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Newborn clinical trials

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NCT ID: NCT06032494 Recruiting - Newborn Clinical Trials

Investigating Changes in Vital Signs in Neonates

Neo-vital
Start date: September 20, 2023
Phase:
Study type: Observational

1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care. Many factors lead to changes in vital signs, for example, medical procedures such as blood tests can result in brief increases in heart rate. Medication can also alter vital signs, either as an intended effect or as a side effect. However, different infants will respond in different ways to both procedures and medication. Predicting how an individual infant may respond could lead to better individualised care for infants. For example, using an infant's baseline vital signs to predict whether they will experience cardiorespiratory side effects from a particular drug could mean that doctors could choose an alternative safer treatment plan. To develop these predictive models, it is essential to first better understand how infants' vital signs are affected by different procedures and drugs, and how these effects are impacted by other factors such as infection, other pathologies, interaction between drugs and age. Despite their routine use in hospital neonatal units, detailed electronic records of vital signs are often not recorded. Often, only major events or average values are stated on clinical records. Subtle changes in vital signs are therefore missed, and more complex analysis that may reveal important predictive features within the data is not possible. In this study the investigators will electronically record infant vital signs across longer time periods and during a variety of clinically-necessary procedures and administration of drugs, to explore how these impact vital signs and are altered by factors such as age and pathology. These will be compared with control procedures, such as a nappy change, or when the infant is resting in their cot or receiving skin-to-skin care.

NCT ID: NCT05967572 Recruiting - Clinical trials for Retinopathy of Prematurity

The Effect of Different Music Listened During Retinopathy Examination to Premature Infants

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

Retinopathy of Prematurity (ROP); It is a disease of premature and low birth weight infants, characterized by incomplete vascularization of the retina, etiology and pathogenesis of which is unknown, and causes vision loss. There is an increase in the incidence and severity of ROP development in direct proportion to the decrease in birth week and birth weight. While ROP is a problem below 32 weeks of gestation in developed countries, it is reported to develop severely up to 34 weeks of gestation in developing countries. In a multicenter study conducted by the Turkish Neonatology Society in our country, the frequency of ROP in very low birth weight preterm infants was found to be 42%, and the frequency of advanced ROP was 11%. The incidence of ROP in babies with a gestational age of 33-35 weeks was 6.1%, and advanced ROP was 6 per thousand. The frequency of ROP was found to be 10.3% in babies with a birth weight of 1500-2000 grams, and severe ROP was reported in 19 of these babies. ROP examination is a procedure that causes pain, deterioration in comfort and physiological changes in preterm newborns. After this examination, an increase in blood pressure and heart rate and a decrease in oxygen saturation are observed. Pharmacological and non-pharmacological (non-pharmacological) methods are used to reduce the pain and increase the comfort level of the premature newborn. As a pharmacological method, there is no other routine method used to reduce pain other than the administration of local anesthetic drops before the examination. Because of this situation, nurses apply various non-pharmacological methods to alleviate pain. These methods are; breast milk, sucrose use, oral dextrose use, non-nutritive sucking, positioning, listening to music and mother's voice. In the literature, no specific study was found in which music was used to reduce pain and increase the comfort level during the ROP examination. Therefore, this research will be carried out to determine the effect of different music played on the pain and comfort level of premature babies during the retinopathy examination.

