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Infant, Premature clinical trials

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NCT ID: NCT06416956 Recruiting - Caffeine Clinical Trials

Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Baby-CINO
Start date: December 11, 2023
Phase:
Study type: Observational

This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.

NCT ID: NCT05808088 Recruiting - Sleep Clinical Trials

The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The goal of this randomised study is to learn about, the effect of hypnotherapeutic sound-files on the sleep of parents of infants in the neonatal unit. The main questions it aims to answer are: - Can hypnotherapeutic sound-files make parents of infants in the neonatal unit sleep longer and better? - Does hypnotherapeutic sound-files effect the state anxiety score of parents of infants in the neonatal unit? Participants will have access to sound-files and: - wear actigraphy sleep registration - complete state-trait anxiety score

NCT ID: NCT05427929 Recruiting - Infant, Premature Clinical Trials

Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance

Start date: January 12, 2023
Phase: N/A
Study type: Interventional

Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. NAVA was introduced to the market in 2007 and since has been used in more than 40 countries. In the current clinical practice, the Edi signal from the patient is captured with miniature sensors (the size of a hair) embedded in the wall of a specially designed naso/orogastric feeding tube. This FDA and Health Canada approved, commercially available catheter (Getinge, Solna, Sweden), is 6 Fr in size (outer diameter), 49 cm in length and has 8 pairs of sensors that are placed 6 mm apart (so-called inter electrode distance (IED) is 6 mm). While no obvious side effects have been noted by clinicians, for the smallest of neonates, the currently used commercial catheter (size 6F, 49 cm long) may have 'excessive' post-array catheter length. In these neonates, typically those with weight < 750 grams, following the correct placement of catheter as per the electrode array positioning at gastro-esophageal junction, the feeding holes in the catheter may end at the level of distal stomach instead of the desirable mid-stomach location. The changing demographics of the patients in the Neonatal Intensive Care Units (NICU) has created a clinical need to redesign the currently used Edi catheter specifically to suit the smallest of patients, such that following adequate placement the feeding holes sit at the level of mid-stomach. Drs. Christer Sinderby and Jennifer Beck in Toronto, Canada, are the original designers of the 6 mm/49 cm currently used Edi catheter. These investigators (at St-Michael's Hospital, Toronto) in collaboration with their team at Neurovent Research Inc. (NVR) have re-designed and invented a new prototype of the current FDA-approved catheter specifically suited for use in extreme premature neonates. They have done so by reducing the interelectrode distance from the originally set 6 mm to 4 mm, which reduces the overall insertion depth to capture the same signal from the diaphragm. All other parameters are exactly same as the original catheter (6F, 49 cm long). In this small feasibility study the investigators wish to provide a clinical proof of concept for the use of this newly designed prototype in 10 extremely premature neonates who are already receiving NAVA ventilation in the NICU.

NCT ID: NCT05335577 Recruiting - Infant, Premature Clinical Trials

Role of Urinary Claudin-2, Caveolin-1, and EGF as Diagnostic Biomarkers of Necrotizing Enterocolitis in Preterm Neonates

Start date: March 17, 2022
Phase:
Study type: Observational [Patient Registry]

Our study aims to determine the differences in the concentration of urinary claudin-2, caveolin-1, and epidermal growth factor (EGF) as non-invasive biomarkers in the diagnosis of Necrotizing Enterocolitis (NEC). We compare the concentration of urinary claudin-2, caveolin-1, and EGF between preterm neonates at risk of NEC and healthy term infants as the basis for determining NEC biomarkers with the most optimum sensitivity and specificity. This analytical observational study is based on biomolecular profiling with a prospective cohort design approach. The research subjects are a group of preterm neonates (gestational age of 28-34 weeks) who were admitted in Perinatology Unit, Department of Pediatrics, Saiful Anwar General Hospital, Malang and whom diagnosed with NEC using Bell's criteria and serum TGF-β levels. Subjects are selected by consecutive sampling and single-blind analysis was performed in the Laboratory of Bioscience and Biomedicine, Faculty of Medicine, University of Brawijaya. During the research process, groups of preterm and term neonates would be observed and their clinical development followed. The collection of biologic samples would be taking 10 cc of urine and 40 mg of feces on day-5 (D5) and 7 (D7). The consecutive manner of urinary sampling was regarded to assess whether there was a time-related protein expression in the course of the NEC process. Faecal samples would be assessed for microbiota profile analysis described by the ratio of Proteobacteria: Firmicutes and Bacteroidetes to represent dysbiosis process in NEC. After 7 days, the subjects would be grouped into a group of preterm neonates with NEC, a group of healthy term neonates as a control, while a group of preterm infants at whom during the course of the study did not develop NEC, would be assigned to group of premature neonates without NEC. Urinary protein concentrations from the three groups would then be analyzed and adjusted with normalized creatinine, so that the levels of these three proteins could be assessed quantitatively using the ELISA (Enzyme-Linked Immunosorbent Assay) method. The results would be compared with the microbiota profile as the golden standard for NEC cases. Through statistical tests, sensitivity, specificity and cut-off of selected protein levels would be assessed as diagnostic biomarkers of NEC.

