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To examine the effects of web neonatal intensive care unit diaries on the mental health, quality of life, sleep quality, care ability, and hormone levels of parents of preterm infants in the neonatal intensive care unit. Prospective randomized controlled parallel-group clinical trial. Maternal and Child Health Hospital, Fujian, China. The control group received routine neonatal intensive care unit care, while the intervention group received a web neonatal intensive care unit diary based on routine care. Outcomes, including anxiety, depression, and post-traumatic stress disorder symptoms, quality of life, sleep quality, care ability, and cortisol and melatonin levels, were evaluated at T1 (Time 1, before the intervention), T2 (Time 2, immediately after the intervention), and T3 (Time 3, 1 month after the intervention). Seventy pairs of parents of preterm infants in the neonatal intensive care unit were randomly allocated to two groups: intervention (n = 35) and control (n = 35). The anxiety scores in the intervention group were significantly lower at T2 and T3 than those in the control group (P < 0.001). The care ability scores in the intervention group were significantly higher at T2 and T3 (P < 0.001). The prevalence of post-traumatic stress disorder at T3 was significantly different between the groups (P = 0.040). No significant differences were observed in the quality of life or sleep quality between the groups at T2 and T3 (P > 0.05). No significant differences were observed in cortisol and melatonin levels between the groups (P > 0.05). Web neonatal intensive care unit diaries effectively relieved anxiety symptoms, reduced the prevalence of post-traumatic stress disorder, and enhanced the care abilities of parents of preterm infants in the neonatal intensive care unit. Web neonatal intensive care unit diary can be considered in clinical practice as a convenient psychological intervention method, especially among parents of preterm infants in the neonatal intensive care unit.

The Children's Hospitals Neonatal Consortium is a multicenter collaboration of leaders from 27 regional neonatal intensive care units (NICUs) who partnered with the Children's Hospital Association to develop the Children's Hospitals Neonatal Database (CHND), launched in 2010. The purpose of this report is to provide a first summary of the population of infants cared for in these NICUs, including representative diagnoses and short-term outcomes, as well as to characterize the participating NICUs and institutions. During the first 2 1/2 years of data collection, 40910 infants were eligible. Few were born inside these hospitals (2.8%) and the median gestational age at birth was 36 weeks. Surgical intervention (32%) was common; however, mortality (5.6%) was infrequent. Initial queries into diagnosis-specific inter-center variation in care practices and short-term outcomes, including length of stay, showed striking differences. The CHND provides a contemporary, national benchmark of short-term outcomes for infants with uncommon neonatal illnesses. These data will be valuable in counseling families and for conducting observational studies, clinical trials and collaborative quality improvement initiatives.

Newborns are subjected to painful attempts in the early days of their lives due to medical requirements. Breastfeeding and innovative devices such as ShotBlocker® are used to alleviate pain. This study was planned to evaluate the effect of non-pharmacological methods on newborns’ pain and comfort level during the heel lance procedure in newborns. The study was a single-center, randomized controlled trial. This study was conducted in the first-level neonatal intensive care unit between August 2021 and September 2022. Ninety-six newborns were included in this study based on inclusion criteria. The newborns were randomly assigned to four groups: (a) breastfeeding, (b) ShotBlocker®, (c) breastfeeding + ShotBlocker®, and (d) standard care. Pain and comfort levels of newborns were evaluated according to the Neonatal Infant Pain Scale and the Newborn Comfort Behavior Scale before, during, and after the heel lance procedure. Crying time, heart rate, and oxygen saturation were recorded. The difference between the groups in terms of average crying time (p = 0.001) and comfort levels after the procedure (p = 0.001) was statistically significant. There was no difference in pain during and after the procedure. As a result of multiple analyses of variance in repeated measurements, a difference was found in comfort scores in terms of group, time, and group-time interaction (p < 0.05). The breastfeeding + ShotBlocker® group had the lowest mean crying time. There was no difference in procedure-related pain scores between the groups. The most comfortable groups after heel lance were the breastfeeding and breastfeeding + ShotBlocker® groups. Breastfeeding, currently the gold non-pharmacological standard, increased comfort levels during the heel lance procedure. The breastfeeding + ShotBlocker® had a significant reduction in crying time and a significantly greater post-procedural comfort level (Clinical Trials number: NCT05246787).

