Longitudinal changes in attachment patterns of preterm infants born in a non-Western country.

Unexpected early birth of an infant may affect the attachment formation of mother-child dyads. This longitudinal study aimed to explore mother-infant attachment patterns of very preterm (VPT) and preterm (PT) infants compared to their term-born peers in a non-Western country. Neurodevelopmental outcomes of infants, maternal anxiety and depressive symptoms, and sociodemographic features were evaluated to explore their effects on attachment. Eighteen VPT, 11 PT, 11 term infants and their mothers participated. Observations of attachment patterns and neurodevelopmental assessments were performed at 18 and 24 months of corrected age. This study identified a change in attachment patterns of VPT infants over time such that VPT infants tended to have less insecure attachment patterns with their mothers at the end of the infancy period. While motor and language development scores were associated with attachment patterns at 18 months, models predicting attachment patterns were no longer significant at 24 months. Therefore, change in VPT infants' developmental outcomes and attachment patterns over time suggests that preterm birth itself is not necessarily a risk factor for developing insecure attachment patterns; yet, developmental delays may account for insecure attachment patterns. It is suggested that efforts to promote developmental outcomes of preterm infants may improve mother-child attachment.

El inesperado nacimiento prematuro de un infante pudiera afectar la formación de la afectividad de las díadas madre-niño. Este estudio longitudinal se propuso explorar los patrones de afectividad madre-infante de infantes nacidos muy prematuramente (VPT) e infantes prematuros (PT) comparados con sus compañeros nacidos dentro del término regular en un país no occidental. Se evaluaron los resultados de desarrollo neurológico de los infantes, la ansiedad y síntomas depresivos maternos, así como las características socio-demográficas, con el fin de explorar sus efectos sobre la afectividad. Dieciocho VPT 11 PT, 11 infantes nacidos dentro del término regular y sus madres participaron. Las observaciones de patrones de afectividad y evaluaciones de desarrollo neurológico se llevaron a cabo a los 18 y 24 meses de la edad corregida. Este estudio identificó un cambio en los patrones de afectividad de los infantes VPT a lo largo del tiempo, de tal manera que los infantes VPT tendieron a tener menos patrones de afectividad insegura con sus madres al final del período de infancia. Mientras que los puntajes de desarrollo motor y de lenguaje se asociaron con patrones de afectividad a los 18 meses, los modelos que predijeron los patrones de afectividad ya no eran significativos a los 24 meses. Por tanto, el cambio en los resultados de desarrollo de los infantes VPT y los patrones de afectividad a lo largo del tiempo sugieren que el nacimiento prematuro en sí no es necesariamente un factor de riesgo para desarrollar patrones de afectividad insegura, pero los retardos en el desarrollo pudieran ser responsables de patrones de afectividad insegura. Se sugiere que los esfuerzos para promover los resultados de desarrollo de infantes prematuros pudieran mejorar la afectividad madre-niño.

Unexpected early birth of an infant may affect the attachment formation of mother-child dyads. This longitudinal study aimed to explore mother-infant attachment patterns of very preterm (VPT) and preterm (PT) infants compared to their term-born peers in a non-Western country. Neurodevelopmental outcomes of infants, maternal anxiety and depressive symptoms, and socio-demographic features were evaluated to explore their effects on attachment. Eighteen VPT, 11 PT, 11 term infants and their mothers participated. Observations of attachment patterns and neurodevelopmental assessments were performed at 18 and 24 months of corrected age. This study identified a change in attachment patterns of VPT infants over time such that VPT infants tended to have less insecure attachment patterns with their mothers at the end of the infancy period. While motor and language development scores were associated with attachment patterns at 18 months, models predicting attachment patterns were no longer significant at 24 months. Therefore, change in VPT infants' developmental outcomes and attachment patterns over time suggests that preterm birth itself is not necessarily a risk factor for developing insecure attachment patterns; yet, developmental delays may account for insecure attachment patterns. It is suggested that efforts to promote developmental outcomes of preterm infants may improve mother-child attachment.

Developmental and behavioral outcomes of preschool-aged children with biotinidase deficiency identified by newborn screening.

