Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with Acute Otitis Media (AOM).

Acute Otitis Media (AOM) is the most frequent respiratory tract infection of infancy and childhood that is treated with antimicrobial agents. The most common causative pathogens include Streptococcus pneumoniae, Hemophilus influenzae and Moxarella catarrhalis, and therefore antibacterial management should target against these isolates. Cefaclor, a congener of cephalexin monohydrate, is a semisynthetic cephalosporin antibiotic. It is an orally active cephalosporin which has demonstrated activity against a wide range of organisms in vitro. Present study is designed as a multicentric prospective trial to study and compare the efficacy and safety of cefaclor versus amoxicillin + clav in children with acute otitis media. One hundred and sixty seven patients were evaluated for efficacy endpoints in the cefaclor arm comprised of 104 males and 63 females with a mean age of 5.74+/-2.80 years and 185 patients in the amoxy-clav group comprised of 118 males and 67 females with a mean age of 4.93+/-2.92 years. Both cefaclor and amoxy-clav caused a significant improvement in all the signs and symptoms after a 10-day treatment period. However, between-the-group comparisons showed that the reduction in most of the symptoms was significantly more in cefaclor arm as compared to amoxicillin-clav arm. The clinical success (clinical cure + improvement) at the end of therapy was significantly more in cefaclor arm: 98% with cefaclor versus 85% with amoxicillin + clav, p<0.05 Table 3. Failure cases were prescribed other antibiotics according to the culture sensitivity reports, as rescue medication. Bacterial eradication rates were largely consistent with clinical responses. Bacteriological eradication was seen in 95% of patients in cefaclor group and 78% of patients in amoxicillin + clav group. In conclusion, cefaclor is a well tolerated and effective antibacterial option for acute otitis media in children and it is superior to the combination of amoxicillin + clav in efficacy and tolerability in acute AOM. Moreover, its expanded spectrum of activity, ability to achieve adequate concentrations in tissues, suitability for twice-daily dosing, and proven tolerability suggest that it is a good alternative to agents traditionally used in acute otitis media.

Childhood tuberculosis in a referral centre: clinical profile and risk factors.

One hundred and ninety six children (age group 6 months to 12 years) attending the Pediatric Tuberculosis Clinic at AIIMS, New Delhi, over a period from January 1988 to December 1989 were analysed. Nearly 61% of children were malnourished (Grades III and IV). A positive family history was noted in nearly one third (33.7%) of cases while 41.3% of children had received BCG. A positive Mantoux test was noted in 77% of cases. The most prominent lesion on radiology was parenchymal (51.4%). In nearly two third of cases, both Mantoux test and X-ray chest was positive. A family history of tuberculosis and BCG vaccination was significantly associated with positive Mantoux test (p < 0.01). Fever and cough in older children (> 6 years) while weight loss in younger children (< 3 years) were the predominant symptoms. Most of the cases (82.1%) had pulmonary primary complex, the proportion being higher in older age group. The severe form of tuberculosis, i.e., progressive primary disease, military tuberculosis, etc., were significantly more in younger children. The various risk factors significantly associated with severe form of tuberculosis were very young children (< 3 years), no BCG vaccination, a negative family history and a negative Mantoux test.

Prevention of hypoglycemia: a controlled evaluation of sugar fortified milk feeding in small-for-gestational age infants.

The study population included 110 term healthy small-for-gestational age (SGA) infants having a blood sugar of > 30 mg/dl at the age of < 30 minutes. They were randomized into two groups; (a) Group I (study group) received sugar-fortified milk formula and (b) Group II (control group) received standard milk formula. A minimum of 80 ml/kg/24 hour of milk was given. The first feeding was given within 45 minutes of birth and subsequently at 2 hours of age and then every 2 hourly till the age of 24 hours. The blood sugar (initial within 30 minutes of birth) was monitored at the age of 2, 4, 12 and 24 hours by dextrostix. The babies on fortified feeds received significantly (p < 0.001) higher amount of carbohydrate (8.1 mg/kg/min) as compared to those on standard milk (5.1 mg/kg/min). The incidence of hypoglycemia was reduced significantly (p < 0.01) by the sugar-fortified feeds. The mean blood sugar level in babies receiving fortified feeds was significantly higher at all the ages as compared to those receiving standard feeds. Nearly all the babies who subsequently developed hypoglycemia had a preceding blood sugar value of less than 60 mg/dl. The study highlights that sugar-fortified milk feeds are useful in preventing hypoglycemia in SGA infants and should be routinely recommended along with breast feeding in developing countries especially when facilities for monitoring of blood sugar are unsatisfactory or not available.

