Survey of Korean pediatrician's perceptions of barriers to and improvements in breastfeeding.

BACKGROUND: Although the benefits of breastfeeding are broadly acknowledged with the efforts of the government and several medical societies, the rate of exclusive breastfeeding through 6 months is lower in Korea than in developed countries. PURPOSE: This study aimed to investigate pediatricians' perceptions of breastfeeding barriers and the current breastfeeding counseling environment and propose government policies to encourage breastfeeding in Korea. METHODS: Fourteen survey questions were developed during meetings of Korean Society of Breastfeeding Medicine experts. The Korean Pediatric Society emailed a structured questionnaire to domestic pediatricians registered as official members of the Korean Pediatric Society on May 4, 2021, and June 3, 2021. This study examined the survey responses received from 168 pediatricians. RESULTS: The 168 respondents included 62 professors, 53 paid doctors, and 53 private physicians. Breastfeeding was recommended by 146 Korean pediatricians (86.9%). However, only 99 responders (59%) currently provide breastfeeding counseling in hospitals. Most respondents stated providing less than 15 minutes of breastfeeding counseling time in the clinic. Moreover, 89.88% of the respondents responded that they would participate in breastfeeding counseling education if an appropriate breastfeeding counseling program was newly established. CONCLUSION: This study showed that, although Korean pediatricians had a positive attitude toward breastfeeding, limited counseling was provided for parents. Along with policy support to improve the medical environment through the establishment of an appropriate breastfeeding counseling program, high-quality counseling and an increased breastfeeding rate are expected.

Survey on the Status of Breastfeeding in Korean Medical Institution Workers.

BACKGROUND: Human breast milk is essential and provides irreplaceable nutrients for early humans. However, breastfeeding is not easy for various reasons in medical institution environments. Therefore, in order to improve the breastfeeding environment, we investigated the difficult reality of breastfeeding through questionnaire responses from medical institution workers. METHODS: A survey was conducted among 179 medical institution workers with experience in childbirth within the last five years. The survey results of 175 people were analyzed, with incoherent answers excluded. RESULTS: Of the 175 people surveyed, a total of 108 people (61.7%) worked during the day, and 33 people (18.9%) worked in three shifts. Among 133 mothers who stayed with their babies in the same nursing room, 111 (93.3%) kept breastfeeding for more than a month, but among those who stayed apart, only 10 (71.4%) continued breastfeeding for more than a month (P = 0.024). Ninety-five (88.0%) of daytime workers, 32 (94.1%) two-shift workers, and 33 (100%) three-shift workers continued breastfeeding for more than a month (P = 0.026). Workers in general hospitals tended to breastfeed for significantly longer than those that worked in tertiary hospitals (P = 0.003). A difference was also noted between occupation categories (P = 0.019), but a more significant difference was found in the comparison between nurses and doctors (P = 0.012). Longer breastfeeding periods were noted when mothers worked three shifts (P = 0.037). Depending on the period planned for breastfeeding prior to childbirth, the actual breastfeeding maintenance period after birth showed a significant difference (P = 0.002). Of 112 mothers who responded to the question regarding difficulties in breastfeeding after returning to work, 87 (77.7%) mentioned a lack of time caused by being busy at work, 82 (73.2%) mentioned the need for places and appropriate circumstances. CONCLUSION: In medical institutions, it is recommended that environmental improvements in medical institutions, the implementation of supporting policies, and the provision of specialized education on breastfeeding are necessary to promote breastfeeding.

Breastfeeding and vitamin D.

The recent re-emergence of vitamin D deficiency (VDD) and rickets among breastfed infants without adequate sunlight exposure and vitamin D supplementation has been reported worldwide. Breastfed infants are particularly vulnerable to VDD because of the low vitamin D content of breast milk, restricted sunlight exposure, increased pollution, and limited natural dietary sources of vitamin D. The prevalence of VDD in breastfed infants differs vastly between studies and nations at 0.6%-91.1%. The recommended intake of vitamin D for lactating mothers to optimize their overall vitamin D status and, consequently, of their breast milk is 200-2,000 IU/day, indicating a lack of consensus. Some studies have suggested that maternal high-dose vitamin D supplementation (up to 6,400 IU/day) can be used as an alternate strategy to direct infant supplementation. However, concern persists about the safety of maternal high-dose vitamin D supplementation. Direct infant supplementation is the currently available option to support vitamin D status in breastfed infants. The recommended dose for vitamin D supplementation in breastfed infants according to various societies and organizations worldwide is 200-1,200 IU/day. Most international guidelines recommend that exclusively or partially breastfed infants be supplemented with 400 IU/day of vitamin D during their first year of life. However, domestic studies on the status and guidelines for vitamin D in breastfed infants are insufficient. This review summarizes the prevalence of VDD in breastfed infants, vitamin D content of breast milk, and current guidelines for vitamin D supplementation of lactating mothers and infants to prevent VDD in breastfed infants.