NCT ID: NCT05805241 Recruiting - Newborn Clinical Trials

Pharmacogenetics Analysis of Fentanyl Administered in Newborns

Start date: February 7, 2023
Phase:
Study type: Observational

Fentanyl is an opioid drug used as analgesic and anaesthetic also in Neonatal Intensive Care Units (NICU), according to the last national and international recommendations, during invasive life support strategies such as mechanical ventilation. Opioids manifest their sedative effect through activation of μ-opioid receptors, which are abundant both in the central and peripheral nervous system. Comparing fentanyl to morphine we can appreciate a much more powerful effect (75-220 major) with lower doses to obtain similar analgesic effect; these characteristics are due to the high lipophilicity of the molecule which easily crosses the blood-brain barrier (BBB). At the same time, fentanyl shows less adverse effects than morphine such as vomiting, nausea, gastrointestinal constipation, respiratory depression, dependence and tolerance. The drug is extensively metabolized by liver enzymes. In routinary clinical practice it has been observed that large interindividual differences are found in the daily dosages needed to achieve pain control. Literature evidences that pharmacodynamic variation related to genotypes in receptor signalling or pain modulators may play an important role in this variability. Many genes are related to fentanyl pharmacodynamics and pharmacokinetics. Some polymorphism in these genes are already known to correlate with toxicity or efficacy of the drug, also in the paediatric population. More polymorphisms could be involved in abnormal pharmacodynamic or pharmacokinetics of fentanyl, therefore studies are necessary to better explain the possible role of pharmacogenetics in precision medicine especially in a very specific population as newborn.

NCT ID: NCT05789836 Enrolling by invitation - Nursing Caries Clinical Trials

The Effect of Partıcıpatıon in Care of Mothers

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

The aim of the study is to examine the effect of including mothers with newborn babies in surgical intensive care units during the nursing care process on mother's self-confidence and mother-infant attachment.

NCT ID: NCT05776615 Active, not recruiting - Nursing Caries Clinical Trials

The Effect of the Mobile Application Developed for the Care of Sick Newborns

Start date: July 24, 2023
Phase: N/A
Study type: Interventional

The goal of this randomize controlled trial determine the effect of the mobile application developed for the care of sick newborns in the Neonatal Intensive Care Unit on nurses' perception of nursing diagnoses and care that cannot be met, and to measure the usability of the mobile application. The main questions it aims to answer are; Does the mobile application developed for the care provided in the neonatal intensive care unit have an effect on the perception of nursing diagnoses? Does the mobile application developed for care provided in the neonatal intensive care unit have an impact on "missed nursing care? Participants will be used for 3 months from the developed mobile application. The control group will continue routine nursing care. Researchers will compare the perception of nursing diagnosis and unaffordable nursing care survey at the end of month 1 and month 3. Additionally, the usability of the mobile application will be evaluated by applying the system applicability scale to the experimental group.

NCT ID: NCT05775692 Recruiting - Infection Clinical Trials

Population Pharmacokinetics of Fluconazole in the Treatment of Neonatal Fungal Infectious Disease

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

This study is based on the hypothesis that the pharmacokinetics of fluconazole in newborns and children are different from adults. We aim to study the population pharmacokinetics of newborns and children receiving the fluconazole for treatment of infectious diseases. In this study, we will detect fluconazole concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of fluconazole with treatment effectiveness and incidence of adverse effects in newborns and children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in newborns and children. It will also set the foundation for further studies to improve fluconazole therapies for newborns and children.

NCT ID: NCT05729698 Completed - Preterm Birth Clinical Trials

Efficacy of A Novel in Prevention of Neonatal Hypothermia

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia. Design: Randomized controlled clinical trial Setting: The research was carried out in the NICU of a training and research hospital in Istanbul. Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).

NCT ID: NCT05694390 Completed - Newborn Clinical Trials

The Effect of the Use of Sterile Transparent Film Dressing in Newborns

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

It is important that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. The aim of this study was to determine the effect of sterile transparent film dressing and tape methods used in pe- ripheral intravenous catheter application in newborns on the duration of catheter stay and the development of catheter-related complications.

NCT ID: NCT05524337 Recruiting - Pain, Acute Clinical Trials

White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance

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

This randomized controlled study was planned to evaluate the effects of listening to white noise and therapeutic touch on physiological parameters, pain and comfort level during the heel blood collection procedure on infants who gave birth at 32 weeks and above and were given to their mothers in Atatürk Training and Research Hospital.

NCT ID: NCT05448508 Completed - Pain Clinical Trials

The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection

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

Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets. In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.