Spectrum of neonatal hyperbilirubinemia: an analysis of 454 cases.

A prospective study of 454 newborn babies with pathological hyperbilirubinemia revealed that in about one-third of cases (34.6%), no cause could be identified despite detailed investigations. Nearly three-fifth of infants (62.5%) had hyperbilirubinemia due to hemolytic causes. On the basis of four variables, i.e., peak serum bilirubin level, age of attaining the peak level, age of starting phototherapy and total duration of phototherapy, the cases of hyperbilirubinemia can be categorized into three groups: (a) Group I (mild) included non-hemolytic hyperbilirubinemia, i.e., idiopathic, bacterial infections, intrauterine infections and others, (b) Group II (moderate) comprised of hemolytic as well as non-hemolytic hyperbilirubinemia due to prematurity, administration of oxytocin, bruising/cephalhematoma, and (c) Group III (severe) comprised of hyperbilirubinemia due to hemolysis as a result of blood group incompatibility between the mother and the neonate and G-6-PD deficiency. Sixty six babies required exchange blood transfusion (EBT) and a total of 100 EBTs were performed. Most of the babies (80.3%) requiring exchange blood transfusion belonged to Group III. The most common cause of hemolytic hyperbilirubinemia needing exchange blood transfusion was Rh isoimmunization followed by G-6-PD deficiency and ABO isoimmunization. There was no death attributable to the procedure of exchange blood transfusion.

Neonatal hypoglycemia--clinical profile and glucose requirements.

A total of 2248 infants born at All India Institute of Medical Sciences Hospital, New Delhi were selectively screened for hypoglycemia over a period of 15 months. Hypoglycemia (blood glucose less than 30 mg/dl) was diagnosed in 107 cases (4.8%). Preterm babies had three times increased risk (12.8%) as compared to term babies (3.6%). Small-for-dates (SFDs) and large-for-dates (LFDs) infants were at increased risk of manifesting hypoglycemia (7 and 10 times, respectively) as compared to the appropriate-for-dates (AFDs) babies (2.7%). Approximately two-thirds of the hypoglycemic babies (67.3%) had one or more risk factors including birth asphyxia (24.2%), diabetic mothers (23.8%), respiratory distress (13.9%) and septicemia (11.6%). A total of 59.8% cases were asmyptomatic while the rest had one or more symptoms. The most common symptom observed was lethargy (81.4%), followed by jitteriness (67.4%), respiratory abnormalities (41.9%), hypotonia (39.5%) and seizures (30.2%). The amount of glucose (mg/kg/min) needed to maintain a stable blood sugar in various categories of hypoglycemic babies was observed to be in the following decreasing order of amount; symptomatic babies with seizures (Gp IV), IGDM's/IDM's and symptomatic babies with other features (Gp III), SFDs and LFDs (Gp II) and AFDs (Gp I). Such a categorization of hypoglycemic babies will help to treat them more precisely.

A controlled study of sugar-fortified milk feeding for prevention of neonatal hypoglycaemia.

Healthy term, large for gestational age (LGA) infants (130) with blood sugar greater than 30 mg/dl at the age of less than 30 min were randomized into two groups. Group I (study group) babies received sugar-fortified milk formula while group II (control group) received standard milk formula. Milk was fed at a minimum of 80 ml/kg/24 h. The first feed was given within 45 min of birth and subsequently at 2 h of age and then 2 hourly till the age of 24 h. The blood sugar (initial within 30 min of birth) was monitored by dextrostix at the age of 2, 4, 12 and 24 h. The babies on fortified feeds received significantly (P less than 0.001) higher amount of carbohydrate (8.2 mg/kg/min) as compared to those on standard milk (5.2 mg/kg/min). The incidence of hypoglycaemia was reduced significantly (P less than 0.05) by the sugar fortified feeds. The mean blood sugar level in babies receiving fortified feeds was significantly (P less than 0.001) higher at all ages as compared to those receiving standard feeds. Nearly all the babies who subsequently developed hypoglycaemia had an earlier blood sugar level of less than 60 mg/dl. The study shows that sugar-fortified milk feeds are useful in preventing hypoglycaemia in LGA infants and should be routinely recommended in the special care neonatal units of developing countries especially when facilities for monitoring blood sugar are unsatisfactory or unavailable.

