Breastfeeding Characteristics and Duration of Feeding Human Milk in Infants With Congenital Heart Disease
Future efforts to support feeding human milk in infants with CHD should emphasize practices that support maximal human milk production.
KEY FINDINGS: Future efforts to support feeding human milk in infants with CHD should emphasize practices that support maximal human milk production.
BACKGROUND: Although infants with congenital heart disease (CHD) are able to breastfeed successfully, the factors that affect feeding human milk across the first year are not well established. The aim of this study was to examine breastfeeding characteristics and their relationships to the exclusivity and duration of feeding human milk among infants with CHD.
DETAILS: Breastfeeding characteristics data from a cohort of 75 infants with CHD enrolled in a study that examined relationships among milk type and infant growth in the first year of life were analyzed. Infants whose mothers reported not having enough milk were exclusively fed human milk for a shorter duration than those who did not have this challenge ( P = .04); however, the duration of feeding any human milk did not differ ( P = .18). Average daily volume expressed at 1 month was positively related to the duration of exclusive human milk (β = .07, P = .04) and any human milk (β = .07, P = .04) feeding.
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Source: Russel, S. M., Lessen, R., Rovner, A. J., et al. (2024). Breastfeeding Characteristics and Duration of Feeding Human Milk in Infants With Congenital Heart Disease. The Journal of Perinatal & Neonatal Nursing. 2024; 38(1): 46-53. Published: January/March, 2024. DOI: 10.1097/JPN.0000000000000740.
Efficacy and Safety of Xanomeline-Trospium Chloride in Schizophrenia
In this phase 3, double-blind, randomized, placebo-controlled trial in 256 people with schizophrenia, xanomeline-trospium was associated with a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale total score compared with placebo. Xanomeline-trospium was generally well tolerated; the most common adverse events were primarily gastrointestinal effects, which were mild or moderate in intensity and generally transient in nature.
KEY FINDINGS: Xanomeline-trospium was efficacious and well tolerated in people with schizophrenia experiencing acute psychosis. These findings, together with the previously reported and consistent results from the EMERGENT-1 and EMERGENT-2 trials, support the potential of xanomeline-trospium to be the first in a putative new class of antipsychotic medications without D2 dopamine receptor blocking activity.
BACKGROUND: A significant need exists for new antipsychotic medications with different mechanisms of action, greater efficacy, and better tolerability than existing agents. Xanomeline is a dual M1/M4 preferring muscarinic receptor agonist with no direct D2 dopamine receptor blocking activity. KarXT combines xanomeline with the peripheral muscarinic receptor antagonist trospium chloride with the goal of reducing adverse events due to xanomeline-related peripheral muscarinic receptor activation. In prior trials, xanomeline-trospium chloride was effective in reducing symptoms of psychosis and generally well tolerated in people with schizophrenia. Purpose of this study is to evaluate the efficacy and safety of xanomeline-trospium vs placebo in adults with schizophrenia.
DETAILS: EMERGENT-3 (NCT04738123) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 5-week trial of xanomeline-trospium in people with schizophrenia experiencing acute psychosis, conducted between April 1, 2021, and December 7, 2022, at 30 inpatient sites in the US and Ukraine. Data were analyzed from February to June 2023. Participants were randomized 1:1 to receive xanomeline-trospium chloride (maximum dose xanomeline 125 mg/trospium 30 mg) or placebo for 5 weeks. The prespecified primary end point was change from baseline to week 5 in Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcome measures were change from baseline to week 5 in PANSS positive subscale score, PANSS negative subscale score, PANSS Marder negative factor score, Clinical Global Impression-Severity score, and proportion of participants with at least a 30% reduction in PANSS total score. Safety and tolerability were also evaluated. A total of 256 participants (mean [SD] age, 43.1 [11.8] years; 191 men [74.6%]; 156 of 256 participants [60.9%] were Black or African American, 98 [38.3%] were White, and 1 [0.4%] was Asian) were randomized (125 in xanomeline-trospium group and 131 in placebo group). At week 5, xanomeline-trospium significantly reduced PANSS total score compared with placebo (xanomeline-trospium , -20.6; placebo, -12.2; least squares mean difference, -8.4; 95% CI, -12.4 to -4.3; P < .001; Cohen d effect size, 0.60). Discontinuation rates due to treatment-emergent adverse events (TEAEs) were similar between the xanomeline-trospium (8 participants [6.4%]) and placebo (7 participants [5.5%]) groups. The most common TEAEs in the xanomeline-trospium vs placebo group were nausea (24 participants [19.2%] vs 2 participants [1.6%]), dyspepsia (20 participants [16.0%] vs 2 participants [1.6%]), vomiting (20 participants [16.0%] vs 1 participant [0.8%]), and constipation (16 participants [12.8%] vs 5 participants [3.9%]). Measures of extrapyramidal symptoms, weight gain, and somnolence were similar between treatment groups.
