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Neonatal Disease clinical trials

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NCT ID: NCT06263790 Not yet recruiting - Clinical trials for Intubation; Difficult or Failed

Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

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

The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure. This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.

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: NCT05892809 Completed - Nursing Caries Clinical Trials

Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: 91 neonates presenting to a neonatal intensive care unit who met the inclusion criteria were included in the study. Vital signs of neonates were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).

NCT ID: NCT05880433 Completed - Clinical trials for Retinopathy of Prematurity

The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

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

Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect. Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns. The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.

NCT ID: NCT05860166 Completed - Infant Development Clinical Trials

Development of a Scale for Evaluation of Neuromotor Development of Infants

Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Although the scales used so far provide information about the neuromotor progression of a single baby, it is thought that they are not sufficient to distinguish babies from each other, and it is thought that there is no assessment battery that will adapt to the knowledge in their conditions and the functional development of babies. Therefore, the aim of our study is to reveal the applicability and psychometric properties of the Neonatal Infant Motor Assessment Scale (NIMAS) test, which reveals the neurological and motor performance of infants hospitalized in the NICU, both as automatic responses and functional behavior.

NCT ID: NCT05845684 Completed - Clinical trials for Neurodevelopmental Disorders

The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit

Start date: December 31, 2021
Phase: N/A
Study type: Interventional

The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.

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.