Immunogenicity and safety profiles of a new MAV/06 strain varicella vaccine in healthy children: A multinational, multicenter, randomized, double-blinded, active-controlled phase III study.

Immunization is the most effective preventive strategy against varicella. While the Oka strain is commonly used for varicella vaccination worldwide, Korea widely uses the MAV/06 strain. A new live attenuated MAV/06 strain varicella vaccine (MG1111), which uses the new cell line Medical Research Council-5 for better viral propagation, was developed. MG1111 was approved by Korean health authorities. Here, we report the results of phase III, randomized, double-blind, multicenter study conducted in Korea and Thailand, which compared the immunogenicity and safety profiles of MG1111 versus the control vaccine, VarivaxTM. In total, 515 healthy children (12 month-12 years) were randomized 1:1 to receive either the MG1111 or control vaccine (MG1111: 258, Control: 257). The seroconversion rate (SCR) and geometric mean titer (GMT) were measured using the fluorescent antibody to membrane antigen (FAMA) test. The MG1111 group achieved a SCR of 97.9% (95% CI: 95.2-99.3) after vaccination. The lower limit of 95% CI for SCR difference (MG1111-VarivaxTM) was -4.0%, which was higher than the specified non-inferiority margin of -10%. Further, the GMT of the MG1111 increased from 2.0 to 74.2 (95% CI: 65.0-84.8) and the lower limits of the 95% CI for post-vaccination GMT ratios (MG1111/VarivaxTM) were 0.55 higher than the specified parameter of 0.5. Therefore, the MG1111 group was not statistically inferior to the control vaccine group in terms of SCR and GMT. Furthermore, the MG1111 and control vaccine groups were not significantly different in the percentage of participants showing adverse events-solicited, local, or systemic during 43-day period of observation and serious adverse events during 6 month of observation. The present results indicate that MG1111was not immunologically inferior to VarivaxTM, and safety profiles of MG1111 are similar to those of VarivaxTM.

Development of the Korean Developmental Screening Test for Infants and Children (K-DST).

BACKGROUND: Most developmental screening tools in Korea are adopted from foreign tests. To ensure efficient screening of infants and children in Korea, a nationwide screening tool with high reliability and validity is needed. PURPOSE: This study aimed to independently develop, standardize, and validate the Korean Developmental Screening Test for Infants and Children (K-DST) for screening infants and children for neurodevelopmental disorders in Korea. METHODS: The standardization and validation conducted in 2012-2014 of 3,284 subjects (4-71 months of age) resulted in the first edition of the K-DST. The restandardization and revalidation performed in 2015-2016 of 3.06 million attendees of the National Health Screening Program for Infants and Children resulted in the revised K-DST. We analyzed inter-item consistency and test-retest reliability for the reliability analysis. Regarding the validation of K-DST, we examined the construct validity, sensitivity and specificity, receiver operating characteristic curve analysis, and a criterion-related validity analysis. RESULTS: We ultimately selected 8 questions in 6 developmental domains. For most age groups and each domain, internal consistency was 0.73-0.93 and test-retest reliability was 0.77-0.88. The revised K-DST had high discriminatory ability with a sensitivity of 0.833 and specificity of 0.979. The test supported construct validity by distinguishing between normal and neurodevelopmentally delayed groups. The language and cognition domain of the revised K-DST was highly correlated with the K-Bayley Scales of Infant Development-II's Mental Age Quotient (r=0.766, 0.739), while the gross and fine motor domains were highly correlated with Motor Age Quotient (r=0.695, 0.668), respectively. The Verbal Intelligence Quotient of Korean Wechsler Preschool and Primary Scales of Intelligence was highly correlated with the K-DST cognition and language domains (r=0.701, 0.770), as was the performance intelligence quotient with the fine motor domain (r=0.700). CONCLUSION: The K-DST is reliable and valid, suggesting its good potential as an effective screening tool for infants and children with neurodevelopmental disorders in Korea.