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Source: Kaul, I., Sawchak, S., Walling, D. P., et al. (2024). Efficacy and Safety of Xanomeline-Trospium Chloride in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2024; 81(8): 749-756. Published: August, 2024. DOI: 10.1001/jamapsychiatry.2024.0785.
Strategies to Improve Sleep Quality in Intensive Care Unit Patients
The most effective way to improve sleep for intensive care unit patients is to use a combination of pharmacologic and nonpharmacologic interventions. Among the latter, the use of earplugs and sleep masks is simplest.
KEY FINDINGS: The most effective way to improve sleep for intensive care unit patients is to use a combination of pharmacologic and nonpharmacologic interventions. Among the latter, the use of earplugs and sleep masks is simplest.
BACKGROUND: Patients in intensive care units are exposed to many factors that can negatively affect the quality of their sleep. Aim of the study is to describe the latest findings regarding sleep quality improvement in intensive care unit patients.
DETAILS: An integrative literature review was conducted in the CINAHL, PubMed, Cochrane Library, and MEDLINE databases in April and May 2023. The following keywords were used: intensive care units, promotion, sleep quality, and sleep. The Critical Appraisal Skills Programme tool was used to assess the quality of individual studies. Of 159 articles identified, 10 were included in the final analysis. The findings were grouped into 4 thematic categories: consequences of poor sleep quality, factors affecting sleep quality, pharmacologic ways to improve sleep quality, and nonpharmacologic ways to improve sleep quality. Various pharmacologic and nonpharmacologic treatments are used in clinical settings. Nonpharmacologic interventions include sleep masks, earplugs, reductions in alarm volume, and reductions in nighttime interventions. Relaxation techniques include aromatherapy, music therapy, and acupressure.
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Source: Persolja, M. and Roznik, A. et al. (2024). Strategies to Improve Sleep Quality in Intensive Care Unit Patients. Crit Care Nurse. 2024; 44(4): 47-56. Published: August 1, 2024. DOI: 10.4037/ccn2024368.
An Investigation of Trachoma Vaccine Regimens by the Chlamydia Vaccine CTH522 Administered With Cationic Liposomes in Healthy Adults (CHLM-02)
CTH522, adjuvanted with CAF01 or CAF09b, is safe and immunogenic, with 85 µg CTH522-CAF01 inducing robust serum IgG binding titres. Intradermal vaccination conferred systemic IgG neutralisation breadth, and topical ocular administration increased ocular IgA formation. These findings indicate CTH522 vaccine regimens against ocular trachoma and urogenital chlamydia for testing in phase 2, clinical trials.
Summary
A Phase 1, Double-Blind Trial
[Posted 13/Aug/2024]
AUDIENCE: Infectious Disease, Nursing, Ob/Gyn
KEY FINDINGS: CTH522, adjuvanted with CAF01 or CAF09b, is safe and immunogenic, with 85 μg CTH522-CAF01 inducing robust serum IgG binding titres. Intradermal vaccination conferred systemic IgG neutralisation breadth, and topical ocular administration increased ocular IgA formation. These findings indicate CTH522 vaccine regimens against ocular trachoma and urogenital chlamydia for testing in phase 2, clinical trials.
