Protecting Children From Tobacco Smoke Exposure: A Randomized Controlled Trial of Project Zero Exposure.

INTRODUCTION: Young children are vulnerable to harm from tobacco smoke exposure (TSE). This study assessed the effect of Project Zero Exposure-an intervention program designed to help parents protect children from TSE-on children's exposure. METHODS: Randomized controlled trial of a home-based, theory-driven intervention. Parents of young children (<8 y) in families with a smoking parent were eligible. The intervention included feedback on child TSE (hair nicotine), and home air quality (PM2.5), with motivational interviewing. Families were randomized to: intervention group (IG, N = 69), regular control group (RCG, N = 70), or to a secondary enhanced control group, (ECG, N = 20). Child hair samples were taken at baseline and follow-up. We report on child TSE in the IG versus RCG at six months. RESULTS: Most enrolled families completed the trial (IG: 98.6%[68/69], RCG: 97.1%[68/70]). Log hair nicotine (LHN [ng/mg]) decreased in both the IG (Baseline: -1.78 ± 1.91, Follow-up: -2.82 ± 1.87, p = .003) and RCG (Baseline: -1.79 ± 1.54, Follow-up: -2.85 ± 1.73, p = .002), but did not differ between groups at study end (p = .635). Three of five parentally-reported outcomes showed improvement over time in the IG, and one in the RCG. Among IG participants, 90% found hair nicotine feedback useful. CONCLUSIONS: No difference between the intervention and control groups was found on the objective biomarker, LHN. Child TSE decreased during the trial in intervention and control groups. Trial participation, which included hair nicotine monitoring, may have contributed to decreasing exposure in both groups. Concurrent control group improvements may partially explain lack of proven intervention benefit. Biomarker monitoring warrants further investigation for reduction of child TSE. IMPLICATIONS: Project Zero Exposure is an intervention program designed to help parents protect their children from TSE. Results from the randomized controlled trial of the program showed no difference between groups at study end, but a clear and substantial reduction in child exposure to tobacco smoke from beginning to end of the trial, in both intervention and control groups. Biomarker monitoring, a key element of the trial, was used with all participants. Biomarker monitoring of child exposure to tobacco smoke may help parents become aware of their child's exposure and better protect them, and should be explored as a means to reduce child TSE. Clinical Trial Registration: NCT02867241.

Protecting Young Children From Tobacco Smoke Exposure: A Pilot Study of Project Zero Exposure.

BACKGROUND: Tobacco smoke exposure (TSE) harms children, who are often "captive smokers" in their own homes. Project Zero Exposure is a parent-oriented, theory-based intervention designed to reduce child TSE. This paper reports on findings from the pilot study, which was conducted in Israel from 2013 to 2014. METHODS: The intervention consisted of motivational interviews, child biomarker and home air quality feedback, a Web site, a video, and self-help materials. The primary outcome was child TSE as measured by hair nicotine. Secondary outcome measures were air nicotine and particulate matter, parental reports of TSE, parental smoking behavior, and TSE child protection. A single-group pre- and posttest design was used. RESULTS: Twenty-six of the 29 recruited families completed the study. The intervention was feasible to implement and acceptable to participants. Among the 17 children with reliable hair samples at baseline and follow-up, log hair nicotine dropped significantly after the intervention (P = .04), hair nicotine levels decreased in 64.7% of children, and reductions to levels of nonexposed children were observed in 35.3% of children. The number of cigarettes smoked by parents (P = .001) and parent-reported child TSE declined (P = .01). Logistical issues arose with measurement of all objective measures, including air nicotine, which did not decline; home air particulate matter; and hair nicotine. CONCLUSIONS: A program based on motivational interviewing and demonstrating TSE and contamination to parents in a concrete and easily understandable way is a promising approach to protect children from TSE. Further research is needed to enhance current methods of measurement and assess promising interventions.

[THE APPROACH TO NAUSEA AND VOMITING IN PREGNANCY].

