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Asphyxia clinical trials

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NCT ID: NCT05308303 Active, not recruiting - Trauma Clinical Trials

AI to Improve Data From Danish Cardiac Arrest Registry

Start date: June 1, 2022
Phase:
Study type: Observational

Out-of-hospital cardiac arrest is a leading cause of death worldwide and patient outcome vary substantially throughout regions suggesting further evaluation and potential for improvement.When focussing on subgroups of OHCA, data in certain areas remains scarce and the need of revised guidelines is evident. Furthermore, enhanced knowledge on these varieties of OHCA's apply to substantial number of patients, also among vulnerable populations. The Danish Emergency Medical System introduced a nationwide registry of electronic medical reports in 2016. This report system allows electronic searches and thereby the opportunity to identify subgroups of OHCA's. Thus, this novel reporting enables the evaluation of new characteristics of cardiac arrests of non-cardiac origin, in cases where an automated external defibrillator (AED) is retrieved but did not recommend defibrillation and finally in OHCA related to foreign body obstruction. With the advantages of artificial intelligence, this project will enhance and strengthen data from the Danish Cardiac Arrest Registry. It may substitute the manual validation of the around 9000 cases per year in Denmark. Further, it proposes improvement of quality and development of observational health research.

NCT ID: NCT05275725 Recruiting - Birth Asphyxia Clinical Trials

Finding Solutions to Thrive After Birth Asphyxia in Africa

SANE-Uganda
Start date: July 1, 2022
Phase: Phase 1
Study type: Interventional

Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide. In low-income countries (LICs), families often lack the resources to care for affected children. For those with disabilities, stigma is high, and social and emotional impacts are substantial. Improving our understanding of NE in LICs is crucial if intervention strategies are developed. Providing access to an affordable and easy-to-administer treatment after birth may improve survival, early brain development and later outcome, maximizing developmental potential. The primary objective of this study is to investigate the feasibility, safety and tolerability of administering sildenafil as a neuroprotective/neurorestorative strategy to improve early brain development in a cohort of children with NE in Uganda.

NCT ID: NCT05217199 Completed - Infant Development Clinical Trials

The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2

highrisk
Start date: April 15, 2022
Phase:
Study type: Observational

In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus. During the critical period of brain development, this sensory overload affects the physiological responses of infants; It can lead to sensory processing problems by causing negative changes in motor, neurological and sensory development. Sensory processing was explained by Dunn as the emergence of appropriate reactions and behaviors in neurological processes in which visual, auditory, tactile, oral, olfactory, vestibular, proprioceptive and kinesthetic inputs are regulated.

NCT ID: NCT05217186 Completed - Cerebral Palsy Clinical Trials

Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements

highrisk
Start date: September 15, 2020
Phase:
Study type: Observational [Patient Registry]

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neuroimaging and neurological examinations and assesments like neonatal imaging, general movements (GMs) and Hammersmith Infant Neurological Examination (HINE).

NCT ID: NCT05217056 Completed - Cerebral Palsy Clinical Trials

Associations Between General Movements Assessments and Cognitive Development

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

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP and learning diffuculties which can be observed in high-risk infants, is based on the combination of some neurological and clinical signs.

NCT ID: NCT04867993 Recruiting - Asphyxia Neonatorum Clinical Trials

Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia

Amicool
Start date: August 28, 2018
Phase: N/A
Study type: Interventional

As a part of a project on perinatal clinical pharmacology, the primary aim of the present project is to study amikacin pharmacokinetics (PK) and physiology in asphyxiated neonates treated with therapeutic hypothermia and to provide amikacin dosing recommendations, which will be validated prospectively. For this purpose, we aim to first collect retrospective data on amikacin available in neonates treated with hypothermia in the neonatal intensive care unit (NICU)s in Leuven and Amsterdam, and consequently to propose the dosing regimen to be used in the prospective amikacin PK study at our NICU in University Clinical Center (UCC) Sarajevo. At our NICU we aim to collect amikacin PK observations and other covariates in at least 40 neonates while treated with hypothermia and after re-warming period (a paired analysis), and in asphyxiated neonates not treated with hypothermia (control group). We hereby will use a stepwise approach, as initially used to develop and to validate an amikacin dosing regimen in preterm and term neonates (De Cock RFW et al., 2012, Smits A et al, 2015). A 3-step approach will be used, of which different parts will be conducted in different contributing hospitals: 1. Retrospective evaluation of amikacin therapeutic drug monitoring (TDM) in asphyxiated neonates treated with hypothermia (University hospital Leuven, VUmc Amsterdam) 2. Development of population PK model derived amikacin dosing recommendation 3. Prospective PK study with validation of the new dosing regimen (UCC Sarajevo, UCC Tuzla)

NCT ID: NCT04820504 Completed - Birth Asphyxia Clinical Trials

Augmented Infant Resuscitator to Enhance Newborn Ventilation

AIR
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment. AIR monitors ventilation quality and provides real-time objective feedback and actionable cues to clinicians to both shorten training times and improve resuscitation quality, adoption, retention, and confidence.

NCT ID: NCT04714775 Recruiting - Asphyxia Neonatorum Clinical Trials

Biomarkers And Neurological Outcome in Neonates 2

BANON2
Start date: February 5, 2019
Phase:
Study type: Observational

Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

NCT ID: NCT04714502 Active, not recruiting - Birth Asphyxia Clinical Trials

Asphyxia Associated Metabolite Biomarker Investigation 2

AAMBI2
Start date: July 2, 2019
Phase:
Study type: Observational

Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.

NCT ID: NCT04369313 Recruiting - Clinical trials for Gestational Diabetes Mellitus

Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour. Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs. Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.