Comparison of stool colonization in premature infants by three dose regimes of a probiotic combination: a randomized controlled trial.

OBJECTIVE: To compare stool colonization among premature infants receiving high-dose probiotics versus standard dose. STUDY DESIGN: This blinded, randomized, placebo-controlled trial was conducted in a Level III neonatal unit. Eligibility criteria were gestational age 27-33 weeks, age < 96 hours, tolerating milk ≥ 15 mL/kg/day and availability for follow-up. Gastro-intestinal/life-threatening malformations and necrotizing enterocolitis/sepsis were exclusions. A total of 149 subjects were randomly allocated to groups A through D (received 12-hourly probiotic supplements of 10(10) cells for 21 days, 10(10) cells for 14 days, 10(9) cells for 21 days and placebo, respectively). Key outcome was stool colonization by a probiotic organism at 28 days. RESULTS: Colonization with Lactobacillus and Bifidobacterium was significantly higher in groups A, B, and C versus placebo respectively, but groups A through C did not differ from each other. There were trends toward more colony forming unit (cfu) of Lactobacillus and Bifidobacterium per milliliter of stool in group A versus B and B versus C. Groups A and B and spontaneous preterm labor (SPL) independently predicted high Lactobacillus counts on day 28; groups A, B, and C and SPL predicted high Bifidobacterium counts. CONCLUSION: Proportion of infants colonized with probiotic species was similar with high-dose and standard dose regimes.

Longitudinal growth of very low birth weight neonates during first year of life and risk factors for malnutrition in a developing country.

AIMS: To study growth of very low birth weight neonates (VLBW) during first year and identify risk factors for malnutrition. METHODS: Neonates ≤34 weeks and ≤1500 g enrolled in a human milk fortification trial were prospectively followed till 1 year corrected age (CA). Anthropometry was plotted on WHO charts. Risk factors were compared between well nourished and underweight infants. RESULTS: One hundred and thirty-two, 127, 110, 99 and 101 neonates were followed at CA of 40 weeks, 3, 6, 9 and 12 months. Weight (Mean Z score -2.3 ± 1.2 to -1.7 ± 1.4; p = 0.005) and length (-2.1 ± 1.5 to -1.5 ± 1.3; p = 0.004) improved significantly, from 40 weeks to one year while head circumference declined (-0.92 ± 1.1 to -1.2 ± 1.1; p < 0.001). Incidence of underweight, stunting, microcephaly and wasting changed from 63%, 53%, 13% and 52% neonates at 40 weeks to 41%, 32%, 21% and 27% at one year. Growth between fortified and unfortified or small for gestational age (SGA) and appropriate for gestational age (AGA) groups were similar, while extremely low birth weight (ELBW) neonates showed poorer growth. Z score of weight at 3 months emerged as an independent predictor of malnutrition at one year. CONCLUSION: VLBW neonates, especially the ELBW group remained growth retarded at CA of one year. Z score of weight at 3 months was a significant risk factor for malnutrition at one year.

Postnatal percentile growth charts for Indian appropriate for gestational age (AGA) very low birth weight babies.

AIMS: To develop postnatal percentile growth charts for Indian very low birth weight (VLBW) appropriate for gestational age (AGA) babies till 37 weeks post conceptional age (PCA). METHODS: Prospective, mixed longitudinal study in 105 VLBW AGA (male 73 and female 32) babies weighing <1500 g and <34 weeks gestation born over 1 year. All were weighed daily until discharge and then weekly till 37 weeks of PCA. The percentile weight curves were computed in four categories : ≤28 weeks, 29-30, 31-32 and 33 weeks, and a total of seven percentile distributions (3rd, 10th, 25th, 50th, 75th, 90th& 97th) were generated. Entire data were subjected to Tanner's 1951 method to compute mean and standard deviation for body weight. The arithmetic mean served the 50(th) percentile. RESULTS: All babies at birth were <50th centile as per Lubchenco's intrauterine growth chart. This pattern was more evident in higher gestation (31-32 and 33 weeks) than lower gestation (≤28 and 29-30 weeks). At 37 weeks PCA, all were <10th centile and the lowest was in ≤28 weeks gestation. CONCLUSIONS: Our babies are born smaller, and growth rate is slower than their western counterparts. Babies at lowest gestation had slowest postnatal growth. Hence, we need a separate growth chart for our babies.

Feed intolerance and necrotizing enterocolitis in preterm small-for-gestational age neonates with normal umbilical artery Doppler flow.

This was a prospective observational study conducted in a level III neonatal unit in North India to measure the incidence of feed intolerance and necrotizing enterocolitis (NEC) in preterm small for gestational age (SGA) neonates with normal umbilical artery Doppler flow in comparison with gestation matched appropriate for gestational age (AGA) neonates. Fifty consecutive singleton SGA preterms between 28 and 34 weeks gestation with normal Doppler were enrolled and 50 gestation matched AGA served as controls. There was a trend toward more feed intolerance (22% vs. 12%, p = 0.183), NEC (12% vs. 6%, p = 0.295) and mortality (8% vs. 2%, p = 0.362) in SGA group and these babies also had significantly more hypoglycemia (p = 0.000) and polycythemia (p = 0.032) and longer hospital stay (p = 0.017).

Galactose specific adhesin of enteroaggregative E. coli induces IL-8 secretion via activation of MAPK and STAT-3 in INT-407 cells.

