Active clinical trials for "Premature Birth"

This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion. The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below: Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups. Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups. Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups. Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups. Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.

This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.

The objective of this study is to determine the extent to which the SMART NICU2HOME (including EMR interface) and the NICU2HOME apps, mobile applications designed for parents of premature infants to receive daily, real-time information about their infants and personalized education material based on parents' anticipated concerns and their infant's clinical status, is effective in: 1) improving parents' competency in caring for their sick infants, 2) reducing stress, 3) supporting parents' social supports and 3) improving NICU outcomes (parent satisfaction, length of stay, readmission rates.)

Background (brief): Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn mortality (28 per 1000 live births). In 2010, prematurity represented ~14% of all births and directly and indirectly contributed to 45% of all neonatal deaths. Gestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported information, recommended by the World Health Organization for estimating gestational age but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP. Relevance: The goal of this study is to improve maternal and newborn outcomes by increasing the accuracy of gestational age estimation, using menstrual based dating, that is vital for providing timely and necessary obstetric and newborn care interventions. The study will determine the efficacy of three community based interventions using e-platform targeted to improve the recall and reporting of the date of last menstrual period in a rural resource poor setting. The innovative e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where e-Health and m-Health initiatives are proliferating with active support from all sectors in policy and implementation. Hypothesis : Implementation of conventional and e-platform based interventions will lead to a 30% improvement in recall of the date of the LMP in adolescent girls and married women in rural Bangladesh. Intervention triggered improvement in LMP date recall among pregnant women in rural Bangladesh will improve the accuracy in GA estimation. Objectives: The main objectives of the study are to: Determine whether a set of conventional and e-platform based interventions improve recall of the date of the LMP in adolescent girls and married women in rural Bangladesh. Determine whether intervention triggered improvement in LMP date recall in rural Bangladesh improves the accuracy in GA estimation or not Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three conventional and e-platform based interventions is proposed to improve recall of GA with a control arm. The trial will be conducted among adolescent girls and recently married women (within past two years) with no children or a single child in Mirzapur sub-district of Bangladesh.The interventions include (i) education and calendar for recording date of LMP (ii) education and SMS based system for recording dates of LMP and reminders using mobile phone (normal) (iii) education and smart-phone based application for recording dates of LMP with an inbuilt reminder system. Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall of LMP date among enrolled participants in the three different intervention compared to control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared to USG, following the intervention.

In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care. We simultaneously identify the degree of implementation success and the contextual factors associated with success across 6 antenatal clinics in Blantyre District, Malawi. If results are negative, governments will avoid spending on ineffective care. Positive maternal, neonatal and HIV-related outcomes of group antenatal care will save lives, impact the cost and quality of antenatal care, and influence health policy as governments adopt this innovative model of care nationally.

As a result of technological advances in the field of newborns, the survival rates of very young babies have increased. With this situation, there was a need to develop new evidence-based application areas in premature babies. Nurses provide evidence-based care in many areas to term and preterm babies in the neonatal intensive care unit. One of these areas is the skin, which is known as 13% of the newborn's body weight and constitutes the largest part of the organism. Before skin care is given, knowing the skin characteristics of the newborn and performing skin care in accordance with these features will provide more benefits for the baby. The skin of newborns is different from adults in terms of both function and function. In addition, skin characteristics of term and preterm babies also differ according to the week of delivery. Skin basically enables the newborn to explore the world by thermoregulation, as a barrier against microorganisms and chemical harmful substances, maintaining fluid-electrolyte balance, vitamin D production, fat storage and sensory-touch. The immature skin of the newborn cannot fully fulfill these functions. In another study conducted between sunflower oil and the control group, it was stated that rash and peeling were less common in the sunflower oil experiment group compared to the control group. As a result, evidence-based knowledge of nurses about neonatal skin care should be increased in neonatal intensive care units, and appropriate nursing care should be given especially to premature newborns who are at risk due to hospitalization. Even if there is no routine procedure in our service, baby oil is massaged during care hours, but there is no study on this. The aim of this study is to contribute to the neonatal skin care literature and to provide appropriate evidence-based care in the service routine.

The purpose of this project is to provide a stepwise, methodical approach to developing and testing the ability of NICU2HOME+ to support diverse Illinois families of premature infants during and after their NICU stays in an effort to address health equity, improve parenting, and reduce costs. There are 3 objectives of the study: 1) Identify and assess the requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement applications with EMR integration that is culturally appropriate and customized to the needs of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2) develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective in: a) addressing health equity issues, b) improving parenting self-efficacy and satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower readmission rates that result in lower healthcare costs. All research recruitment and participation will take place in the following spaces: Northwestern Medicine's Central Dupage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices

This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants. This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.

The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside. The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The investigators will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention. The investigators also predict that the infant's vital signs will remain stable and/or improve when the recording is played.

This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of development. This active intervention, starting at either 2 or 4 months of age (depending on randomisation), could be more effective than waiting until a problem is detected before giving glasses. As this is a feasibility study, the investigators are looking at a small sample of babies (n=75) to see whether their parents/carers are willing to take part in a 3-arm study comparing two differently timed interventions to a control group, as well as looking at different aspects of the research plan in preparation for a larger final study.