Nausea and vomiting of pregnancy (NVP) is the most prevalent medical condition during gestation. Approximately 85% of pregnant women suffer from some degree of this condition, while hyperemesis gravidarum (HG), the most severe form, affects up to 2% of women. Although being the leading cause for hospitalization during pregnancy, NVP has received little attention from the medical community. NVP negatively affects women's quality of life, household activity and work productivity. In Canada, the financial cost of NVP, ranges from $132 to $653 per woman/week. In extreme cases, severe NVP results in therapeutic abortions. On the other hand, NVP has been shown to have a protective effect against spontaneous abortions and congenital malformations. Lately, there has been an interest in the hypothesis that NVP is a mechanism protecting the fetus from phytochemicals. Early treatment can prevent future complications and deterioration of the symptoms. Various studies have demonstrated the effectiveness and safety of antiemetic therapy in pregnancy. However, fear of teratogenicity and lack of clinical guidelines lead to trial and error NVP management. We present an updated algorithm for the management of NVP.

Intestinal obstruction in pregnancy by ondansetron.

BACKGROUND: Ondansetron use for nausea and vomiting during pregnancy has increased in the last years, although its maternal and fetal safety is not conclusive. CASE: We describe a case of intestinal obstruction in a pregnant woman with severe nausea and vomiting of pregnancy treated with ondansetron, which is known to slow gut motility. CONCLUSION: The spontaneous reporting system of WHO confirms that this potentially life threatening complication is more common than what the peer review literature may suggest and needs to be looked into carefully, especially in view of the wide spread off-label use for NVP.

The efficiency of intraosseous human growth hormone administration: a feasibility pilot study in a rabbit model.

BACKGROUND: The use of protein- and peptide-based drugs in the treatment of disease has significantly increased in recent years. However, their chemical and physical properties make them unsuitable for simple oral delivery. OBJECTIVE: The objective of this proof-of-concept study was to examine the feasibility of protein administered via intraosseous (IO) injection. Human growth hormone (GH), a 22-kd protein, served as the model protein. RESULTS: An indwelling IO needle and intravenous (IV) line were placed in four New Zealand white male rabbits, and 50, 100, 200, or 400 µg/kg of GH were injected. Blood samples were taken at different time points and analyzed for GH concentration. There were no significant pharmacokinetic differences between the IO and IV routes. For the 400 µg/kg dose, the area under the serum GH concentration time curve was 100.55 ± 46.7 µg/min*mL with IV administration and 84.6 ± 34 µg/min*mL for IO (P = .73 compared to the IV route), Cmax measured 11.2 ± 5 µg/L and Tmax 0.9 ± 0.7 minutes. For the 200 µg/kg dose, the area under the curve was 68.5 ± 16.7 µg/min*mL with IV administration, and 85.1 ± 1.5 µg/min*mL (P = .39) for IO, Cmax measured 8.13 ± 2.44 µg/L and Tmax 1.92 ± 1.06 minutes. CONCLUSIONS: The findings confirm that a large protein (22 kd) can be administered via IO injection, reaching blood levels comparable to IV injection. Further studies with a larger number of animals are required to evaluate the pharmacokinetics and pharmacodynamics of high-molecular-weight proteins injected by the IO route.

Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study.

OBJECTIVES: To compare the effects of a single nocturnal dose of 3 honey products (eucalyptus honey, citrus honey, or labiatae honey) to placebo (silan date extract) on nocturnal cough and difficulty sleeping associated with childhood upper respiratory tract infections (URIs). METHODS: A survey was administered to parents on 2 consecutive days, first on the day of presentation, when no medication had been given the previous evening, and the following day, when the study preparation was given before bedtime, based on a double-blind randomization plan. Participants included 300 children aged 1 to 5 years with URIs, nocturnal cough, and illness duration of ≤ 7 days from 6 general pediatric community clinics. Eligible children received a single dose of 10 g of eucalyptus honey, citrus honey, labiatae honey, or placebo administered 30 minutes before bedtime. Main outcome measures were cough frequency, cough severity, bothersome nature of cough, and child and parent sleep quality. RESULTS: In all 3 honey products and the placebo group, there was a significant improvement from the night before treatment to the night of treatment. However, the improvement was greater in the honey groups for all the CONCLUSIONS: Parents rated the honey products higher than the silan date extract for symptomatic relief of their children's nocturnal cough and sleep difficulty due to URI. Honey may be a preferable treatment for cough and sleep difficulty associated with childhood URI.

Beta1- or beta2-blockers to improve hemodynamics following endotracheal adrenaline administration.

BACKGROUND: The recommended dose for endotracheal adrenaline (0.02 mg/kg) causes a pronounced initial decrease in diastolic blood pressure which is detrimental at the initial phase of cardiopulmonary resuscitation. This effect was previously attributed to an early and preferential stimulation of the beta-adrenergic receptors causing vasodilatation unopposed by an alpha-adrenergic vasoconstriction. We hypothesized that inhibition of the beta2-adrenoreceptors is responsible for prevention of the deleterious initial decrease in blood pressure that takes place following endotracheal administration of adrenaline. METHODS: Adrenaline (0.02 mg/kg) diluted with normal saline (5 ml) was injected into the endobronchial tree of anesthetized dogs 3 min following pretreatment with the non-selective beta-blocker propranolol, selective beta1-blocker metoprolol (0.1 mg/kg, i.v.), or without pre-treatment. Heart rate, blood pressure and arterial blood gases were monitored. RESULTS: The selective beta-blocker metoprolol was almost as effective as the non-selective beta-blocker propranolol in attenuating the initial decrease in blood pressure following endotracheally administered adrenaline, a phenomenon that was previously attributed to inhibition of beta-adrenoreceptors. CONCLUSIONS: The outcome of this study might be explained by a dose-related loss of cardioselectivity of metoprolol. Further studies are warranted to refine the pharmacological means to abort the initial blood pressure-lowering effect of endotracheally administered adrenaline.

Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study.

BACKGROUND: Women in their childbearing years often require drug therapy for allergic conditions. Loratadine, a newer nonsedating antihistamine, is often used because of its preferred side effect profile. To date no published data exist on the safety of loratadine use in pregnancy. OBJECTIVE: We sought to determine whether the use of loratadine in the first trimester of pregnancy was associated with an increased risk for major malformations. Secondary outcomes included rates of miscarriage, birth weights, and gestational age at delivery. METHODS: All women were prospectively enrolled from 4 participating centers. Detailed maternal medical history and drug exposures were collected at intake, whereas pregnancy complications and outcomes were collected at follow-up. A group of unexposed control subjects were recruited and followed up in a similar manner. RESULTS: This report includes follow-up on 161 loratadine exposed pregnancies and an equal number of unexposed control subjects. Maternal characteristics (age, pregnancy history, alcohol consumption, and smoking habits) were not different between the 2 groups. There were 5 malformations observed in the exposed group and 6 in the control group, which was not significantly different (P =.9) Similarly, the live birth rate, gestational age at delivery, and birth weights were not different between the 2 groups. CONCLUSION: These results suggest that loratadine use in pregnancy is not associated with a large risk for major malformations. Further studies are warranted to confirm these findings and to increase study power.

Should vasopressin replace adrenaline for endotracheal drug administration?

OBJECTIVE: Arginine vasopressin was established recently as a drug of choice in the treatment of cardiac arrest and in retractable ventricular fibrillation; however, the hemodynamic effect of vasopressin following endotracheal drug administration has not been fully elucidated. We compared the effects of endotracheally administered vasopressin vs. adrenaline on hemodynamic variables in a canine model, and we investigated whether vasopressin produces the same deleterious immediate blood pressure decrease as did endotracheal adrenaline in the canine model. DESIGN: Prospective controlled study. SETTING: Animal laboratory in Tel-Aviv University, Israel. SUBJECTS: Five adult mongrel dogs weighing 6.5-20 kg. INTERVENTIONS: Dogs were anesthetized; each dog was intubated orally, and both femoral arteries were cannulated for the measurement of arterial pressure and for sampling blood gases. Each dog was studied four times, 1 wk apart, by using the same protocol for injection and anesthesia: endotracheal placebo (10 mL NaCl 0.9%,), endotracheal vasopressin (1 units/kg), endobronchial adrenaline (0.1 mg/kg), and endotracheal adrenaline (0.1 mg/kg). Following placebo, vasopressin, and adrenaline instillation, five forced manual ventilations were delivered with an Ambu bag. Each dog was its own control. MEASUREMENTS AND MAIN RESULTS: Following placebo or drug administration, heart electrocardiography and arterial pressures were continuously monitored with a polygraph recorder for 1 hr. Endotracheal vasopressin produced an immediate increase of diastolic blood pressure (from 83 +/- 10 mm Hg [baseline] to 110 +/- 5 mm Hg at 1 min postinjection). This response lasted >1 hr. In contrast, both endotracheal and endobronchial administration of adrenaline produced an early and significant (p <.05) decrease in diastolic and mean blood pressures. The diastolic blood pressure increase from 85 +/- 10 mm Hg to 110 +/- 10 mm Hg took an ill-afforded 55 secs following endotracheal adrenaline. Diastolic blood pressure was significantly (p <.05) higher following vasopressin compared with adrenaline administration in both routes. CONCLUSIONS: Vasopressin accomplishes its hemodynamic effect, particularly on diastolic blood pressure, more rapidly, vigorously, and protractedly and to a significant degree compared with both endotracheal and endobronchial adrenaline. Evaluation of the effects of endotracheal vasopressin in a closed chest cardiopulmonary resuscitation model is recommended.