NCT ID: NCT03693287 Recruiting - Growth Clinical Trials

Personalized vs Standardized PN for Preterm Infants >1250g

Start date: July 4, 2021
Phase: Phase 4
Study type: Interventional

Preterm infants (gestational age between 189 and 258 days) with a birth weight (BW) greater than 1250 grams will be randomized to personalized-parenteral nutrition (P-PN) or standardized-parenteral nutrition (S-PN). The aim of the study is to evaluate the effect of S-PN versus P-PN on growth of preterm infants with BW>1250 grams.

NCT ID: NCT03521063 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline.

NCT ID: NCT03501485 Recruiting - Infant,Premature Clinical Trials

Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.

Start date: December 18, 2017
Phase:
Study type: Observational

Resting Energy Expenditure is the amount of energy, usually expressed in Kcal required for a 24 hour period by the body during resting conditions. It is closely related to, but not identical to, basal metabolic rate. According to the ESPGHAN committee guidelines on enteral nutrient supply for preterm infants, which were published in 2010, the daily protein intake of extremely low birth weight infants shall be 4.5 g/kg/day, and for those above 1000g, 4 g/kg/day. In order to meet these recommendations, the human milk for all premature infants is enriched with human milk fortifier, and supplemental liquid protein according to our NICU protocol. Little is known on the effect of this enrichment on the basal metabolic rate of premature infants. One way of determining the basal metabolic rate is by measuring the resting energy expenditure. In order to do that the investigators use an indirect calorimety by using the Deltatrac II metabolic monitor (Datex-Ohmeda). This instrument uses the principle of the open-circuit system that allows continuous measurements of oxygen consumption and carbon dioxide production using a constant flow generator.

NCT ID: NCT03456336 Recruiting - Infant, Premature Clinical Trials

Management of the PDA Trial

PDA
Start date: December 3, 2018
Phase: Phase 3
Study type: Interventional

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.

NCT ID: NCT02811029 Recruiting - Infant, Premature Clinical Trials

Language and Motricity in Preterm School Age Children

LAMOPRESCO2
Start date: July 2016
Phase: N/A
Study type: Interventional

A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure. Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders, executive function disorders as well as attention and behaviour disorders. Developmental language disorders have been rarely reported in the literature. This originally prompted our request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol has studied the language development of children who were born very prematurely, aged 3 and a half years free of cerebral palsy, in particular the impact of a short rehabilitation period, precise, at an early stage, and protocolized on a fundamental sensorimotor language. The principal assessment criterion was the measurement of phonology, the cornerstone of oral and written language in humans. The aim of the present project is an analysis of the effect that this specific language stimulation has on the learning of written language. The hypothesis is that a specific work modifying various aspects of a child's language, during the age of 3 to 4, alters the development of phonological skills in a sustainable way. The acquisition of reading skills is basically dependent on the quality of its phonological components. The randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing difficulties have been reported as regards the language understanding of 3 to 15 year old children. It is as if the initial difficulties and weaknesses, which moreover constituted oral language, prevented the use or development of neural networks, which became more complex and required both an oral and written language. Are these elements which constitute phonology, at an early stage, modifiable before the close of the clinically measurable developmental window?

NCT ID: NCT01552993 Recruiting - Infant, Premature Clinical Trials

Registration and Treatment of Pain During Eye Examination of Prematurity

Start date: March 2012
Phase: N/A
Study type: Interventional

The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.