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Premature clinical trials

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NCT ID: NCT06082674 Completed - Premature Clinical Trials

Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.

NCT ID: NCT06072625 Not yet recruiting - Premature Clinical Trials

Enteral Feeding of Premature Babies and Olive Oil Supplementation

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

It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding. Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values. Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.

NCT ID: NCT05968586 Recruiting - Premature Clinical Trials

Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

NCT ID: NCT05948098 Completed - Pain Clinical Trials

Facilitated Tucking Position, Gentle Human Touch Practices and Pain

Start date: July 20, 2023
Phase: N/A
Study type: Interventional

This prospective study is planned as a randomized controlled study to evaluate the effect of facilitated tucking position and gentle human touch practices on the pain experienced by newborns during heel blood collection. This study is planned to be carried out between 15 July and 15 December 2023 in the neonatal intensive care unit of a training and research hospital in the Southeastern Anatolia Region. The sample size was calculated based on the study of premature infants to determine the effect of facilitated tucking position on procedural pain. According to the results of the study, PIPP pain scores were determined as 11.88±3.05 in the intervention group (n=17) and 9.06±2.95 in the control group (n=17). The effect size of the study was determined as d= 0.939 at α=0.05 level and 95% confidence interval. It was decided to conduct the study with a total of 90 premature babies, 30 of whom were in the groups, in case of data loss during the study.

NCT ID: NCT05865977 Recruiting - Premature Clinical Trials

dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Start date: February 25, 2023
Phase:
Study type: Observational

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

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: NCT05853991 Not yet recruiting - Premature Clinical Trials

Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

Start date: June 2023
Phase: N/A
Study type: Interventional

Improving the quality of life of preterm children by 2035 is the top priority of worldwide health organisations, including the WHO. Every year, 15 million preterm infants, particularly those under 32 weeks of age, are at significant risk of neurocognitive impairments with adverse health consequences (disability, developmental delay, disease), exacerbated by the lack of post-hospital care for newborns. Intervening on the health of the preterm newborn through certain types of "touch" from its first days of life to activate its cutaneous senses permits, in reality, a significant improvement in the clinical state of the infant, hence promoting its growth, development, and social behaviour. In the neonatal period, during which significant neurological development occurs, tactile interactions and close physical proximity between infants and caregivers have significant short-term effects on the health of premature infants (weight gain, brain and vision development) and medium- to long-term effects on their development and expression of sociability. The likelihood that a premature newborn may develop attention and autism spectrum disorders, brain, gastrointestinal, and respiratory difficulties, as well as sleep disorders during the preschool years, is so high that clinical and social settings must prioritise care. Utilizing functional magnetic resonance imaging (fRMI), computerized electroencephalogram (EEG), and metabolomics, the research aims to explore the effects of touch, including physiotherapy and manual therapy (OMT) approaches, on brain activity. This research intends to examine the impact of touch on premature infants' brain activity (physical biomarker) and metabolic activity (biological biomarker).

NCT ID: NCT05835817 Recruiting - Premature Clinical Trials

Magnetoencephalography by Optical Pumping Magnetometer

MEG OPM
Start date: May 2023
Phase: N/A
Study type: Interventional

MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling. The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.

NCT ID: NCT05806684 Not yet recruiting - Premature Clinical Trials

Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.

biliROP
Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants. The main question it aims to answer are: • To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.

NCT ID: NCT05801640 Completed - Feeding Behavior Clinical Trials

Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

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

The aim of this study is to determine the effects of faciliated tucking and reiki given manually during orogastric tube insertion in preterm infants treated in the NICU on stress, pain and physiological parameter (heartbeat, blood pressure, SpO2 and respiratory rate) levels.