Biotinidase deficiency (BD) may cause neurological symptoms and developmental problems. However, newborn screening of BD and early biotin treatment prevent the manifestation of the majority of symptoms. This study intended to examine the developmental and behavioral outcomes as well as maternal anxiety and depressive symptoms of preschool-aged children with BD and to compare these with the outcomes of healthy preschool-aged children. In total, 49 children with BD and 23 healthy children are included. All children were screened for developmental and behavioral problems. Moreover anxiety and depressive symptomatology of their mothers were evaluated. Despite the high percentage of developmental delay in BD group, the numbers of children screened positive for a developmental delay were statistically similar in children with BD and healthy children. Among patients with BD, children with risk of developmental delay had more unfavorable socio-demographic features compared to typically developing ones. Behavioral problem scores, maternal anxiety, and depressive symptoms scores of children with BD were not higher than the healthy children.Conclusion: Children with BD were not different from their healthy peers in terms of developmental and behavioral outcomes. Developmental problems of children with BD may be related to the unfavorable socio-demographic features, not the BD itself. What is known: • Biotinidase deficiency (BD) may result in neurological symptoms and developmental problems. • Newborn screening and early biotin supplementation prevent the manifestation of the majority of symptoms. What is new: • Preschool-aged children with BD identified by newborn screening are not different from their healthy peers in terms of developmental and behavioral outcomes. • Maternal anxiety and depressive symptoms scores of children with BD are similar to scores of healthy children.

Preterm birth and maternal sensitivity: Findings from a non-western country.

INTRODUCTION: Although there are several studies on maternal sensitivity of preterm-born children conducted in Western countries, the factors affecting the sensitivity of mothers of preterm infants have not been investigated outside the Western context. OBJECTIVES: This study aimed to compare maternal sensitivity of preterm children at 18 months of corrected age with their healthy term-born peers and explore the factors associated with maternal sensitivity in a middle-income non-Western country. Moreover, the associations of maternal sensitivity with socio-demographic factors, maternal depression, and social-emotional competency and behavior problems of infants were investigated. METHODS: In total, 70 (40 preterm-born and 30 term-born) mother-child dyads participated in this study. An observation-based measurement tool, Maternal Sensitivity Scale, was used to assess maternal sensitivity. Social-emotional competency and behavior problems of infants were evaluated via The Turkish version of the Brief Infant-Toddler Social Emotional Assessment. Maternal depressive symptoms were assessed via the Beck Depression Inventory. In addition, a demographic information form was filled out by the mothers. RESULTS: Maternal sensitivity scores of preterm infants were significantly lower compared to term infants. Depressive symptoms scores and employment status of mothers, socio-economic status (SES), gestational age, breastfeeding duration, and behavior problems of children were the factors related to maternal sensitivity scores. In hierarchical regression analysis, SES and gestational age were the strongest predictors of maternal sensitivity. After controlling SES and gestational age, maternal depressive symptoms scores negatively predicted maternal sensitivity scores. CONCLUSION: This study pointed out the factors associated with the maternal sensitivity of preterm infants outside the Western context. Interventions to improve sensitive parenting behaviors of preterm infants are needed, especially in socio-economically disadvantaged groups.

Developmental and behavioral problems in preschool-aged primary ciliary dyskinesia patients.

Primary ciliary dyskinesia (PCD) causes a broad spectrum of disease. This study aims to explore the developmental, behavioral, and social-emotional aspects of preschool-aged children with PCD. Fourteen PCD, 17 cystic fibrosis (CF) patients and 15 healthy subjects were enrolled. Developmental features of the participants were evaluated with Ages and Stages Questionnaire. Parents of participants filled out the Child Behavior Checklist (CBCL). The number of children screened positive for developmental delay was statistically higher in the PCD group. Higher numbers of children with PCD were screened positive for developmental delay in communication and problem-solving domains. Delay in fine motor skill domain was more common in children with PCD and CF compared to healthy subjects. There was no difference among the three groups in terms of gross motor and personal-social development. None of the children in all three groups was shown to have social-emotional problems. In CBCL, patients with CF had higher internalizing problem scores. Externalizing and total problem scores did not differ between the three groups. However, among PCD patients, children with developmental delay on more than one domain had higher externalizing and total problem scores.Conclusion: The current study revealed that positive screening for developmental delay is more common in preschool-aged PCD patients compared to patients with CF and healthy children. What is Known: • Intelligence scores of school-aged PCD patients are similar to healthy subjects despite their higher internalizing problem scores on Child Behavior Checklist (CBCL). • School-aged PCD patients exhibit higher hyperactivity and inattention findings. What is New: • Positive screening for developmental delay in communication, problem-solving and fine motor skills is more common in preschool-aged PCD patients. • Preschool-aged PCD patients screened positive for developmental delay in more than one domain have higher externalizing and total problem scores on CBCL.

