401540 Recruiting - Healthy Clinical Trials

Characteristics of Neonatal Covid-19 in Turkey

Start date: May 1, 2020
Phase:
Study type: Observational [Patient Registry]

The investigators aimed to investigate the clinical and epidemiological characteristics of neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric prospective cohort study designed and destined only in Turkey. The investigators are planning to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total number may change according to the prevalence of Covid-19 in neonates. The investigators will also inquire into vertical transmission by collecting cord blood, placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG values from the neonates.

NCT ID: NCT04074824 Recruiting - Clinical trials for Necrotizing Enterocolitis

A Genome-Wide Association Study for Neonatal Diseases

Start date: September 1, 2018
Phase:
Study type: Observational

This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation. We hypothesize that specific genetic factors and microbiome could predispose preterm neonates for the development of NEC.