Endotracheal epinephrine: a call for larger doses.

UNLABELLED: Endotracheal administration of epinephrine 0.02 mg/kg (twice the IV dose) is recommended when IV access is unavailable during cardiopulmonary resuscitation. The standard IV dose has been considered too small for the endotracheal route by causing a detrimental decrease of arterial blood pressure (BP), presumably mediated by the beta-adrenergic receptor unopposed by alpha adrenergic vasoconstriction. We conducted a prospective, randomized, laboratory comparison of increasing doses of endotracheal epinephrine to ascertain the yet undetermined optimal dose of endotracheal epinephrine that would increase BP. After injecting normal saline (control), saline-diluted epinephrine (0.02, 0.035, 0.1, 0.2, and 0.3 mg/kg) was injected into the endotracheal tube of five anesthetized dogs at least 1 wk apart. Arterial blood samples for blood gases were collected before and at 14 time points up to 60 min after the drug administration. Heart rate and arterial BP were continuously monitored with a polygraph recorder. Only the 0.3 mg/kg dose successfully caused an increase in BP, observed 2 min after administration, and lasting for 10 min. An early decrease in BP was obviated only at a dose equivalent to 10-fold the currently recommended one. IMPLICATIONS: We conducted a prospective, randomized, laboratory comparison of increasing doses of endotracheal epinephrine to ascertain the yet undetermined optimal dose of endotracheal epinephrine that would increase arterial blood pressure (BP). A decrease in BP was obviated only at a dose equivalent to 10-fold the currently recommended one. Clinical studies using larger doses of endotracheal epinephrine and their use as first-line therapy in cardiac arrest are warranted.

Inadequate asthma treatment practices and noncompliance in Israel.

Childhood asthma morbidity and mortality are increasing despite improvements in asthma therapy. The changes over the past decade in the guidelines for treatment of children with severe asthma have led to a reduction in admissions and readmissions to the pediatric intensive care unit (PICU). The Israeli medical infrastructure is exemplary in its capability of extending appropriate medical services to its entire population. Our objective was to look at the background of preventive maintenance treatment and treatment during an acute episode in children admitted to PICUs with severe asthma, and to identify areas that could be targeted for change. A 5-year retrospective chart audit on acute asthma admissions was conducted in two PICUs of general community hospitals representative of the provision of medical care in Israel. The prehospitalization preventive management and acute treatment prior to PICU admission were evaluated, and the number of admissions and readmissions was recorded. The index admission was the first episode of acute asthma for only 3% of the children: 25% of patients required readmission, and 15% of these to the PICU. In spite of a proven history of acute exacerbations of the disease, only 60% were on continuous treatment between attacks, and 29% of them had abruptly discontinued treatment, most of them shortly before the onset of the index attack. Inhaled steroids were used as maintenance and preventive treatment by less than one-third of the children, with the other two-thirds receiving mainly beta-2 agonists drugs. In conclusion, an unacceptably large proportion of asthmatic children do not receive the recommended maintenance and preventive treatment because of poor compliance, lack of education, or insufficient healthcare provision. This has probably led to avoidable recurrences of acute asthma exacerbations and unnecessary use of PICU facilities. These findings suggest that steps for implementing recommended guidelines and an educational program are needed.