Vitamin A supplementation in acute diarrhea.

BACKGROUND: Vitamin A supplementation reduces the severity of subsequent diarrheal episodes. This study was conducted to examine the effect of single oral high-dose vitamin A supplementation on the duration of acute diarrhea in 6- to 12-month-old infants who are not malnourished. METHOD: In this double-blind, randomized, placebo-controlled study, infants who were admitted to Hacettepe University Ihsan Dogramaci Children's Hospital Diarrheal Diseases Training and Treatment Unit with acute diarrhea were randomly assigned either to a group receiving a single oral dose of 100,000 IU vitamin A or placebo. There were 60 infants in each group. All infants were followed up until the diarrheal episode ended. Serum vitamin A levels were determined both at admission and 2 weeks later. RESULTS: No effect of vitamin A supplementation could be demonstrated on either the total duration of diarrhea (7.4 +/- 3.2 days in the treatment group vs. 7.8 +/- 3.1 days in the placebo group) or on its duration after intervention (3.8 +/- 2.3 days in the treatment group vs. 3.9 +/- 1.9 days in the placebo group; P > 0.05 for both comparisons). Serum vitamin A levels were not significantly different at admission (23.5 +/- 9.7 microg/dL in the treatment group vs. 24.1 +/- 9.7 microg/dL in the placebo group; P > 0.05) nor at the end of a follow-up period of 2 weeks (treatment: 33.3 +/- 13.7 microg/dL, placebo: 35.2 +/- 11.2 microg/dL; P > 0.05). However, the increase in serum vitamin A levels at the end of the 2-week follow-up interval for infants in both the treatment and placebo groups were found to be significant compared with levels at admission (P < 0.01). The mean weight gain in both groups were similar by the end of the first month (6.9 +/- 5.0% in the treatment group vs. 6.3 +/- 4.2% in the placebo group; P > 0.05). CONCLUSION: No effect of oral vitamin A supplementation on serum vitamin A levels, duration of diarrhea, or weight gain during an acute diarrheal episode could be demonstrated in our study group of infants between 6 and 12 months of age who had no malnutrition.

Short-term developmental outcome of iron prophylaxis in infants.

BACKGROUND: Previous studies on the cognitive effects of iron treatment have focused on anemic or non-anemic iron-deficient infants. The effect of iron supplementation on cognitive development among iron-sufficient infants has not been studied. The aim of the present study was to examine the effect of iron supplementation on performance in the Bayley Scales of Infant Development (BSID) and anthropometric measurement in 6-month-old iron-sufficient healthy infants. METHODS: Healthy, iron-sufficient infants who were 6 months of age and were attending the Well Baby Clinic were considered for enrollment. Infants were randomly assigned to take ferrous sulfate supplementation (1 mg/kg per day) or no supplementation and were followed for 3 months. Anthropometric measurement, hematologic status and BSID were evaluated on admission and after 3 months. RESULTS: Seven infants in the intervention group and nine in the control group completed the study. No significant differences were observed in anthropometric measurements and complete blood counts between the two groups after the 3 month study period. The mean transferrin saturation (TS) level decreased significantly in the control group during the study period (from 15.3+/-2.6 to 7.8+/-5.1%; P = 0.0117), but no such reduction was seen in the intervention group. At the end of the study, the TS of the control group was found to be significantly lower than that of the intervention group (7.8+/-5.1 vs. 19.9+/-7.9%, respectively; P = 0.0033). The BSID scores of infants in both groups were within the normal range on admission and at the end of the study period. CONCLUSIONS: Short-term iron supplementation did not change developmental test scores despite the hematologic response in iron-sufficient healthy infants. The high prevelance of iron-deficiency anemia and its relationship with adverse developmental outcome suggests that prevention of iron-deficiency anemia with prophylaxis needs to be emphasized, rather than treatment.

