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Premature Birth clinical trials

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NCT ID: NCT04528030 Not yet recruiting - Hypoxia Neonatal Clinical Trials

A UK Interventional Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability

WAVE
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies, including retinopathy of prematurity (ROP), sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure ventilation, and caffeine therapy. The objective of this device is to provide an adjunct to current AoP treatment to support breathing in premature infants by using a simple, non-invasive vibratory device placed over limb proprioceptor fibers, an intervention using the principle that limb movements facilitate breathing. Methods Used: Premature infants (27+6 - 34+6 weeks GA) with clinical confirmed weeks with diagnosis of Apnoea of Prematurity. Caffeine therapy was not a reason for exclusion. Small vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were continuously collected.

NCT ID: NCT04519112 Not yet recruiting - Clinical trials for Premature Ventricular Contraction

Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

Start date: October 1, 2020
Phase: Phase 4
Study type: Interventional

This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.

NCT ID: NCT04505176 Not yet recruiting - Premature Birth Clinical Trials

Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent MIST Under HHHFNC or Nasal CPAP Methods

TCOPHC
Start date: November 30, 2020
Phase:
Study type: Observational [Patient Registry]

Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS) Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant. In our neonatal intensive care unit, respiratory support is given with nasal CPAP and Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies. During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies. In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. At the end of the study, all data will be entered in an SPSS (Statistical Package for the Social Sciences) file and study statistics will be made. A database will be created using SPSS software. A p value of <0.05 was determined as the limit of significance.

NCT ID: NCT04454502 Not yet recruiting - Clinical trials for Oral Colostrum Administration in Very Low Birth Weight Premature Infants

Analysis of the Effects of Oral Colostrum Administration in Premature Infants on the Breastfeeding

Oral colostrum
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

In the literature, it is emphasized that oral colostrum administration in very low birth weight infants supported the immune development of the premature newborn, contributed to the development of oral microbiota and reduced the length of hospital stay (Manzoni 2011; Pammi 2011; Zhang 2017; Moreno‐Fernandez 2018; Rodriguez 2009). However, there was no source answering the question of how both the mother and the infant are affected by oral colostrum administration in very low birth weight infants. Based on the studies indicating that premature infants distinguished their mother's milk smell and taste (Lecanuet and Schoal, 1996; Aoyama et al. 2010), it was aimed to find answers to the questions of whether this administration in infants without oral intake had positive effect on the success of breastfeeding. Research Hypotheses: H0: Oral colostrum administration in very low birth weight premature infants who cannot be fed orally has no effect on breastfeeding. H1: Oral colostrum administration in very low birth weight premature infants who cannot be fed orally affects the success of breastfeeding

NCT ID: NCT04361305 Not yet recruiting - Clinical trials for Erectile Dysfunction

Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction

Start date: June 3, 2020
Phase: Phase 3
Study type: Interventional

Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.

NCT ID: NCT04333121 Not yet recruiting - Pre-Term Clinical Trials

Modelling Weight Reference Centiles for Preterm Infants

Start date: December 1, 2020
Phase:
Study type: Observational

The aim of this study is to model longitudinal data at NICU of Assuit University Children Hospital to create predictive growth charts for weight in preterm infants from birth till discharge, that take into account the differing growth rates post-birth when compared to in-utero growth ,and to compare it with WHO chart for preterms.

NCT ID: NCT04277923 Not yet recruiting - Preterm Infant Clinical Trials

Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants

Start date: February 2020
Phase: Phase 4
Study type: Interventional

Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.

NCT ID: NCT04186728 Not yet recruiting - Clinical trials for Ventricular Premature Complexes

Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

Magnesium is a mineral which is essential to many of the processes which happen in the body. This includes normal function of muscles; including the heart. Studies have shown that oral magnesium supplementation can help reduce the frequency of extra heart beats (premature ventricular contractions (PVC) and premature atrial contractions (PAC)) while also reducing the severity of their associated symptoms. Oral magnesium supplementation has yet to be investigated in athletes with lots of PVCs and/or PACs. Most of the magnesium in your body is stored in the bones. Your body may take magnesium from your bones to maintain magnesium levels in your blood. This makes it possible for people to have low levels of magnesium in their body but normal levels in their blood. Over time, this process can decrease the total amount in your body and impact other body functions. Magnesium is also lost in sweat making athletes more vulnerable to having low levels in their body. Magnesium is particularly important in the function of the myocardium (heart muscle fibers). It has been proposed that the PVCs and PACs experienced by some people are a result of low levels of total body magnesium. Current drug treatments to control PVCs and PACs include medications such as beta blockers. These treatments are not without their side effects. Generally, these medications are only effective if individuals do not have a structural heart disease. These drugs may also decrease your ability to exercise and are banned by some governing bodies in sport. The hypotheses of this study are: 1. Oral magnesium supplementation reduces the frequency of PVCs and/or PACs. 2. Oral magnesium supplementation reduces the symptoms associated with PVCs and PACs. To be eligible for the study, individuals will be required to have a certain number of PVCs and PACs in a day. This study will involve two groups of participants. A total of 25 participants will be recruited for each group resulting in 50 participants in the study. During the study, one group will take a daily magnesium capsule for 12 weeks before switching to a placebo for 12 weeks. The other group will have the placebo intervention before switching to magnesium. Participants will be randomized into one of the two groups and will remain blinded until their participation in the study ends. The research team will also be unaware of each participant's current intervention however, this information will be available in case of medical emergency. Participants will be asked to attend one screening visit and three study visits. During these visits, a blood sample will be taken and you will be asked to complete questionnaires about you physical fitness and quality of life. You will also be asked to wear a Holter monitor for 48 hours in order to count the number of PVCs and PACs you have daily. In addition to these assessments, you will also complete an exercise stress test during your screening visit.

NCT ID: NCT04126382 Not yet recruiting - Preterm Infants Clinical Trials

LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants

Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of less invasive surfactant administration(LISA )technique in the treatment of neonatal respiratory distress syndrome(NRDS) by comparing with the traditional Intubate-Surfactant-Extubate(INSURE) technique.

NCT ID: NCT04104984 Not yet recruiting - Preterm Labour Clinical Trials

Detection of Preterm Labour by Cervical Length

Start date: February 15, 2020
Phase: Early Phase 1
Study type: Interventional

Detection of short cervix by transvaginal ultrasound and its evidence based management to prevent preterm birth .