View clinical trials related to Premature Birth.
Filter by:In the study, selections to the experimental and control groups will be made randomly and simple randomization method will be used. In this context, the individuals included in the research will be assigned to the control and initiative groups respectively and randomized by an expert statistician.The sample of the study was found to be at the 95% confidence interval and at the level of α= 0.05. The effect size was found to be 0.5703 based on previous studies. With a theoretical power of 0.95, the minimum sample size was totally calculated as 51, 17 for the intervention 1 (back massage), 17 for the intervention 2 (breast massage) group and 17 for the control group. However, it was aimed to reach 60 people by predicting that there might be case losses, and it was planned to recruit 20 people for each group. The dependent variables of the study are the amount of breast milk and the level of anxiety. The independent variable is the back and breast massage practice. This research will be carried out in Zonguldak Gynecology and Pediatrics Hospital between 1st July 2021-2022.
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.
Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously. Study objectives include: 1. Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU. 2. Assess safety of using a special wireless sensor system in neonates. 3. Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood. It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass. It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood. Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol. Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed. The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited. The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.
This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research. The proposed study has six specific aims: 1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home. 2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home. 3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home. 4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home. 5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home. 6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
The purpose of this study is to assess knowledge about emotional connection, attitude about relational health, and efficacy of Welch Emotional Connection Screen (WECS) training in the NICU. The investigators seek to discern if through this didactic training, frontline NICU clinicians can be taught to reliably use the WECS to rate parent-child relational health. Additionally, the investigators seek to learn if there is construct and theoretical validity of the hospitalized infant preterm WECS by correlating WECS scores to physiological, behavioral and mental health markers for parent and infant.
Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin holding (SSH) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSH; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSH; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff. The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 3 continuous weeks is proposed. 20 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 3 continuous weeks, or to 3 weeks of standard NICU care. Research questions: Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 3-week treatment period, and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT? Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 3-weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signaling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during 2 resting/sleeping state and routine diaper change sessions (baseline and post 3-weeks of daily Calmer exposure)?
This randomized control trial is designed to explore the effect of low-level tragus stimulation in patients with frequent premature ventricular contractions.