Safety and immunogenicity of live attenuated varicella vaccine in 9-month-old children.

BACKGROUND: The present study was conducted to evaluate the safety and immunogenicity of live attenuated varicella vaccine (Oka-strain) in 9-month-old infants. METHODS: One hundred and fourteen infants were vaccinated once with live attenuated varicella vaccine (Valrix; SmithKline Beecham Biologicals, Rixensart, Belgium) containing a mean virus titer of 10(4.0) plaque-forming units (p.f.u.) per dose. Signs and/or symptoms after vaccination were followed for 42 days. Home visits were made to detect solicited local reactions (0-3 days) and solicited general reactions (0-21 days), as well as unsolicited reactions. Specific varicella antibodies were determined by an indirect immunofluorescence method. The geometric mean titer and seroconversion rate were calculated. RESULTS: Signs and/or symptoms were reported in 47.4% (54/114) of cases following vaccination. The only local symptom reported was pain on digital pressure at the injection site and this was reported in 28.1% (32/114) of infants. General symptoms were reported in 38.6% (44/114) of cases. The most frequently reported findings were fever (27.2%), which was mostly mild, restlessness (20.2%) and cough (11.4%). Only four unsolicited symptoms were reported and they were all unrelated to vaccination. No serious adverse event was reported. Of the 109 infants included in the immunogenicity analysis, 105 were seronegative and four were seropositive for antibodies against varicella before vaccination. The vaccine elicited seroconversion in 97.1% of initially seronegative cases. The post-vaccination geometric mean titer for these infants was 30.9 geometric mean titer (GMT). CONCLUSIONS: The vaccine was found to be safe and immunogenic when given to infants as young as 9 months of age. This may be of clinical significance during outbreaks of varicella and especially for developing countries.

Reactogenicity and immunogenicity of a new measles-mumps-rubella vaccine containing RIT 4385 mumps virus strain in healthy Turkish children.

A total of 44 children aged between 15-18 months were randomly vaccinated either with a new measles-mumps-rubella (MMR) vaccine (Priorix, SmithKline Beecham) or a commercially available MMR vaccine (MMR-II, Merck) to compare the reactogenicity and immunogenicity. No local symptoms or fever was reported. Seroconversion rates of the study vaccine were 100, 95 and 100 percent for measles, mumps and rubella, respectively. The seroconversion rates for the control vaccine were 100, 94.7 and 95.5 percent, respectively. The geometric mean titers (GMT's) for the study and control groups were 1695, 95, 58; and 2198, 1183 and 47; respectively. In conclusion, the new MMR vaccine containing RIT 4385 mumps strain derived from the Jeryl Lynn strain was shown to be immunogenic and safe in healthy Turkish children. Further post-marketing surveillance should be conducted.

Immunogenicity study of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine used to reconstitute a freeze-dried Haemophilus influenzae type b vaccine (DTaP-IPV//PRP-T) administered simultaneously with a hepatitis B vaccine at two, three and four months of life.

This study was designed to assess the immunogenicity of a vaccine combining diphtheria and tetanus toxoids, acellular pertussis vaccine, and inactivated poliovirus vaccine reconstituting Haemophilus influenzae type b polysaccharide conjugated to tetanus protein (DTaP-IPV//PRP-T; Pasteur Mérieux Connaught, Lyon, France) administered simultaneously in association with hepatitis B vaccine (RECOMBIVAX (¿trade mark omitted¿) Merck, Sharp & Dohme, West Point, PA, USA) for the primary immunization of infants. The vaccines were administered at two, three and four months of age. One hundred and sixty-two healthy infants, aged 8-10 weeks, were enrolled in the study. Blood samples were taken before the first dose and 4 weeks after the third dose. The infants were observed for 15 minutes after vaccination for any immediate reaction. Adverse events requiring a medical consultation were recorded by the parents in a diary over the 7 days following vaccination. Four weeks after the third immunization, the percentages of infants fulfilling seroconversion criteria were 98.9% for pertussis toxin, 95.9% for filamentous haemagglutinin, 100.0% for tetanus, 100.0% for diphtheria, 99.3% for poliovirus type 1, 100.0% for both poliovirus types 2 and 3, 98.0% for Haemophilus influenzae type b, and 100% for hepatitis B surface antigen. No vaccine-related serious adverse event was reported. The simultaneous administration of DTaP-IPV//PRP-T and hepatitis B vaccines at two, three and four months of age yielded clinically satisfactory immune responses to all antigens compared with historical controls and gave a good safety profile.