Positive association of breastfeeding on respiratory syncytial virus infection in hospitalized infants: a multicenter retrospective study.

BACKGROUND: Breastfeeding reportedly reduces the overall frequency of infections. Respiratory syncytial virus (RSV), the most common respiratory pathogen in infants, involves recurrent wheezing and has a pathogenic mechanism related to airway structural damage. PURPOSE: This study aimed to investigate whether breastfeeding has a beneficial effect against RSV-induced respiratory infection compared to formula feeding among infants in Korea. METHODS: We retrospectively reviewed the medical records of infants under 1 year of age who were admitted with RSV infection between January 2016 and February 2018 at the department of pediatrics of 4 hospitals. We investigated the differences in clinical parameters such as cyanosis, chest retraction, combined infection, fever duration, oxygen use, oxygen therapy duration, intensive care unit (ICU) admission, and corticosteroid treatment of exclusive breast milk feeding (BMF), artificial milk formula fed (AMF), and mixed feeding (MF) groups. RESULTS: Among the 411 infants included in our study, 94, 161, and 156 were included in the BMF, MF, and AMF groups, respectively. The rates of oxygen therapy were significantly different among the BMF (4.3%), MF (8.1%), and AMF (13.5 %) groups (P=0.042). The odds ratios (ORs) for oxygen therapy was significantly higher in the AMF group than in the BMF group (adjusted OR, 3.807; 95% confidence interval, 1.22-11.90; P=0.021). The ICU admission rate of the BMF group (1.1%) was lower than that of the MF (3.5%) and AMF (4.5%) groups; however, the dissimilarity was not statistically significant (P=0.338). CONCLUSION: The severity of RSV infection requiring oxygen therapy was lower in the BMF than the AMF group. This protective role of human milk on RSV infection might decrease the need for oxygen therapy suggesting less airway damage.

Hyponatremia in children with respiratory infections: a cross-sectional analysis of a cohort of 3938 patients.

Hyponatremia can be a life-threatening illness among hospitalized children. The aims of this study were to evaluate the incidence and risk factors of hyponatremia in 3938 children who were admitted to the Cheil General Hospital and Women's Health Care Center with respiratory infections. Clinical data were collected, and multiplex RT-PCR analyses were done for various microorganisms. Hyponatremia was observed in 531 (13.5%) patients. The incidence of hyponatremia differed according to the respiratory tract infection (P < 0.0001) and microorganism (P = 0.001). In children with hyponatremia, the age at admission was significantly older (P < 0.0001), male gender was more frequent (P = 0.019), CRP was higher (P < 0.0001), and coinfection with multiple organisms was more common (P = 0.001) than in children without hyponatremia. In multivariate analyses, an older age at admission (P = 0.006), male gender (P = 0.004), and increased CRP (P < 0.0001) were independent risk factors. Sodium levels correlated negatively with WBC (P = 0.037), CRP (P < 0.0001), and number of hospital days (P = 0.020). The AUC values of age (0.586, P < 0.0001), CRP (0.599, P < 0.0001), and blood urea nitrogen (0.559, P < 0.0001) were all significant predictors of hyponatremia. This study is the first to show that the incidence of hyponatremia differs according to infecting microorganism and radiological findings.

Use of child safety seats during transportation of newborns.

PURPOSE: Child safety seats (CSS) are critical for the protection of children, in case of motor vehicle accidents. Although the national legislation mandates that all newborns must be placed in an appropriately installed CSS during transportation, people often do not perceive the importance of CSS and do not use it as recommended. The purpose of this survey was to understand the use of CSS for the safe transport of newborns from hospital to home. METHODS: We interviewed parents of newborn infants, using a structured questionnaire, at the time of their discharge from Cheil General Hospital & Women's Health Care Center, between May 2014 and July 2014. RESULTS: A total of 403 participants were interviewed. The rate of CSS use was only 14.9%. Overall, 76.4% of the families interviewed were not aware about the recommendations on CSS use for newborns when travelling in a car. The provision of education on using CSS significantly influenced their rate of use. Parents who were educated about mounting the CSS in a car used it more as compared with others (25.7% vs. 12.2%) (P=0.002). Furthermore, if parents had heard about the importance or necessity of CSS, they used it more than others did (19.5% vs. 10.6%, P=0.032). CONCLUSION: Despite the legal regulation, most parents transport their newborn infants without a CSS while traveling from hospital to their home. The rate of CSS use was influenced by parental education and their knowledge about its necessity. Education programs for parents must be reinforced to increase the CSS use.

