View clinical trials related to Premature Birth.
Filter by:This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.
Background: Admission to a Neonatal Intensive Care Unit (NICU) is associated with significant levels of parental stress and anxiety. Parents are often uncertain to perform care giving activities and might feel uncertain to fulfill the desirable parental role during NICU admission. Furthermore, transition of the NICU to another unit or hospital is stressful for parents often related to poor information and communication. A VOICE program is developed aiming to increase the empowerment of parents, to improve partnership between parents of very premature infants and healthcare professionals. Aim: To conduct a feasibility RCT study to evaluate the implementation and the effect of the VOICE program on parental stress and anxiety in the NICU. Methods: Design is a feasibility RCT to test the procedures, compliance, determine sample size, estimating recruitment and retention, and to get first insight in the effects of the VOICE program on the outcome measures. VOICE will be implemented as a structured empowerment and partnership program for parents from admission of the infant to the NICU till the first visit to the out-patient clinic. The program exists of five structured and focused meetings, following the acronym VOICE (Values, Opportunities, Integration, Control and Evaluation). These interdisciplinary meetings with parents aim to increase the involvement of parents in the care and decision making of participants' infant in the NICU. The primary outcome measures will be parental stress and anxiety measured by the Chinese version of the Hospital Anxiety and Depression scale (HADS) and the Edinburgh Postnatal Depression Scale (Chinese version). The secondary outcome measures will be parent satisfaction with care measured by the Empowerment of Parents in the Intensive Care (EMPATHIC-30) scale, length-of-stay in the NICU, hours of parental visitation and activities, compliance of NICU staff to the VOICE program. An embedded qualitative study will be designed to explore the experiences of parents and NICU staff about the implemented VOICE program. Individual interviews with parents and focus groups sessions with NICU staff will be conduction. This will help to identify methodological issues such as recruitment and retention and any enablers and barriers to the intervention which may impede the future RCT.
Inter-personal brain coupling between preterm infants, their parents and a musician during Creative Music Therapy using functional near-infrared imaging (fNIRI) hyperscanning and systemic physiology measurements
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality. However, there is few studies on this subject, especially concerning the neurodevelopment outcomes. Objective: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR. Hypothesis : Preterm infants with early and severe antenatal IUGR have more neurodevelopmental delay than infants with no IUGR.
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children. Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes). The researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.
This study will be conducted to evaluate the effect of grasping reflex stimulation applied during peripheral intravenous central catheter (PIC) intervention on pain and stress in preterm infants receiving treatment and care in the neonatal intensive care unit.
Premature birth (PTB, birth before 37 weeks of pregnancy) is a global, yet unsolved, problem. With a global amount of approximately 15 M babies born prematurely, PTB is the leading cause of perinatal morbidity and mortality in many countries. Furthermore, premature babies often have complicated medical problems, especially those born very early. Some women spontaneously deliver prematurely without any symptom or sign of the imminent labor, whereas others present with symptoms of preterm labor (PTL). In the latter case, clinicians can intervene and treat the woman with tocolytics and antenatal corticosteroids in order to accelerate fetal lung maturation and reduce the risk of respiratory distress syndrome. However, one of the major challenges in the management of women presenting with symptoms of PTL is to distinguish between true and false PTL with the existing clinical methods (digital examination or transvaginal cervical length assessment). In fact, over 50% of the women presenting with PTL symptoms do not deliver prematurely and are still unnecessarily hospitalized and treated with corticosteroids as well as tocolytics, and only less than 10% of women give birth within 7 days of presentation. Unnecessary treatments and hospitalizations also result in increased health costs. Thus, there is a need for more accurate methods and tools to evaluate the cervical maturation status as indication of imminent labor in order to avoid unnecessary hospital admissions and therapy. Recently, cervical stiffness has been evaluated as more reliable tool for prediction of spontaneous preterm birth. Cervical stiffness can be evaluated using ultrasound by cervical elastography , but also by an aspiration technique-based method with a novel CE-marked device, the Pregnolia System. Thus, the aims of this study are to evaluate: - if the cervical stiffness measured with the Pregnolia System can differentiate between women with true PTL and those with false PTL, - if the knowledge of cervical stiffness improves the detection of women at true risk of spontaneous preterm birth in combination or over state of the art (e.g. cervical length on TVUS).
This research investigates the impact of a hypnosis-based intervention in alleviating state anxiety in Preterm Premature Rupture of Membranes (PPROM). Our main hypothesis is that a two-session intervention can decrease anxiety for pregnant women with PPROM compared to usual care. This research also studies the impact of the experience of a PPROM during a pregnancy on several variables such as perinatal depression, pregnancy-related anxiety, bonding and childbirth experience, as well as control and pain perceived during chilbirth. Our hypotheses are that the experience of PPROM negatively influences these variables, and that this impact is alleviated by the hypnosis-based intervention for the experimental group.
Virtual reality application, which is a non-pharmacological method, is used for different purposes in many different fields. One of the areas where virtual reality application is used is health services. Its use in the field of obstetrics is new. Virtual reality application is often in pregnancy; it is used to reduce pain, stress and anxiety levels, exercise training and train pregnant women to effectively manage their pain during childbirth. Although pregnancy is a normal physiological process, adverse situations may occur that can make every pregnancy risky. Threatened premature birth, which is called the onset of uterine contractions without cervical changes between the 20th and 37th weeks of pregnancy, is also among these risk groups. Pregnant women diagnosed with the threat of premature birth are usually treated by hospitalization. Psychological problems such as stress, fear and anxiety may develop in pregnant women who are on bed rest in the hospital. In these pregnant women, mother-infant attachment may also be adversely affected. Pregnant women who are hospitalized and taken to bed rest due to risky pregnancy need to be informed and supported by health personnel. The midwife's spending enough time with the pregnant woman, keeping in touch and meeting her needs increase satisfaction in terms of care. When the literature was examined, it was determined that pregnant women were satisfied with the virtual reality application and thus increased care satisfaction.