Clinical characteristics of transient glucose intolerance during acute diarrhoea.

Transient glucose intolerance (TGI) is an important cause of WHO G-ORS (Glucose-Oral Rehydration Solution) treatment failure and hospitalization in dehydrated children during acute diarrhoea. This retrospective case-control study was designed to determine some risk and predictive factors for developing TGI among moderately dehydrated patients with acute diarrhoea while under G-ORS therapy. Among moderately dehydrated patients, files of 22 patients with TGI and 66 other dehydrated patients without intolerance were reviewed. Patients with TGI were younger (9.7+/-10.5 mo and 11.6+/-7.8 mo, respectively, p < 0.05), the median age being 6 mo in the TGI group and 10 mo in non-TGI group. There was no difference between groups for sex, admission season, history of fever or vomiting, frequency of vomiting, presence of blood, mucous or leukocyte in stool, presence of associated disease and duration of diarrhoea on admission. The admission haemoglobin, white blood cell, blood pH, sodium and potassium levels were similar in both groups. The mean serum chloride level (116.8+/-6.9, 109.6+/-7.9 mEq/l, respectively, p<0.05) was higher in the TGI group and the bicarbonate level was lower (12.9+/-3.8, 15.3+/-6.0, respectively, p < 0.05). Stool frequency was also higher in patients with TGI (11.2+/-5.3/24 h, 5.9+/-4.4/24 h, respectively, p < 0.05). No difference was found between the nutritional status of children in both groups. More children were breastfed in the group without TGI (34/56, 61%, 6/18, 33% respectively, p=0.079, OR=0.32, 95% CI [0.09-1.11]). It was concluded that patients with TGI are younger and have high stool frequency. Although statistical significance could not be shown, breastfeeding seems to protect children from TGI, as it protects from diarrhoea.

Rehydration of moderately dehydrated children with transient glucose intolerance using rice oral rehydration solution.

Following the successful rehydration of two moderately dehydrated patients with transient glucose intolerance (TGI) using rice-oral rehydration solution (R-ORS), R-ORS has been used in Hacettepe University Ihsan Dogramaci Children's Hospital Diarrhea Training and Treatment Unit (DTTU) to rehydrate moderately dehydrated children with TGI. The files of children with moderate dehydration and glucose intolerance admitted to the unit were reviewed retrospectively within two periods according to the availability of R-ORS. The clinical and laboratory findings were analysed where available. Before R-ORS became available (September 1993) 6 patients were admitted, all of whom deteriorated with glucose (G)-ORS treatment in 7.0 +/- 3.8 h and were hospitalized for i.v. fluid treatment. During the second period 22 moderately dehydrated children with TGI were admitted. The clinical and laboratory characteristics on admission of the children in the two periods were not statistically different (p > 0.05). Among the 22 patients admitted during the second period 10 were administered G-ORS in the unit and 12 had already received G-ORS at home. Clinical and laboratory deterioration was observed in these 10 patients while receiving G-ORS in the unit within 6.3 +/- 3.7 h and rehydration was continued with R-ORS. Clinical and laboratory improvement were demonstrated in 8 patients within 18.2 +/- 6.5 h. Overall, 17 patients were rehydrated successfully with R-ORS, with a mean time of 18.0 +/- 7.2 h. Five patients were hospitalized. The overall success rate of R-ORS was 77.3%. R-ORS may be considered as an alternative mode of therapy to i.v. treatment in the rehydration of moderately dehydrated children with TGI.

Priming effect, immunogenicity and safety of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-acellular pertussis (DTaP) combination vaccine administered to infants in Belgium and Turkey.