Preterm infants in the neonatal intensive care unit are exposed to various painful procedures; thus, different non-pharmacological pain control techniques are used to alleviate pain. The aim of this study is to determine the effect of Yakson and Gentle Human Touch (GHT) methods during endotracheal suctioning on pain, comfort, and physiological parameters response in preterm infants. A randomised controlled crossover trial. This study was conducted in the neonatal intensive care unit between July 2022 and June 2023. Thirty infants were included in this study based on inclusion criteria. The samples randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale (N-PASS) and COMFORTneo were used to collect the data. The pain and comfort scores of preterm infants who received GHT and Yakson touch during and after endotracheal suctioning were statistically significantly lower than the infants in the routine care (p < 0.001). It was determined that the difference was in favour of the Yakson group (p < 0.001). The infants who received GHT and Yakson application had lower heart rates and higher oxygen saturation levels after the application compared to the control group (p < 0.001). The application of Yakson and GHT during endotracheal aspiration in preterm infants has been found to be effective in pain and comfort management, as well as in the regulation of physiological parameters.

Objective: Frequent parental visits are likely to benefit infants in a neonatal intensive care unit (NICU), particularly extremely low birth weight (ELBW; ⩽1000 g) survivors. Parking costs (⩾$10 per visit in our center) may deter visitation, especially for low-income parents. We assessed whether free parking (FP) decreased survivors’ length of stay (LOS). Study Design: Parents ( N =138) of ELBW infants (7 to 14 days old) were randomized to usual care (UC; n =66) or FP ( n =72). The primary outcome was LOS. Results: Among survivors ( n =116), LOS was not significantly less with FP than UC (means: FP=89, UC=102 days, P =0.22; medians: FP=82, UC=84 days, P =0.30). Groups did not differ significantly on proportion of visit days (FP=0.69, UC=0.72, P =0.47), parental involvement, knowledge/skills and satisfaction. Post hoc analyses found that parents with a greater income, a car and fewer children visited more. Conclusion: More potent interventions than FP are needed to increase parental visits and reduce LOS for ELBW infants in disadvantaged urban populations.

This study examined differences in learning outcomes among newborn intensive care unit (NICU) workers who underwent virtual reality simulation (VRS) emergency evacuation training versus those who received web-based clinical updates (CU). Learning outcomes included a) knowledge gained, b) confidence with evacuation, and c) performance in a live evacuation exercise. A longitudinal, mixed-method, quasi-experimental design was implemented utilizing a sample of NICU workers randomly assigned to VRS training or CUs. Four VRS scenarios were created that augmented neonate evacuation training materials. Learning was measured using cognitive assessments, self-efficacy questionnaire (baseline, 0, 4, 8, 12 months), and performance in a live drill (baseline, 12 months). Data were collected following training and analyzed using mixed model analysis. Focus groups captured VRS participant experiences. The VRS and CU groups did not statistically differ based upon the scores on the Cognitive Assessment or perceived self-efficacy. The virtual reality group performance in the live exercise was statistically (P<.0001) and clinically (effect size of 1.71) better than that of the CU group. Training using VRS is effective in promoting positive performance outcomes and should be included as a method for disaster training. VRS can allow an organization to train, test, and identify gaps in current emergency operation plans. In the unique case of disasters, which are low-volume and high-risk events, the participant can have access to an environment without endangering themselves or clients. (Disaster Med Public Health Preparedness. 2019;13:301-308).

In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia. In this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing. Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79–0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08–1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group. There is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery. National Institute for Health Research Health Technology Assessment Programme.

Intrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. We did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We recommended that treatment should be continued from enrolment until the infant's birth. The primary outcome was a composite of perinatal death (in-utero fetal death after randomisation or known neonatal death up to 7 days after birth), preterm delivery (<37 weeks' gestation), or neonatal unit admission for at least 4 h (from birth until hospital discharge). Each infant was counted once within this composite. All analyses were done according to the intention-to-treat principle. The trial was prospectively registered with the ISRCTN registry, number 91918806. Between Dec 23, 2015, and Aug 7, 2018, 605 women were enrolled and randomly allocated to receive ursodeoxycholic acid (n=305) or placebo (n=300). The primary outcome analysis included 304 women and 322 infants in the ursodeoxycholic acid group, and 300 women and 318 infants in the placebo group (consent to use data was withdrawn for 1 woman and 2 infants). The primary composite outcome occurred in 74 (23%) of 322 infants in the ursodeoxycholic acid group and 85 (27%) of 318 infants in the placebo group (adjusted risk ratio 0·85 [95% CI 0·62–1·15]). Two serious adverse events were reported in the ursodeoxycholic acid group and six serious adverse events were reported in the placebo group; no serious adverse events were regarded as being related to treatment. Treatment with ursodeoxycholic acid does not reduce adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Therefore, its routine use for this condition should be reconsidered. National Institute for Health Research Efficacy and Mechanism Evaluation Programme.

Objectives: To assess progress of neonatal intensive care units (NICUs) participating in the Vermont Oxford Network iNICQ 2015: Alarm Safety Collaborative in achieving Joint Commission 2014 alarm safety goals with respect to oximeters, and to compare patient-level oxygen saturation (SpO 2 ) and oximeter alarm data to local policies. Study Design: Prospective multicenter audits in February and August 2015 assessed implementation of policies addressing Joint Commission 2014 Alarm Safety goals, and ascertained SpO 2 targets, oximeter alarm settings and compliance with policy-specified SpO 2 targets and alarms. Results: Eighty-six NICUs completed both audits. Of 13 policies addressing mandated goals, median (interquartile range) 8 (5, 9) policies were implemented at audit 1 and 9 (6, 11) at audit 2 ( P =0.004). At audit 1, 28 NICUs had implemented ⩾9 policies versus 47 at audit 2. For 794 infants <31 weeks gestation, <36 weeks postmenstrual age, and on supplemental oxygen, median SpO 2 target lower limit was 88% (interquartile range 87%, 90%; range 75% to 94%), upper limit 95% (interquartile range 94%, 96%; range 85% to 100%). High oximeter alarm was set according to local policy for 63% of infants, for whom SpO 2 >97% was less frequent than when high alarm was not set to policy (10.1% vs 21.5%, P =0.006). Conclusions: Participating NICUs showed significant progress between audits in their implementation of Joint Commission Alarm Safety goals for oximeter monitoring. Oximeter high alarm not set per local policy is associated with increased hyperoxemia in preterm infants. Recommendations to standardize oxygen saturation targets for infants at risk for oxygenation-related outcomes have not been widely adopted.

OBJECTIVE To improve the patient safety of very-low-birthweight infants in neonatal departments in Germany. DESIGN Multicenter cohort study with a baseline (24 months), an intervention (12 months), and a postinterventional follow-up period (12 months) and time series analysis. STUDY POPULATION Very-low-birthweight patients from 32 neonatal departments in Germany. METHODS Neonatal departments showing a standardized infection ratio of bloodstream infection 10% higher than the expected number (standardized infection ratio ≥1.1) were invited to participate in the study. To reduce the occurrence of primary bloodstream infections, evidence-based bundles to improve catheter maintenance routines, insertion practice, and hand-hygiene compliance were implemented in the participating infirmaries. RESULTS Thirty-four departments participated in the study and 32 reported data. In total, 6,222 very-low-birthweight infants with 231,868 patient-days and 1,405 cases of bloodstream infections were analyzed. In the baseline period the pooled mean bloodstream infection rate was 6.63 (95% CI, 6.17-7.12) per 1,000 patient-days. The bloodstream infection rate decreased in the intervention period to 5.68 (relative risk, 0.86 [95% CI, 0.76-0.97]) and in the 1-year follow-up period to 5.31 per 1,000 patient-days (relative risk, 0.80 [95% CI, 0.70-0.92]). The multivariable time series analysis of monthly aggregated data showed a significant change in the slope for the frequency of bloodstream infections from the start to the end of the intervention (change in slope incidence rate ratio, 0.97; P=.001). CONCLUSION The implementation of an intervention bundle is feasible and can reduce bloodstream infections in neonatal departments. Infect Control Hosp Epidemiol 2016;37:798-804.