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Newborn clinical trials

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NCT ID: NCT05442619 Completed - Pain Clinical Trials

Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection

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

The neonatal period covers the first 28 days after birth. Newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting in this process, and for these reasons, children are brought to the emergency services. From the moment they enter the emergency service, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural methods of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management in newborns. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. While it has been reported in the literature that there are non-pharmacological methods including individualized developmental care practices in the procedural pain management of newborns; there are no studies aimed at reducing their pain, preventing their exposure to environmental factors and ensuring their comfort during painful procedures in pediatric emergency departments. In this context, it is planned to use a portable therapeutic baby nest in the pediatric emergency department, where newborns will feel safe and maintain their flexion posture during the venous blood sampling, as well as be protected from noise and light, thereby reducing the pain caused by the procedural method and providing comfort, and a randomized controlled experimental study.

NCT ID: NCT05248477 Recruiting - Newborn Clinical Trials

Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)

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

The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery. Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery. The follow-up collected for this study will take place: - At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents - At the child's discharge from the hospital, or if he or she dies in the hospital: - Collection of clinical data (principal endpoint) from data in the medical file. - Data to measure practices and adherence to the intervention will be collected - When the child reaches the corrected age of 2 years: - a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness.. - Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, the ASQ (Ages and Stages Questionnaire), which the parents will complete.

NCT ID: NCT05109481 Not yet recruiting - Newborn Clinical Trials

Masks and Visual Preferences in the Newborn

BABYMASK
Start date: November 15, 2021
Phase:
Study type: Observational

What impact can facial masks have on face exploration in the first few weeks of life? No study has yet investigated this. The objective of our study was to evaluate the impact of the mask on the face processing (preferential gaze, visual recognition) of the term infant for familiar (e.g. mother's face) and unfamiliar (stranger's face) faces. This is a prospective study which will take place in Grenoble Maternity Hospital. 200 newborns will be enrolled between 24 hours and 7 days of life during one year. Different pairs of images will be presented on a screen while an experimenter records the infant's gaze. On each trial, the experimenter will judge when the infant is looking at the screen or not and assess when 10 seconds of screen gaze time has been accumulated. The comparisons will be made to determine whether statistically, one face is looked at significantly longer than another.

NCT ID: NCT05103800 Completed - Pain, Acute Clinical Trials

Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns

IEWNLPCDIIN
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

Comfort, distress and the absence of pain can be described as free from anxiety, somewhat enjoyable and ease (peaceful) situation. The child health and disease nurse should come up with physiological problems of the baby, increase the comfort degree to reduce the stress level of the baby and ensure improvement in the baby's location. This research was experimentally designed to investigate the effect of the baby's own intrauterine heart sound on pain and comfort during the invasive procedures applied to the healthy born babies in the delivery units of the Batman Gynecology and Pediatrics Hospital. The research will be performed by selecting samples in a simple random sampling method from the babies who born healthy and timely in the normal vaginal way. The number of samples will be determined by power analysis method after pilot study. The previously white noise will have listened to the babies in experimental group and will be recorded by camera during invasive interventions and the pain and comfort scale will be applied. The scales will be applied to the control group let them without listening White noise but also will be recorded with camera and thus the data will be collected. A nurse working in the unit will perform invasive interventions, later two specialists will watch video records and so the pain and comfort scales will be filled. No study on this subject was found in the international literature review. Based on the need to fill this gap in the literature, it seems that the study will contribute to the field of child health and diseases nursing.

NCT ID: NCT05077345 Completed - Pain Clinical Trials

The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit

PAIN
Start date: January 15, 2019
Phase:
Study type: Observational [Patient Registry]

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. It has been reported that newborns born between the gestational ages (GY) 25-42 and hospitalized in the NICU undergo an average of 14 painful procedures per day in the first 2 weeks of life. The aim of this study is determinin the effect of different procedures on the pain levels of newborns in the Neonatal Intensive Care Unit (NICU).

NCT ID: NCT05064683 Completed - Newborn Clinical Trials

The Effect of Facilitated Tucking and White Noise on Stress and Sleep of Newborns in Nasal CPAP

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

Purpose: Newborns go through biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life due to various reasons. For newborns whose systems are still immature, leaving the warm, dark, quiet, calm, fluid-filled mother's womb and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake order necessary for brain development and maturation. Newborns have extensive sleep requirements for the development of their neurosensory system. It is known that the brain activity of newborns in the intrauterine period is similar to the REM (Rapid Eye Movement) sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period.Therefore, sleep quality in the newborn period is directly related to healthy development.In this direction, our research was carried out to examine the effects of fetal position and white noise on stress and sleep in newborns with nasal CPAP(Continuous Positive Airway Pressure). Design and Methods: . This randomized experimental study was conducted on 108 newborns at the gestational week of 26 or higher in the newborn intensive care unit of a university hospital. The researcher applied white noise (n:36), and facilitated tucking(n:36) to the newborns. The control group (n: 36) received no intervention except for the routine clinical practices. Facilitated tucking white noise interventions were applied to the newborns included in study for 24 hours, their stress levels were monitored with the neonatal stress scale, and their sleep durations were monitored with a sleep-wakefulness measurement device and recorded in the newborn follow-up form. Statistical analysis was performed using percentages, means, and ANOVA test.

NCT ID: NCT04934254 Enrolling by invitation - Newborn Clinical Trials

THE NEWBORN SKIN ASSESSMENT ATTITUDE SCALE

Start date: March 30, 2021
Phase:
Study type: Observational

The protection of the body integrity of the newborn is very important in terms of the development of physical and mental health and social health. Failure to protect the skin integrity of newborns and not paying attention to the clinical findings on the skin may cause morbidity/mortality. Attitudes of nurses can affect the evaluation of newborn skin negatively and/or positively. It was determined as the development of an attitude scale for newborn nurses to evaluate newborn skin and examining the factors affecting their attitudes. In line with this purpose, an attitude scale for newborn nurses regarding the evaluation of newborn skin will be developed and nurses' attitude levels, sociodemographic variables that are related to attitude and cause significant difference can be determined.

NCT ID: NCT04905537 Recruiting - Newborn Clinical Trials

Study on Early Genetic Screening and Precise Strategy of Neonatal Critical Illness

Start date: January 1, 2021
Phase:
Study type: Observational

The researchers hope to establish an overall program of early genetic screening for neonatal critical illness in China, and to develop precise intervention strategies to assist clinical diagnosis and treatment of hereditary critical illness.

NCT ID: NCT04869176 Completed - Clinical trials for Heart Rate Variability

Effect of Caffeine on Heart Rate Variability in Newborns

Start date: November 17, 2017
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the impact of caffeine treatment, given either orally or intravenously, on heart rate variability in newborns. In addition, the investigators sought for a potential association between caffeine treatment and vital functions.

NCT ID: NCT04827849 Completed - Nursing Caries Clinical Trials

Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby

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

A randomised control trial will made to determine the effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant