View clinical trials related to Neonatal.
Filter by:Background: Even the healthiest infants undergo painful procedures as part of universal medical care. Untreated early pain is associated with heightened pain response during later procedures in infancy and alteration in response to pain in childhood. Oral sucrose is currently considered the standard of care for acute pain relief in infants. Compelling evidence from 57 randomized controlled trials suggests that oral sucrose reduces bio-behavioral pain response. However, recent data examining the influence of oral sucrose on pain-specific brain activity measured using electroencephalogram (EEG) questions the efficacy of this intervention for reducing pain in the infant brain. Evidence supports the effectiveness of breastfeeding as a pain relieving intervention, however, no studies to date have examined the effect of breastfeeding on pain-specific activity in the newborn brain. Aims: The primary aim of this study is to examine the influence of breastfeeding in comparison to oral sucrose on pain-specific activity in the newborn brain during a heel lance. The secondary aim will be to determine if there is convergence among outcome measures in either of the intervention conditions. Methods: Utilizing a single blind, randomized controlled trial design, 126 healthy term infants will be recruited within the first two days of life. Infants will be randomized to have a medically indicated heel lance completed in one of two possible conditions: 1) breastfeeding (n = 63) or 2) sucrose in an infant cot (n = 63). Infants will not be eligible for study participation if they show signs of lower limb tissue damage, have had previous surgery or intraventricular hemorrhage, are born to opioid using mothers or with significant genetic disorders, are unable to breastfeed, or have contraindications to sucrose administration. Pain-specific brain activity will be recorded on EEG for the duration of the blood collection. Infant facial response will be video recorded, and heart rate and oxygen saturation will be measured for calculation of Premature Infant Pain Profile-Revised (PIPP-R) Score, a reliable and valid bio-behavioral measure of pain in infants' 26-44 weeks gestational age. For infants randomized to the breastfeeding condition, data collection will begin with recording of a one-minute baseline (BL1). Following this, a non-painful control stimulus will be applied to the infant's foot to capture a baseline response on EEG to a non-painful event. The infant will then be transferred to the mother and active breastfeeding will be facilitated. A second baseline (BL2) will be recorded prior to heel lance. Pain response will be recorded from the initiation of the heel lance until procedure completion. In the sucrose condition, all monitoring will take place while the infant is in a cot (considered standard of care). Procedures will be consistent with those outlined above with the exception of administration of 24% oral sucrose two minutes prior to the heel lance. Analysis and inference will be calculated based on the intention-to-treat principle. Data from the EEG recording will be grouped into basic waveforms using principal component analysis. Two one-way analysis of variances will be used to assess the effect of stimulation type (non-painful control, painful heel lance) and treatment (24% oral sucrose, breastfeeding) on the principal components. To assess for the effect of treatment on PIPP-R score, group means will be compared using unpaired Student's t-tests. Hypotheses: Infants in the breastfeeding condition will demonstrate both lower pain-specific brain response and lower bio-behavioral pain scores than infants in the sucrose condition. Significance: This will be the first study to examine the effect of breastfeeding on pain-specific brain response in infants. In light of the negative consequences of unmanaged pain in infants, it is imperative that effective pain relieving interventions are utilized. Given recent evidence questioning the analgesic properties of sucrose, findings will have important implications for informing optimal pain management practices in infants.
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
The purpose of this study is to explore the quantity of excipient exposure in neonatal and young pediatric patients in a Danish Hospital. The focus will be on the preservatives ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame, glycerol and sorbitol.
The immediate newborn period is the period of highest morbidity in life. Early signs of serious disease are often vague and difficult to interpret for the non- specialist. Screening lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover only one or two diseases, and are complicated to handle in low resource settings. In critically ill newborns, organ failure to one or multiple organ systems is frequently seen due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of the cells in the affected organs followed by energy deficiency. Independently of the condition causing the energy deficiency this will start a series of events, which initially cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns suggests that LDH is a clinically interesting early predictor of serious illness and may thus serve as an important complement to the clinical examination. If the LDH level is elevated the health care personnel will realize that something is wrong and call for appropriate measures. Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and accurate method. However, this method needs relatively large blood volumes and the delay between blood sampling and results is rather long, often several hours. In addition LDH is sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is detected at the laboratory a new sample will be needed, thus delaying the result even more. Also, smaller health care facilities rarely have the laboratory equipment needed for the analysis of LDH. The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH analysis called "Hilda Neo". LDH is analyzed on an easy-to-use consumable test card together with an "App" on an ordinary smartphone (in the planned study, iPhone 4S). The result is presented within minutes and presence of hemolysis will be simultaneously detected on the device. The investigators speculate that the use of such a LDH test could serve as a diagnostic help for health-care staff in Vietnam in making the decision when to send a potentially sick newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)