Clinical profile of trichotillomania.

Twenty-four cases of trichotillomania attending psychiatry outpatient department and child guidance clinic at Kalawati Saran Children's and Smt Sucheta Kriplani Hospitals over a period of 2 years from July, 1985 to November 1987 were studied. Females (66.7%) outnumbered the males (33.3%). Majority of cases belonged to age group 6-10 years (54.2%) and nuclear family (68.5%). Nail-biting (25.0%) was the commonest associated neurotic trait, followed by enuresis (20.9%), temper-tantrum (12.5%), etc. A past history of hysterical fits and neurotic depression was found in 3 cases (12.5%) and 2 cases (8.3%) respectively. Family history of neurosis was seen in mothers and fathers of 20.9% and 12.5% cases respectively. Trichobezoars and trichophytobezoars were found in 6 cases (25.0%) and 3 cases (12.5%) respectively. Majority of patients of trichobezoars presented with vague complaints like heaviness in the stomach (55.6%), inability to gain weight (44.4%), etc, while 22.2% cases were asymptomatic and detected only on screening.

Maternal participation in the care of the high risk infant: follow-up evaluation.

Fifty mothers of high risk infants admitted to the Neonatal Special Care Unit were followed up to the postnatal age of 2.5 mo +/- 15 days. Twenty five mothers (Group I) had stayed in the nursery with the infant for a period of 4.8 +/- 4.6 days until the discharge of the infant, providing expressed milk and participating in the non-specialised care of the infant. The other 25 mothers (Group II) remained separate from their babies for the duration of the latter's stay in the hospital although some of the mothers did come off and on to give expressed human milk and at times handle their infants. Family features such as parental age, educational and occupational status, and presence of residential elder women, were similar in the two groups. Infant characteristics too, such as sex, birth weight, and early neonatal morbidity were also comparable. Operative deliveries and maternal problems were as expected more in the separated group. The duration of the infants' hospital stay was also more in the latter (9.5 +/- 3.5 vs 6.3 +/- 3.9 days; p greater than 0.05). Subsequent to their discharge, mothers who had stayed with the infant identified the following benefits of their stay--acquiring of knowledge relevant to infant care especially hygiene (19) and their personal involvement in the care of their infant (12), both of which they said increased their self confidence in looking after the babies after discharge, and provision of breast milk round the clock (17).(ABSTRACT TRUNCATED AT 250 WORDS)

Neurodevelopmental outcome of asymptomatic & symptomatic babies with neonatal hypoglycaemia.

A total of 107 babies with hypoglycaemia were studied over a period of 15 months. Symptomatic hypoglycaemia was found in 43 while it was asymptomatic in the others. Asymptomatic hypoglycaemia occurred at a relatively earlier post-natal age (4.5 +/- 2.2 h), as compared to symptomatic hypoglycemia (18.5 +/- 5.4 h, P less than 0.001). The mean blood glucose in hypoglycaemic babies with seizures was found to be significantly lower (P less than 0.001) when compared to those with other features as well as asymptomatic ones. Hypoglycaemia lasted for a significantly longer duration in symptomatic babies as compared to those without symptoms (P less than 0.001). On neurodevelopment follow up the mental developmental index (MDI) and the psychomotor developmental index (PDI) of symptomatic babies with seizures were significantly lower (P less than 0.001) as compared to those with other features of hypoglycaemia as well as asymptomatic babies. The neurodevelopmental status of babies with symptoms other than seizures was also significantly poorer (P less than 0.001), when compared to asymptomatic hypoglycaemic babies. The duration of hypoglycaemia was directly related to the MDI (r = -0.74, y = 102.5 - 0.69x) and PDI (r = -0.81, y = 105.6 - 0.86x). This study indicates that there is a need to identify babies vulnerable to symptomatic hypoglycaemia more precisely.