BACKGROUND: There is no vaccine against the major global pathogen Chlamydia trachomatis; its different serovars cause trachoma in the eye or chlamydia in the genital tract. Authors did a clinical trial administering CTH522, a recombinant version of the C trachomatis major outer membrane molecule, in different dose concentrations with and without adjuvant, to establish its safety and immunogenicity when administered intramuscularly, intradermally, and topically into the eye, in prime-boost regimens.
DETAILS: CHLM-02 was a phase 1, double-blind, randomised, placebo-controlled trial at the National Institute for Health Research Imperial Clinical Research Facility, London, UK. Participants were healthy men and non-pregnant women aged 18-45 years, without pre-existing C trachomatis genital infection. Participants were assigned into six groups by the electronic database in a pre-prepared randomisation list (A-F). Participants were randomly assigned (1:1:1:1:1) to each of the groups A-E (12 participants each) and 6 were randomly assigned to group F. Investigators were masked to treatment allocation. Groups A-E received investigational medicinal product and group F received placebo only. Two liposomal adjuvants were compared, CAF01 and CAF09b. The groups were intramuscular 85 µg CTH522-CAF01, or placebo on day 0 and two boosters or placebo at day 28 and 112, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (A); intramuscular 85 µg CTH522-CAF01, two boosters at day 28 and 112 with additional topical ocular administration of CTH522, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (B); intramuscular 85 µg CTH522-CAF01, two boosters at day 28 and 112 with additional intradermal administration of CTH522, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (C); intramuscular 15 µg CTH522-CAF01, two boosters at day 28 and 112, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (D); intramuscular 85 µg CTH522-CAF09b, two boosters at day 28 and 112, and a mucosal recall with either placebo or CTH522 topical ocularly at day 140 (E); intramuscular placebo (F). The primary outcome was safety; the secondary outcome (humoral immunogenicity) was the percentage of trial participants achieving anti-CTH522 IgG seroconversion, defined as four-fold and ten-fold increase over baseline concentrations. Analyses were done as intention to treat and as per protocol. The trial is registered with ClinicalTrials.gov, NCT03926728, and is complete. Between Feb 17, 2020 and Feb 22, 2022, of 154 participants screened, 65 were randomly assigned, and 60 completed the trial (34 [52%] of 65 women, 46 [71%] of 65 White, mean age 26.8 years). No serious adverse events occurred but one participant in group A2 discontinued dosing after having self-limiting adverse events after both placebo and investigational medicinal product doses. Study procedures were otherwise well tolerated; the majority of adverse events were mild to moderate, with only seven (1%) of 865 reported as grade 3 (severe). There was 100% four-fold seroconversion rate by day 42 in the active groups (A-E) and no seroconversion in the placebo group. Serum IgG anti-CTH522 titres were higher after 85 µg CTH522-CAF01 than 15 µg, although not significantly (intention-to-treat median IgG titre ratio groups A-C:D=5.6; p=0.062), with no difference after three injections of 85 µg CTH522-CAF01 compared with CTH522-CAF09b (group E). Intradermal CTH522 (group C) induced high titres of serum IgG anti-CTH522 neutralising antibodies against serovars B (trachoma) and D (urogenital). Topical ocular CTH522 (group B) at day 28 and 112 induced higher total ocular IgA compared with baseline (p0.001). Participants in all active vaccine groups, particularly groups B and E, developed cell mediated immune responses against CTH522.
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Source: Pollock, K. M., Borges, A. H., Cheeseman, H. M., et al. (2024). An Investigation of Trachoma Vaccine Regimens by the Chlamydia Vaccine CTH522 Administered With Cationic Liposomes in Healthy Adults (CHLM-02): A Phase 1, Double-Blind Trial. The Lancet. 2024; 24(8): 829-844. Published: August, 2024. DOI: 10.1016/S1473-3099(24)00147-6.
Does Mixing Activated Charcoal With Cola Improve Tolerability Without Affecting Pharmacokinetics?
In this small study, there was no difference in preference for activated charcoal alone or a cola-activated charcoal mixture across a range of palatability questions. On an individual level, some participants preferred the activated charcoal-cola mixture, and some preferred the activated charcoal alone.
