View clinical trials related to Premature Birth.
Filter by:The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices. This study consists of two stages. In the first stage, it is planned to develop a scale to determine the self-efficacy levels of mothers of premature babies based on individualized developmental care. In the second stage, the scale will be applied. At this stage, families will be trained for individualized developmental care and the effectiveness of the education will be evaluated through the developed scale. For the first stage of the study, it is stated in the literature that at least 5 times the number of items should be taken in determining the sample size during the scale development stage, and 10 times in order to increase the reliability of the scale. In this study, after creating the scale items, a pilot application will be made with 3 mothers. Feedback will be received from mothers regarding the clarity of the questions and the scale will be finalized according to the feedback received. Then, the scale will be applied to the participant with a size of at least 10 times the number of scale items. For the second phase of the study, firstly, a preliminary application will be made with 10 mothers who meet the inclusion criteria and agree to participate in the study. The number of samples to be taken for the second stage of the research will be determined by performing power analysis with the findings obtained. Mothers included in the preliminary application will not be included in the study. It is planned to use stratified block randomization method in the study. First, mothers will be stratified according to their education level and the total number of children they have, then an equal number of (blocking) mothers will be assigned to each group. Data will be collected after obtaining written permission from the institution where the research will be conducted. "Descriptive Information Form", "Informed Voluntary Consent Form" prepared by the researchers and "Individualized Developmental Care Based Premature Baby Mothers' Self-Efficacy Scale" will be used in data collection.
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).
This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach. The main question it aims to answer are: - Develop a model that can predict the occurrence of AKI in infants admitted to the NICU; - Identify the drug or combination of drugs associated with an increased risk of AKI. The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.
The aim of this study is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. As a result of the power analysis using the G Power 3.0.10 program, 90% power; A total of at least 78 samples were found to be sufficient in the study with a 5% margin of error (n1: 39; n2: 39). However, considering that the case could be lost, it was decided to increase it by 20% to 94 babies. Infants will be assigned to groups using a stratified sequential block randomization method. Premature babies will be stratified by week of gestation, birth weight and sex, and then an equal number of babies will be assigned to each group by blocking. The appointment of premature infants will be decided by sequential block randomization. After the descriptive information of the babies assigned to the groups is recorded in the questionnaire, the experimental group will be fed by applying the chronobiological nutrition approach. The control group will be fed without applying the chronobiological nutrition approach. The discharge times will be calculated for both groups.
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants and their parents. Skin-to-skin contact provides hemodynamic and thermal stability in preterm infants. Regarding parents, skin-to-skin contact sustains the parental bonding, and reduces stress and anxiety related to hospitalization. As a result, early skin-to-skin contact has been associated with an improvement of neurological outcome in very preterm infants. Thermal stability is crucial during the first hour of life in preterm infants. A temperature at admission in the neonatal intensive care unit below 36.5°C or above 37.2°C has been associated with an increase in neonatal morbidity and mortality. Early skin-to-skin contact between a newborn and his/her mother in the delivery room significantly decreases the occurrence of hypothermia below 35.5°C. The practice of skin-to-skin transfer from the delivery room is emerging in France. Pilot studies have been carried out by French neonatal teams that showed the feasibility of this practice in late-preterm, near-term and term infants. Although skin-to-skin contact routinely involves very preterm infants in neonatal intensive care units worldwide, the feasibility and safety of skin-to-skin contact during the transfer from delivery room to the neonatal unit is poorly documented in very preterm infants. Previous data of our team showed that transfer of preterm infants with non-invasive ventilation using skin-to-skin contact was feasible and safe but concerns emerged about the thermal conservation during the procedure. The main hypothesis of this study is that skin-to skin contact during the transfer from the delivery room to the neonatal intensive care unit could prevent heat losses in preterm infants as well as the transfer in incubator. Another hypothesis is that very early skin-to-skin contact could positively influence the neonatal course and the parental experience in the neonatal care unit.
The preferences to masked and unmasked faces is relevant for premature newborns, since Covid-19, most of the faces that surround them during their hospitalization are masked. The Premask project is a continuation of the InfantMask and BabyMask studies (concerning infant and newborn), by studying the visual preferences to masked and unmasked faces of premature newborns.
To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment
The main objective of the study is to demonstrate that prophylactic treatment of patients with asymptomatic frequent (>10%) PVCs is superior to simple follow-up strategy with no therapy to prevent subsequent LV dysfunction at 24 months. The prophylactic treatment is based on drugs ± ablation (ablation can be performed if the PVC burden remain >10% after 2 lines of AAD treatment since the initiation of the study). The primary endpoint will be the development of LV dysfunction (PVC-iCMP) defined as a 15% relative LVEF decrease (and/or a LVEF <50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).
Project Summary: The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally. These infants with an immature immune system and gastrointestinal tract are at risk of complications of premature birth, which is the leading cause of neonatal death. According to researcher hypothesis for this study, there is role of probiotics in promoting food tolerance and reducing the incidence and severity of Necrotizing Enterocolitis (NEC) and death related to NEC in pre-term VLBW infants. In the current study, we will examine the effects of probiotics in premature infants and figure out the optimal intervention through randomized controlled trial (RCT). A prospective, masked, randomized single blinded controlled trial will be conducted in the neonatal intensive care unit (NICU) of Services Hospital Lahore. In this trial the treatment group will receive the probiotics during their first month of life, and the control group will receive no treatment. Primary outcome will be the incidence of death or NEC (≥ stage 2). Death is included as a primary outcome because it is a competing variable of NEC. The x2 test will be used to analyze the categorical data, along with Fisher's exact test when applicable. The Student's t test will be used for continuous data. A logistic regression model will be used to analyze the treatment effects on the primary and secondary outcome variables (death, NEC, and sepsis). Values will be expressed for mean and standard deviation. Statistical significance is set at P-value of 0.05. The objective of this study is to confirm the evidence and to get the more reliable and authentic results regarding the more effective treatment of NEC in preterm neonates. In this way, the researcher shall be able to improve the outcome of premature births and to reduce the complications by increasing the cure rate. Similarly, it will help the researcher to improve knowledge for better management of NEC in neonates.
Retinal vascularization in humans develops between the 16th and 36th week of amenorrhea, centrifugally from the papilla. In case of premature birth, the immature retinal periphery is at risk of ischemic damage due to lack of vascular development. Prematurity is often associated with respiratory fragility. It often requires ventilatory assistance in the form of oxygen therapy, invasive (oro-tracheal intubation) or non-invasive, which leads to reflex arteriolar vasoconstriction aggravating the ischemia already present. One may wonder if there are subclinical retinal vascular changes, detectable on Tomographie par Cohérence Optique-Angiography (, that could explain the greater risk of amblyopia and optical correction observed. Tomographie par Cohérence Optique-Angiography is a fast growing technique in retinal vascular pathologies: it is a simple, fast, reliable, non-invasive, injection-free examination, which allows to study in high resolution the retinal vascularization, with a distinct analysis of the retinal plexuses and the choriocapillaris