To evaluate the priming effect, immunogenicity and safety of an Haemophilus influenzae type b (Hib) tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-acellular (two component) pertussis (DTaP) combination vaccine, a randomized, comparative study was conducted in two centers, one in Belgium and one in Turkey. A total of 410 healthy infants, 160 in Belgium and 250 in Turkey, randomly received DTaP and PRP-T vaccines in one of three fashions. One group (N = 138) received DTaP and PRP-T vaccines reconstituted immediately prior to injection at 3, 4 and 5 months of age, and are referred to as the combined, short schedule group (Co-S). A second group (N = 135) received DTaP + PRP-T simultaneously but injected at different sites according to the same schedule, and are referred to as the associated, short schedule group (As-S). The third group (N = 137) also received DTaP + PRP-T at separate sites, but at 2, 4 and 6 months, and are referred to as the associated, long schedule group (As-L). The As-L group allowed for serological bridging with a Senegalese two-component pertussis vaccine efficacy trial, using the same batch of DTaP vaccine. Children of both short-schedule groups (Co-S and As-S) received, at the age of 12-14 months, a booster dose of DTaP vaccine associated with unconjugated PRP vaccine. Mixing of the vaccines did not affect the immune response to the antigens included in the DTaP vaccine. The immune response to Hib capsular polysaccharide, however, was significantly lower after combined administration (Co-S group) than after associated (As-S group) administration (P < 0.0001), with a similar trend among both countries (GMTs, 1.78 microg/ml and 6.19 microg/ml in Belgium, and 5.02 microg/ml and 11.67 microg/ml in Turkey). Booster vaccination with the unconjugated PRP induced a vigorous and similar anamnestic response in both groups. Belgian infants showed a significantly lower immune response to all antigens than Turkish infants (P < or = 0.001 for all antigens), with a similar trend among each study group. In all groups, the incidence of adverse events was lower than that usually reported after DTwP(whole-cell) vaccine. Higher rates of systemic reactions were observed in the Belgian population, possibly due to differences in reporting practice. Our results indicate (1) that the combination vaccine, DTaP//PRP-T, represents an important improvement over the existing uncombined vaccines; (2) that immunogenicity studies should include at least one booster injection to evaluate priming effects by combined vaccines; and (3) that it is feasible and valuable to co-randomize combination vaccine studies in sufficiently different geographical areas and child populations.

Primitive neuroectodermal tumor of the orbit in an adult. A case report and literature review.

OBJECTIVE: The authors describe the salient clinical, radiologic, and histopathologic features of an orbital primitive neuroectodermal tumor in a 28-year-old man. This is an extremely rare tumor of the orbit, previously reported exclusively in children. DESIGN: Case report. INTERVENTION: Excisional biopsy of the tumor en bloc was performed. MAIN OUTCOME MEASURES: Histopathologic examination was performed by standard techniques and immunohistochemical stains on formaldehyde-fixed, paraffin-embedded tumor tissues. RESULTS: Histologic examination of the sections of the tumor showed small, blue, round cells with occasional Homer-Wright rosette formations. The tumor cells stained positively with neuron-specific enolase and vimentin. CONCLUSIONS: This newly recognized, highly unusual peripheral primitive neuroectodermal tumor should be considered in the differential diagnosis of hypercellular, small, round cell tumor of the orbit in adults.

Safety, tolerability and immunogenicity of a Haemophilus influenzae type b vaccine containing aluminum phosphate adjuvant administered at 2, 3 and 4 months of age.

The primary aim of this study was to assess the tolerability and immunogenicity of a new Haemophilus influenzae type b (Hib)/AlPO4 (CHIRON, SpA) vaccine, in two-month-old healthy infants. Twenty-three subjects were enrolled and administered the new Hib vaccine containing AlPO4 adjuvant at two, three and four months of age concomitantly with diphtheria-pertussis-tetanus (DPT) and hepatitis B vaccines according to the local program. Children were observed for 30 minutes after each immunization for any immediate local and systemic reactions. An active surveillance for side effects was performed on the 2nd and 7th days following each immunization by telephone. Families also filled out diaries for the first seven days. From the 2nd day to the next immunization only data about adverse events necessitating a physician's visit or about serious adverse events were collected. Blood samples were obtained before the first immunization and one month after the third dose for evaluation of anti-polyribosylribitol phosphate (PRP) antibody response. Local reactions at the Hib site were mild and less frequent compared to those observed at the DPT site. Systemic reactions noted after the three immunizations were fever in 70 percent, irritability in 48 percent, persistent crying in 26 percent, change in eating habits in 22 percent, diarrhea in 17 percent, sleepiness in 17 percent, vomiting in 9 percent, and unusual crying in 4 percent of the cases. There was no serious adverse event. One hundred percent and 95 percent of children achieved an anti-PRP antibody response over 0.15 microg/ml and 1.0 microg/ml, respectively. The geometric mean titer was 15 microg/ml and the geometric mean ratio 84. It was concluded that the new (Hib)/AlPO4 vaccine is safe and well tolerated, and induced a good PRP antibody response in healthy two-month-old infants.

