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Infant, Newborn, Diseases clinical trials

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NCT ID: NCT06469580 Recruiting - Neonatal Disease Clinical Trials

Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the role of neonatologist-performed lung ultrasound (NPLUS) after weaning from invasive mechanical ventilation and extubation. Our aim is to study the diagnostic accuracy of NPLUS and investigate whether LUS leads to earlier actions before clinical deterioration and hence prevents extubation failure.

NCT ID: NCT06427642 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.

NCT ID: NCT06408480 Recruiting - Neonatal Disease Clinical Trials

Neonatologist-performed Lung Ultrasound in the Delivery Room

Start date: May 1, 2024
Phase:
Study type: Observational

The objective of this study is to evaluate the role of the neonatologist-performed lung ultrasound (NPLUS) during immediate transition after birth of late preterm and full-term neonates using the lung ultrasound score to predict the need of respiratory support persisting more than 1 hour after birth.

NCT ID: NCT06408064 Recruiting - Neonatal Disease Clinical Trials

The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate

Start date: May 3, 2024
Phase: N/A
Study type: Interventional

The admission of a newborn to the neonatal intensive care unit (NICU) represents a potentially harmful sound environment coupled with multiple stressful events. However, a strategy such as music therapy (delivered by a trained music therapist) appears to be a non-invasive, safe, and cost-effective alternative that assists newborns in their physiological self-regulation with a beneficial effect on stabilizing neonatal vital signs, so it can be used as a complementary strategy to medical management. The aim of this study is to determine the effect of live and pre-recorded music therapy on vital sign variables in newborns older than 32 weeks hospitalized in the neonatal intensive care unit of a high-complexity health institution in Colombia.

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: NCT06139809 Recruiting - Clinical trials for Intubation Complication

Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

IntubAID
Start date: March 31, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are: - Successful nasal intubation at the first attempt without physiological instability. - Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia. Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.

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: NCT05894798 Recruiting - Acupuncture Clinical Trials

Acupuncture in Infantile Colic - A Randomised Trial.

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

About 10 per cent of all new born babies in Sweden have infant colic. This may affect the the whole family and the early connection between the baby and the parents. Although, there are no effective and safe treatment. Acupuncture is an environmental friendly method that affects pain, anxiety, sleep and the function of gastrointestinal system. Several studies have shown various results, and there are a need for high-qualitative randomised controlled trials to investigate the proposed effect further. 128 children will be randomised into two groups; acupuncture at LI4 or no acupuncture, parents will be blinded. Statistical calculations will be performed on the content of the diaries (bowel movement frequency, crying time, feeding). Registration of crying/crying in connection with acupuncture treatment, i.e. when the needle touches the skin or later until the needle is removed and 30 seconds after.