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Infant, Newborn, Diseases clinical trials

View clinical trials related to Infant, Newborn, Diseases.

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NCT ID: NCT06255886 Not yet recruiting - Clinical trials for Gastroesophageal Reflux

Treatment of Gastroesophageal Reflux Disease in Infants

Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)

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: NCT06015828 Completed - Neonatal Disease Clinical Trials

Effect of Enteral Bovine Lactoferrin in Preterm Infants

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

There is a preference for using enteral bovine lactoferrin for preterm infants. Lactoferrin is a sialic acid-rich, iron-binding milk glycoprotein, known to have multifunctional health benefits, including its ability to modulate immune function and facilitate iron absorption, as well as its antibacterial and anti inflammatory actions. The study is an evaluation of the efficacy of enteral bovine lactoferrin on neurobehavioral performance in preterm infants.

NCT ID: NCT05954975 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Baby Sickness Evaluation

BeSurE
Start date: September 2023
Phase:
Study type: Observational

The goal of this prospective single center feasibility study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants > 6 months of age in order to aid the decision for referral to hospital. The emergency GP posts in Leiderdorp will add the BabyCheck and PO to their standard evaluation of infants presenting with systemic illness < six months of age for a period of six months. The feasibility will be determined by calculating the percentage of eligible infants in whom a complete BabyCheck score and PO data were retrieved. The investigators consider the protocol feasible if this is done in 80% of all eligible infants.

NCT ID: NCT05945017 Active, not recruiting - Infant Development Clinical Trials

Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers. Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.

NCT ID: NCT05936112 Not yet recruiting - Clinical trials for Functional Gastrointestinal Disorders

Quantification of Fecal Calprotectin Concentration Difference Between Infants Aged Under 4 Months Old Suffering From Functional Gastrointestinal Disorders (FGID) and Infants Aged Under 4 Months Old Free From Disorders : a Transversal Case-control Monocentric Study

Cal-IBS
Start date: September 2023
Phase: N/A
Study type: Interventional

There is a high prevalence of FGID among infants : 30 % for regurgitations, 20 % for colitis , 15 % for functional constipation.This represents a frequent motive for pediatrics consultation : 23 to 28 % of medical consultations in this population are consequent to gastrointestinal symptoms among infants aged under 4 months old. This can lead to numerous inappropriate or unrecommended medication prescriptions. Currently, fecal calprotectin threshold are only validated by science societies for children aged 5 years old and more. This study aims to quantify the difference of fecal calprotectin between a population of infants for whom no FGID has been finally detected, and a population of infants for whom FGID have been detected during the gastro-pediatrics consultation, , in order to later determine wether it is possible to validate a threshold in a population of infants aged under 4 months old.

NCT ID: NCT05907317 Not yet recruiting - Hypoxia Clinical Trials

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

SafeBoosC-IIIv
Start date: February 1, 2024
Phase: Phase 3
Study type: Interventional

The objective of the SafeBoosC-IIIv trial is to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. The hypothesis is that the intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.

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.