33 Clinical Trials for Various Conditions
Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates. This study will compare the efficacy of a single dose of dexmedetomidine to controls.
This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training
The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.
The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the fathers, if present) of infants eligible for trials of the Neonatal Research Network (NRN) before they are approached for consent by clinical research coordinator (CRC) approach for NRN trial). Mothers will also be given a general information pamphlet addressing the same topic.
AHA and ACSM recognize lack of exercise is a major risk factor for developing cardiovascular disease (CVD), and other CVD risk factors such as obesity. It is important to note that CVD is the sixth leading cause of death and children are more likely to be undiagnosed due to their age and lack of symptoms. Further, according to the CDC, over one-third of children and adolescents are overweight or obese and at increased risk of CVD. Although many programs for children aim to decrease CVD risks and obesity few, if any, programs begin the intervention during prenatal development. Our preliminary findings suggest that regular maternal exercise improves cardiovascular health (lower heart rate, increased heart rate variability), normalizes body fat composition, and improves nervous system and motor tone even after birth. Norepinephrine is essential for fetal development, influences many tissues (heart, nerve cells, skeletal muscle, and fat cells), and can stimulate growth factors. It is believed that exercise hormones, such as norepinephrine, released during maternal exercise influence these growth factors during development. The central hypothesis of this proposal is that regular maternal exercise during pregnancy will improve the health of offspring before and after birth as evidenced by lower resting heart rate, increasing heart rate variability improved neurological maturation, and decreased adiposity. We have three specific aims to test this hypothesis through the Enhanced Neonatal Health and Neonatal Cardiovascular Efficiency Developmentally (ENHANCED) by Mom project (IRB approved #12-002524). Aim 1 will establish the association between maternal exercise during pregnancy and the heart health of offspring before and after birth. Aim 2 will determine the relationship between modes of regular maternal exercise and neonate neurological and muscular maturation as this relates to health of the child after birth. Aim 3 will elucidate the influence of different modes of maternal exercise during pregnancy on fetal and infant body composition as this relates to risk of obesity and CVD disease. These studies will provide novel insight into how different types of maternal exercise during pregnancy influence the overall health of offspring. Furthermore, these findings may have significant implications on the public health as it may provide evidence of pregnancy as the earliest intervention for attenuating cardiovascular disease risk of children.
Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
Enhanced Recovery After Surgery (ERAS) is a set of evidence-based guidelines that may be used during perioperative care for cesarean section. While there is good evidence that following ERAS protocols benefits postoperative recovery, less is understood about the effect on the fetus and neonate. This will be a randomized equivalence trial to determine if drinking a carbohydrate rich drink prior to cesarean section has an effect on neonatal glucose.
Women recruited from the internet will be put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information on the likelihood of survival and chance of disability for babies born at this gestational age. Participants will be randomized to receive this outcome data in one of three formats: as text-only, in a static pictograph, or in an iterative pictograph. Participants will also be randomized to seeing the chance of survival as 30% or 60%. Participants were then asked to choose between comfort care and intensive care in this situation. Participants' religiosity, value of the sanctity of life, and health literacy were also assessed.
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.
Women recruited from the internet were put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information in the form of pictographs about survival and disability of babies born at this gestational age. Participants were randomized to receive these pictographs in a different order (survival or disability first) and to receive descriptiveness level of survival (just numerical information, or also description of course of NICU stay). Participants were then asked to choose between comfort care and intensive care in this situation. Participants' religiosity, value of the sanctity of life, and health literacy were also assessed.
Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.
The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates.
This study will determine the feasibility of using auricular acupressure as an intervention in newborns with neonatal abstinence syndrome(NAS). Auricular acupuncture has been used as an intervention in adults in withdrawal by the National Acupuncture Detoxification Association with good results. The same points on the ear used by National Acupuncture Detoxification Association (NADA) will be used in this intervention using a spring-loaded microprobe to apply minimal pressure instead of needles. The purpose of this study is to identify barriers to recruiting newborns with NAS; to identify newborn behaviors during the intervention that determine tolerance of the intervention, and to compare results of vitals signs and withdrawal scores prior to intervention and post-intervention.
Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs choose to store these specimens for several uses including biomedical research. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinical setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during postpartum clinical care, will be recruited and randomized to one of three groups. Specific Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing hospitals and Department of Community Health staff before and after the intervention. * Hypothesis 1) Women in the Interactive technology group (Group A) and the video group (Group B) will demonstrate higher knowledge at Time 1 and Time 2 about the consent elements and the BioTrust than those who do not receive either EICI tool (Group C). * Hypothesis 2) Women in the EICI groups (Groups A and B) will demonstrate lower decisional conflict at Time 1 and Time 2 toward biobanking than those who do not receive the EICI (Group C). * Hypothesis 3) Women in the EICI groups (Groups A and B) will not differ significantly in their choices about biobanking and attitudes toward NBS and biobank research compared to participants who do not receive EICI tool (Group C).
Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The prior HEAT study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating room temperature. The investigator's objective is to determine if an increase in ambient operative room temperature decreases the rate of neonatal morbidity. Operating room temperature will be randomized to the current institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for a period of 1.2 years.
Alterations in the intrauterine environment can have profound effects on fetal development. Diabetes during gestation results in multiple deleterious short-term outcome differences, and is correlated with long-term developmental deficits. Multiple studies, in neonates through school-aged children, have demonstrated differences in language, attention and psychomotor development in offspring of diabetic pregnancies. Neonatal EEG is a promising and non-invasive tool for assessment of abnormal brain development or "dysmaturity" in this population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters change predictably with advancing gestational development and have been used to differentiate between at risk groups in neonatal studies. The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain development. The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and 5 days of life during birth hospitalization. Additional data will be extracted from maternal and neonatal medical records and a maternal questionnaire. In addition to evaluating the measures of cEEG and aEEG, this project will establish a research cohort. A subsequent study involving developmental evaluations will allow for correlation of EEG results with long-term outcomes. The ability to identify those at risk at birth would provide the opportunity to intervene in order to mitigate outcome differences, particularly in language development. More significantly, we hope to establish neonatal CNS outcome measures for future diabetic pregnancy intervention studies. .
Regular maternal physical activity leads to the delivery of lighter, leaner infants. Higher birth weights and childhood obesity are both strong predictors for adult obesity, suggesting that the impact of maternal physical activity on the future health of a child is substantial. However, the mechanisms underlying the relationships between maternal physical activity and improved infant outcomes are unclear. Thus, the purpose of this project is to measure two potential contributing factors: maternal fat metabolism and maternal oxidative stress profiles. The investigators believe that maternal physical activity leads to beneficial alterations in maternal fat metabolism and oxidative stress profiles. Further, the investigators believe that both maternal fat metabolism and oxidative stress levels are related to infant outcomes such as obesity and insulin resistance. Therefore, exercise will improve maternal metabolic factors that can lead to improvements in infant outcomes. The investigators will compare these factors between obese inactive pregnant women and obese active pregnant women. This study design will allow us not only to determine the effect of physical activity on maternal and neonatal pregnancy outcomes, but also to establish whether obesity or physical inactivity should be a primary area of focus when prescribing pregnancy interventions in clinical practice.
Prematurity is a very important problem in this country. Prematurity can cause problems with organ (such as the brain, heart, kidneys) growth and development. A very important part of keeping premature babies healthy is ensuring good blood flow to all of these organs. Some premature babies have problems with their hearts and getting enough blood out to the rest of their bodies. This problem is referred to as hypotension (low blood pressure) and is found by looking at blood test values and while examining the baby. These babies will need medications to help their heart deliver blood to all of the important areas in their bodies. Babies who have hypotension requiring medications tend to have more problems than premature babies that don't need hypotension medication. Some of these problems include a higher risk of bleeding into their brain, kidney problems, liver problems, intestinal (gut) problems causing difficulty tolerating feeds, and a very dangerous infection of their intestines. Some long term effects include hearing loss, developmental delay, and learning problems in the future that are worse than other premature babies who did not have hypotension. Hypotensive premature babies also have a higher risk of death. The cause of hypotension in the first week of life is still not known. We know that babies have to get used to being in the outside world instead of in the womb. A lot of changes with the heart and lungs have to happen for them to not be affected by that transition. If we could gain a better understanding of those changes, we might be able to prevent some of these issues from happening. This study will look closely at premature babies with and without hypotension to assess the heart and lung changes in the first week of life. To do this, we will use monitoring machines and tests to get a better idea of all the changes that happen. This information will help all neonatologists who care for premature babies.
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.
The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.
This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of \<1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the hypothesis that children who were exposed to cancer or cancer treatment (cytotoxic drugs, radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic examination).
The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.