Sudden unexpected cardio-respiratory arrest after venipuncture in children.

PURPOSE: This study aimed to investigate the clinical and socioenvironmental characteristics of sudden cardiorespiratory arrest after venipuncture in children. METHODS: We conducted a retrospective email-based survey of all members of the Korean Pediatric Society. The questionnaire included items on patient demographics, socioenvironmental circumstances of the venipuncture, type of cardiorespiratory arrest, symptoms and signs, treatment, prognosis, and presumed cause of the arrest. RESULTS: Fourteen patients were identified. Of these, 13 were young children (<2 years old), and 1 was 14 years old. All patients had been previously healthy and had no specific risk factors for sudden cardiorespiratory arrest. Most cases (n=11, 79%) were defined as cardiac or cardiorespiratory arrest, while the remaining cases (n=3, 21%) were defined as respiratory arrest. Aspiration (n=3), acute myocarditis (n=2), and laryngeal chemoreflex (n=1) were presumed as the causes; however, the exact causes were unclear. The overall prognosis was poor (death, n=7; morbidity, n=5; full recovery, n=2). The medical institutions faced severe backlash because of these incidents (out-of-court settlement, n=5; medical lawsuit, n=5; continuous harassment, n=3). CONCLUSION: Cardiorespiratory arrest after venipuncture is unpredictable and the probable cause of most cases is a vasovagal reaction. Medical personnel must be aware of the risk of unexpected cardiorespiratory arrest during routine intravenous procedures.

Maternal food restrictions during breastfeeding.

PURPOSE: This study investigated self-food restriction during breastfeeding, reviewed the literature showing the effect of maternal diet on the health of breast-fed infants, and explored the validity of dietary restrictions. METHODS: Questionnaire data were collected from breastfeeding Korean mothers who visited the pediatric clinic of Cheil General Hospital & Women's Healthcare Center from July 2015 through August 2015. The survey included items assessing maternal age, number of children, maternal educational attainment, household income, degree of difficulty with self-food restriction, types of self-restricted foods, dietary customs during breastfeeding, and sources of information about breastfeeding. RESULTS: The questionnaire was completed by 145 mothers. More than a third (n=56, 39%) had discomfort from and usually avoided 4-5 types of food (mean, 4.92). Mothers younger than 40 years had more discomfort (odds ratio [OR], 12.762; P=0.017). Primiparas felt less discomfort than multiparas (OR, 0.436; P=0.036). Dietary practices were not influenced by maternal educational attainment or household income. The most common self-restricted foods were caffeine (n=131, 90.3%), spicy foods (n=124, 85.5%), raw foods (n=109, 75.2%), cold foods (n=100, 69%), and sikhye (traditional sweet Korean rice beverage) (n=100, 69%). Most mothers (n=122, 84.1%) avoided foods for vague reasons. CONCLUSION: Most mothers restricted certain foods unnecessarily. Literature review identified no foods that mothers should absolutely avoid during breastfeeding unless the infant reacts negatively to the food.

Neonatal clavicle fracture in cesarean delivery: incidence and risk factors.

BACKGROUND: Neonatal clavicle fracture in cesarean delivery is rare and has not been extensively studied. METHODS: We performed a retrospective review of cesarean deliveries with neonatal clavicle fracture during a 12-year period. Maternal and neonatal factors as well as surgical factors related to cesarean delivery for the fracture were determined and compared to the control group to analyze their significance. RESULTS: Among a total 89 367 deliveries during the study period, 36 286 babies were born via cesarean section. Nineteen cases of clavicle fractures in cesarean section were identified (0.05% of total live births via cesarean section). In the analysis of maternal and neonatal risk factors, birthweight, birthweight ≥ 4000 g and maternal age were significantly associated with clavicle fracture in cesarean section. However, clavicle fractures were not correlated with the selected surgical factors such as indication for cesarean section, skin incision to delivery time and incision type of skin and uterus. Logistic regression analysis showed that birthweight was the major risk factor for clavicle fracture. CONCLUSION: Clavicle fractures complicated 0.05% of cesarean deliveries. The main risk factor related to a clavicle fracture in cesarean section was the birthweight of an infant. As reported in previous studies associated with vaginal delivery, clavicle fracture is considered to be an unavoidable event and may not be eliminated, even in cesarean delivery.

Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

PURPOSE: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). METHODS: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. RESULTS: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. CONCLUSIONS: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

Clinical features of Bednar's aphthae in infants.

PURPOSE: Although Bednar's aphthae are common and regress spontaneously, these lesions may lead to feeding intolerance and are often misdiagnosed, rendering examinations useless. This study sheds new light on the clinical features of Bednar's aphthae. METHODS: Sixteen neonates and infants were newly diagnosed with Bednar's aphthae via routine health check-ups in an outpatient clinic. Medical records were retrospectively reviewed, and the following parameters were analyzed; sex, gestational age, birth weight, mode of delivery, and perinatal problems. A physical examination was carried out during the next outpatient visit to examine the healing process and check for the existence of scars or complications. RESULTS: Initial presentation included changes in feeding habits (n=10), longer feeding time, reduced intake, and increased irritability. In 6 patients, Bednar's aphthae were discovered incidentally, without prior symptoms. Feeding posture and method of feeding are important causes of Bednar's aphthae. Eleven patients were fed in a horizontal position, whereas 5 patients were fed in a semiseated position. Fifteen patients were bottle-fed, whereas 1 patient was exclusively breastfed. After correcting the feeding position, the ulcerative lesions disappeared within 1 month of diagnosis. During the follow-up period, lesions did not recur in any of the patients. CONCLUSION: This study suggests that Bednar's aphthae are caused by mechanical pressure. A diagnosis of Bednar's aphthae should be considered when lesions are found on the palate of infants and when symptoms seem to be feeding related. Proper education of parents can both treat Bednar's aphthae and easily prevent its recurrence.

Effect of Prophylactic Palivizumab on Admission Due to Respiratory Syncytial Virus Infection in Former Very Low Birth Weight Infants with Bronchopulmonary Dysplasia.

The aim of this study was to observe the effects of prophylactic palivizumab on hospitalization secondary to respiratory syncytial virus (RSV) infection (RSVhospitalization) in former very low birth weight infants (VLBWI) with bronchopulmonary dysplasia (BPD). This study also sought to identify the risk factors of RSVhospitalizationin this particular infant population. A prospective observational study was conducted between September 2007 and April 2008 in seven Korean hospitals. Children with a history of very low birth weight, a diagnosis of BPD and who were <2 yr old at the onset of the RSV season were included in this study. Palivizumab injections were administered monthly for a maximum of five months during the RSV season. RSVhospitalization rates were reviewed, and RSVhospitalization rates between subgroups were categorized by gestational age, birth weight, and duration of ventilator care. A total of 90 subjects completed the follow-up interviews. The mean gestational age at birth was 26.1±1.7 weeks, and the mean birth weight was 889.4±222.2 g. The incidence of RSVhospitalization in the study population was 8.9% (8/90), and the mean hospital stay was 11.0±5.5 days, including one death. There were no statistically significant differences in the patients' demographic characteristics or risk factors for RSV hospitalization. When subgroup analyses were conducted, there were still no statistically significant differences. The administration of palivizumab prophylaxis during the entire RSV season is important in VLBWI with BPD, regardless of their gestational age and birth weight, or previous ventilator dependency.

Neonatal clavicular fracture: recent 10 year study.