Breath holding spells: an analysis of 50 cases.

Of 50 preschool children having breath holding spells (M:F::3:1) (BHS), 80.0% were less than 18 months of age (mean age 16 +/- 5 mo). More children came from a lower social class (70.0%) and a nuclear family (64.0%). Seventy four per cent cases had onset of BHS within 12 months of age (mean 9.6 mo) and the commonest frequency was 1 to 3 spells per week (56.0%). Cyanosis and tonic-clonic spasms were seen in 96.0 and 84.0% cases, respectively. Anger and frustration were the common triggering factors in 90.0% cases. No ante-, peri- and postnatal factors were significantly associated with the study group as compared to the control cases. The mean scores on Behaviour Screening Questionnaire measuring child's habits related to feeding, toilet and sleep were not significantly different in the study and control groups but the difference was significant (p less than 0.05) for behaviour measuring child's social habits. Parental attitudes, measured on Attitude Screening Questionnaires, were also not significantly different in the study and control groups. Mean hemoglobin and percentage transferrin saturation were significantly lower in the study group as compared to the controls (p less than 0.001). There was a significant decrease in severity and frequency of spells with oral iron therapy.

Polycythemia in the newborn: do asymptomatic babies need exchange transfusion?

A total of 2288 infants were screened for hematocrit over a period of 15 months. Polycythemia was diagnosed in 27 cases (1.2%). Preterm and term babies had more or less equal risk to develop polycythemia (1.5% and 1.1% respectively) while postterm infants had at least three times increased risk (3.4%) when compared to their term counterparts. Large-for-dates (LFDs) and small-for-dates (SFDs) infants had increased risk of manifesting polycythemia which was nearly four times (2.2%) and twenty-five times (13.2%) respectively, as compared to appropriate-for-dates (AFDs) babies (0.5%). About one-third of polycythemic infants had one or more symptoms. The most common symptoms observed was jitteriness (25.9%) followed by respiratory distress (14.8%) and lethargy (11.1%). The mean (+/- SD) hematocrit of symptomatic newborns (76.0 +/- 4.04) was found to be significantly higher (p less than 0.001) as compared to asymptomatic babies (70.84 +/- 2.73). Partial exchange transfusion with plasma was performed in all the symptomatic cases within 8 hours of onset of symptoms. No such intervention was performed in asymptomatic cases. On neurodevelopment follow-up, the development indices (MDI and PDI) of both asymptomatic and symptomatic cases were found to be comparable.

Immune status following measles vaccination in infants and evaluation for the need of revaccination.

In this prospective study, immune status of children vaccinated in infancy was determined at age 12-18 months. In 200 children, preimmunization protective measles hemagglutination (HI) antibody titres (greater than or equal to 1:8) were present in 38.5% of children of 6-8 months, the frequency decreased to 17.6 and 14.3% in age groups 9-11 and 12-18 months, respectively followed by an increasing incidence of 52.5% in those more than 18 months of age. Paired measles HI titre was estimated in 56 children, the post vaccination sample was taken at age 12-18 months, 3-9 months after measles vaccination. Most of the children (98.0%), with no detectable antibody titre, had a protective titre. Again a significant number (p less than 0.001) of children aged 12-18 months had protective HI titres compared to non-vaccinated. These findings suggest that when vaccinated at 9-11 months in our country, there is no need for revaccination later.

Mortality patterns in low birth weight babies in ICDS urban slum area.

There were 920 live-births over the period of one year in urban slums (covering 40 anganwadi centres) of Gorakhpur city. Incidence of low birth weight (LBW) babies weighing 2.5 kg or less and those weighing 2 kg or less were 40.7% (19.8% preterm LBW and 80.2% term LBW) and 24% (25.3% preterm LBW and 74.7% term LBW) respectively. Incidence of preterm babies was 8.5%. Infections and respiratory distress were found to be the major killers of LBW babies. The neonatal mortality rate was observed to be significantly high in LBW and preterm babies. Again, babies weighing 2 kg or less and preterm were at greater risk and should be referred to specialised neonatal centres while those weighing 2.001-2.5 kg could be looked after at home by trained personnel in domiciliary newborn care.