Summary
A Randomized Controlled Crossover Trial
[Posted 6/Aug/2024]
AUDIENCE: Nursing, Emergency Medicine
KEY FINDINGS: The absorption of acetaminophen in an overdose model is no different when participants received activated charcoal alone or a cola-activated charcoal mixture as suggested by area under the curve. In this small study, there was no difference in preference for activated charcoal alone or a cola-activated charcoal mixture across a range of palatability questions. On an individual level, some participants preferred the activated charcoal-cola mixture, and some preferred the activated charcoal alone.
BACKGROUND: Activated charcoal is the most common form of gastrointestinal decontamination used for the poisoned patient. One limitation to its use is patient tolerability due to palatability. Some recommend mixing activated charcoal with cola to improve palatability. An important question is whether mixing activated charcoal with cola affects the ability of the activated charcoal to adsorb xenobiotic.
DETAILS: This was a prospective randomized controlled crossover trial. Five healthy adults aged 18 to 40 years were recruited. Participants received 45 mg/kg acetaminophen rounded down to the nearest whole tablet. One hour later, they were randomized to receive 50 g of an activated charcoal-water premixture alone or mixed with cola. Acetaminophen levels were collected. The area under the curve of acetaminophen concentrations over time was measured as a marker for degree of absorption. Participants also completed an appeal questionnaire in which they rated the activated charcoal preparations. Participants would then return after at least 7 days to repeat the study with the other activated charcoal preparation. Four male participants and 1 female participant were recruited. There was no statistical difference in preference score for activated charcoal alone versus the cola-activated charcoal mixture. There was no statistical difference in the area under the curve of acetaminophen concentrations over time between activated charcoal alone and the cola-activated charcoal mixture. Of note, the study is limited by the small sample size, limiting its statistical power.
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Source: Keenan, M., Wojcik, S., Clemency, B. M., et al. (2024). Does Mixing Activated Charcoal With Cola Improve Tolerability Without Affecting Pharmacokinetics? A Randomized Controlled Crossover Trial. Journal of Emergency Nursing. 2024; 50(4): 516-522. Published: July, 2024. DOI: 10.1016/j.jen.2024.03.001.
Improving the Ability of Nursing Students in Neonatal Resuscitation by Using the Helping Babies Breathe Program
Resuscitation training through the use of a high-similarity simulator was significantly more effective than utilizing a low-similarity simulator when performing basic neonatal resuscitation
KEY FINDINGS: Resuscitation training through the use of a high-similarity simulator was significantly more effective than utilizing a low-similarity simulator when performing basic neonatal resuscitation
BACKGROUND: Nursing graduates must have sufficient skills to perform adequately in newborn resuscitations. New nurses should be provided with appropriate situations in order to practice the necessary skills required during a newborn resuscitation. This study aimed to improve the performance of nursing students during neonatal resuscitations through the use of a Helping Babies Breathe Program.
DETAILS: This quasi-experimental study with a control group (simulator with low similarity) and an interventional group (Helping Babies Breathe Program) was conducted on 84 eighth-semester nursing students studying at Isfahan University of Medical Sciences, Iran. A resuscitation workshop was held for a single day for 5 h with students performing standard practices for each step of the resuscitation. Knowledge and skills of students were assessed using two scenarios and a standardized checklist. The mean score of knowledge and basic neonatal resuscitation skills were significantly different between the two groups before and immediately after training, as well as Post-Internship (p < 0.05). The highest score of knowledge (17.38) belonged to the intervention group. Appropriate skills are critically important when performing bag-valve-mask ventilation. Before the intervention occurred, students in the interventional group obtained the lowest scores in resuscitation skills; however, after the intervention, all interventional group students obtained a full score and demonstrated the necessary skills required for effective newborn resuscitations.
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Source: Nazari, A., Namnabati, M., and Ajoodanian, N. (2024). Improving the Ability of Nursing Students in Neonatal Resuscitation by Using the Helping Babies Breathe Program: A Quasi-Experimental Study. Journal of Neonatal Nursing. 2024; 29(3): 453-458. Published: June, 2024. DOI: 10.1016/j.jnn.2022.06.005.
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