Experience with oral rehydration therapy in moderately dehydrated children due to diarrhea.

Additional reports on oral rehydration therapy (ORT) in the management of moderately dehydrated patients may convince practitioners to convert from high-cost intravenous treatment to low-cost and efficient ORT in moderately dehydrated patients. Therefore, the failure rate and its association with admission serum sodium, potassium and bicarbonate levels of 162 moderately dehydrated children with diarrhea treated with ORT were analyzed retrospectively. The overall failure rate was found to be 17.6 percent. This rate did not differ significantly among normonatremic, hyponatremic and hypernatremic patients (16%, 25% and 28%, respectively; p > 0.05), nor did the rate differ among normokalemic, hypokalemic and hyperkalemic patients (16%, 33% and 25%, respectively; p > 0.05). Only moderately and severely acidotic patients had higher failure rates than non-acidotic and mildly acidotic cases (21%, 38%, 4% and 14% respectively; p < 0.05). Severely acidotic patients were also rehydrated over a longer time (10.4 +/- 6.6 hours) than were nonacidotic patients (6.7 +/- 2.3 hours, p < 0.001). Thus the degree of acidosis, which is closely related to the clinical severity of dehydration, was found to be much more predictive of ORT failure and the duration of rehydration than were other electrolyte disturbances. Besides correcting dehydration, ORT was safe and effective in treating various electrolyte disturbances.

Immunogenicity and safety of Haemophilus influenzae type b capsular polysaccharide tetanus conjugate vaccine (PRP-T) presented in a dual-chamber syringe with DTP.

Separate injections of Haemophilus influenzae type b capsular polysaccharide-tetanus conjugate (PRP-T) vaccine and diphtheria-tetanus-pertussis (DTP) reconstitution of freeze-dried PRP-T vaccine with liquid DTP vaccine have been shown to be safe and immunogenic in infants. The present study was conducted to test the safety and immunogenicity of the liquid combination vaccine administered to young infants in the dual-chamber syringe. The study was a monocenter, open clinical trial of 3 month-old infants receiving PRP-T and DTP vaccines in the dual-chamber syringe reconstituted prior to injection. Healthy infants were immunized according to a 3, 4 and 5 months-of-age schedule. The vaccine was administered in a dual-chamber syringe, ready to use with two chambers. The proximal chamber contained freeze-dried PRP-T and the distal chamber contained liquid combination-vaccine DTP. The freeze-dried PRP-T vaccine was reconstituted with the liquid DTP vaccine in the same unidose dual-chamber syringe (0.5 mL) and was injected intramuscularly into the deltoid region. Blood sampling was performed prior to vaccination at 3 months of age and after the third vaccination at 6 months. The primary end-point was the serological response to PRP-T vaccine as expressed by the percentage of infants with an antibody titer greater than or equal to 1 microgram/mL. The reactogenicity was expressed as the percentage of reported local and systemic reactions. A total of 108 infants were included in the study and received the dual-chamber syringe vaccine. After the third injection, all the infants had a PRP antibody titer greater than or equal to 0.15 microgram/mL and 94.4% of infants had a PRP antibody titer greater than or equal to 1 microgram/mL; the pertussis agglutinin titers were over the threshold 40 and 80 in all infants and 98.1% were over the threshold 320. After the third injection, all the infants had diphtheria antibody titers greater than 0.1 IU/mL and 83.3% had titers greater than 1 IU/mL; all the infants had tetanus antibody titers greater than 0.1 IU/mL and 97.2% had results over 1 IU/mL. Thirty-seven infants (34.6%) had local reactions and 64.5% had systemic reactions. The dual-chamber syringe may reduce the cost of vaccine delivery, as well as the workload, and increase the vaccine acceptability and coverage rate of vaccines.