BACKGROUND: The clavicle is the bone most frequently fractured during the delivery process. METHODS: A retrospective review was performed of all births with clavicular fractures from January 2003 to December 2012. Risk factors for fracture were determined and then compared to the control group. The data were compared and analyzed with previous studies. RESULTS: Three hundred and nineteen cases of clavicular fracture (0.41% of total live births, n = 77 543) were identified. Prior to discharge, 275 cases (86.2%) were detected, and 44 cases (13.8%) were not detected until after discharge. Physical examination identified 144 cases (45.1%), while 175 cases (54.9%) were identified on chest X-ray incidentally. All babies with fracture, including five (1.6%) with brachial plexus palsy, recovered without treatment. Vacuum delivery was associated with a significantly higher incidence of clavicular fracture, as were mothers of advanced age with relatively shorter height. High birthweight, low head to chest circumference ratio and low Apgar score were other variables also significantly associated with clavicular fracture. On logistic regression analysis vacuum delivery and birthweight were significant risk factors. When analyzing and comparing findings from previous studies, only birthweight was identified as common to the risk factors affecting clavicular fracture. CONCLUSION: Major risk factors for clavicular fracture were vacuum delivery and birthweight. Considering the previous studies together, neonatal clavicular fracture appears to be a transient event without sequelae and most probably not preventable during birth.

Usefulness of a rapid real-time PCR assay in prenatal screening for group B streptococcus colonization.

BACKGROUND: Group B streptococcus (GBS) infection is a leading cause of neonatal morbidity and mortality worldwide. Here, we present the analytical and diagnostic usefulness of a new real-time PCR-based assay (Xpert GBS; Cepheid, USA) for rapid and accurate prenatal GBS screening. METHODS: We enrolled 175 pregnant women who were between 35 and 39 weeks of gestation. The analytical performance of the Xpert GBS assay was first tested using a reference GBS strain. Next, to test diagnostic performance, rectovaginal swabs were obtained from pregnant women who visited the hospital for regular antenatal screening after 34 weeks of gestation. The results of the Xpert GBS assay were compared to those of standard culture for the detection of prenatal GBS colonization. RESULTS: When any positive result from Xpert GBS or culture was considered a true positive, the sensitivity of the Xpert GBS assay and culture were 91% (20/22; 95% CI [confidence interval], 72-98) and 68% (15/22; 95% CI, 47-84), respectively. The specificity of both methods was 100% (153/153; 95% CI, 97-100). The sensitivity and specificity of the Xpert GBS assay, using the culture results as a reference, were 86.7% and 95.6%, respectively. In the Xpert GBS assay, the median threshold cycle of vaginally colonized samples was significantly lower than rectally colonized samples (P<0.01). CONCLUSIONS: The Xpert GBS assay is an accurate, rapid, easy-to-use test for the detection of maternal GBS colonization in prenatal screening that might be especially useful in clinical settings where standard culture is not feasible.

A case report on 30-week premature twin babies with congenital myotonic dystrophy conceived by in vitro fertilization.

Congenital myotonic dystrophy type 1 (DM1) presents severe generalized weakness, hypotonia, and respiratory compromise after delivery with high mortality and poor prognosis. We presented a congenital DM1 of premature twins in the 30th week of gestation. These twins were conceived by in vitro fertilization (IVF). Both babies presented apnea and hypotonia and had characteristic facial appearance. They were diagnosed DM1 by genetic method. They were complicated by chylothorax and expired at 100 and 215 days of age, respectively. Mother was diagnosed DM1 during the evaluation of babies. This is the first report on congenital DM1 which accompanied the chylothorax. More investigation on the association with chylothorax and congenital DM1 is recommended. With a case of severe neonatal hypotonia, congenital DM1 should be differentiated in any gestational age. Finally, since DM1 is a cause of infertility, we should consider DM1 in infertility clinic with detailed history and physical examination.

Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study.

Rotavirus (RV) infection is the primary cause for childhood gastroenteritis worldwide. In Korea, RV infection is most common among children less than 5 years of age. This post-licensure study was conducted to further evaluate the RV vaccine (RIX4414) to provide additional local clinical data to the Korean Food and Drug Association. Healthy infants aged 6-12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0, 1-2 month schedule. Blood samples were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA. Gastroenteritis stool samples were tested for the presence of RV using ELISA. RV positive samples were subjected to further analysis for G and P typing. Among 684 infants enrolled and vaccinated, 432 infants (RIX4414=318; placebo=114) were included in the according-to-protocol cohort for immunogenicity. The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1% (95% CI: 84.0-91.4) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml (95% CI: 174.2-249.5). Occurrence of solicited and unsolicited adverse events were similar in both, RIX4414 and placebo groups. None of the gastroenteritis stool samples tested positive for RV and no fatal SAEs were reported in either groups. The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared to the placebo group, when administered to healthy Korean infants.