BACKGROUND: Enteroaggregative Escherichia coli (EAEC) is one of the most common bacterial pathogens associated with the etiology of persistent diarrhea. A characteristic feature of EAEC-pathogenesis is the induction of profound inflammatory response in the intestinal epithelium. The present study was designed to investigate the underlying mechanism of inflammatory responses induced by a novel galactose specific adhesin of T7 strain of EAEC (EAEC-T7) in human intestinal epithelial cell line (INT-407). METHODS: INT-407 cells were stimulated with the adhesin in the absence and presence of anti-adhesin (IgG(AD))/d-galactose/H7/staurosporin (inhibitor of PKC)/PD098059 (inhibitor of MEK)/SB203580 (inhibitor of p38-MAPkinase)/AG490 (inhibitor of JAK (-2,-3)/STAT-3 pathway). The expression of activated Raf-1, MEK-1, ERK1/2, JNK, p38-MAPK and STAT-3 was analyzed by Western immunoblot. Release of interleukin-8 (IL-8) was measured by ELISA. RESULTS: The adhesin was found to induce activation of Raf-1, MEK-1, ERK1/2, p38-MAPK and STAT-3, which was reduced in the presence of IgG(AD)/d-galactose. The activation of Raf-1 was found to be attenuated in the presence of H7/staurosporin. The expression of phosphorylated STAT-3 was downregulated in the presence of AG490 and PD098059. Further, the adhesin induced IL-8 secretion was reduced in the presence of the inhibitors of MEK (PD098059), p38-MAPK (SB203580) and JAK (-2,-3)/STAT-3 pathway (AG490). CONCLUSIONS: We propose that STAT-3 activation is quintessential for the galactose specific adhesin induced IL-8 secretion by INT-407 cells and must occur in concert with the activation of ERK1/2. GENERAL SIGNIFICANCE: Our contribution regarding the galactose specific adhesin mediated signaling leads to an improved understanding of the EAEC-pathogenesis and may provide novel therapeutic approaches to combat EAEC infection.

Validation of visual estimation of neonatal jaundice in low-income and middle-income countries: a multicentre observational cohort study.

OBJECTIVE: Determine the sensitivity and specificity of neonatal jaundice visual estimation by primary healthcare workers (PHWs) and physicians as predictors of hyperbilirubinaemia. DESIGN: Multicentre observational cohort study. SETTING: Hospitals in Chandigarh and Delhi, India; Dhaka, Bangladesh; Durban, South Africa; Kumasi, Ghana; La Paz, Bolivia. PARTICIPANTS: Neonates aged 1-20 days (n=2642) who presented to hospitals for evaluation of acute illness. Infants referred for any reason from another health facility or those needing immediate cardiopulmonary resuscitation were excluded. OUTCOME MEASURES: Infants were evaluated for distribution (head, trunk, distal extremities) and degree (mild, moderate, severe) of jaundice by PHWs and physicians. Serum bilirubin level was determined for infants with jaundice, and analyses of sensitivity and specificity of visual estimations of jaundice used bilirubin thresholds of >260 µmol/L (need for phototherapy) and >340 µmol/L (need for emergency intervention in at-risk and preterm babies). RESULTS: 1241 (47.0%) neonates had jaundice. High sensitivity for detecting neonates with serum bilirubin >340 µmol/L was found for 'any jaundice of the distal extremities (palms or soles) OR deep jaundice of the trunk or head' for both PHWs (89%-100%) and physicians (81%-100%) across study sites; specificity was more variable. 'Any jaundice of the distal extremities' identified by PHWs and physicians had sensitivity of 71%-100% and specificity of 55%-95%, excluding La Paz. For the bilirubin threshold >260 µmol/L, 'any jaundice of the distal extremities OR deep jaundice of the trunk or head' had the highest sensitivity across sites (PHWs: 58%-93%, physicians: 55%-98%). CONCLUSIONS: In settings where serum bilirubin cannot be measured, neonates with any jaundice on the distal extremities should be referred to a hospital for evaluation and management, where delays in serum bilirubin measurement and appropriate treatment are anticipated following referral, the higher sensitivity sign, any jaundice on the distal extremities or deep jaundice of the trunk or head, may be preferred.

Natural history and predictive risk factors of prolonged unconjugated jaundice in the newborn.

BACKGROUND: This study aimed to investigate the natural course and risk factors for prolonged unconjugated jaundice (PUJ) in neonates. METHODS: This was a prospective descriptive study conducted in a tertiary care referral hospital of Northern India. The study included neonates who presented with clinical jaundice beyond 14 days of age. A detailed history, clinical examination and investigations were performed in all. All were followed till the normalization of clinical jaundice or up to 8 weeks of age, whichever was earlier. The key outcome measure was time to normalization of PUJ. Predictive risk factors for PUJ were analyzed by comparing with matched controls. Regression analysis was done for independent predictive risk factors of PUJ. RESULTS: A total of 71 infants presented with prolonged jaundice (PJ). Out of these, 66 infants (93%) had PUJ. Glucose-6-phosphate dehydrogenase (G6PD) deficiency was the most commonly identified association of PUJ (24%). The median duration of jaundice in infants with PUJ was 5 weeks (range: 5-8). PJ in siblings (OR 2.9 [1.1-7.6]), oxytocin use during labor (OR 3.4 [1.1-10.4]) and G6PD deficiency (OR 4.0 [1.1-14.1]) were independent predictors of PUJ. CONCLUSIONS: Irrespective of the etiology, by 8 weeks, PUJ disappeared in all infants. G6PD deficiency was the most common association of PUJ. A history of PJ in siblings, use of oxytocin during labor and G6PD deficiency were independent predictors for PUJ.

Baseline illness severity does not alter accuracy of neonatal sepsis screen.

We investigated the relationship between illness severity and accuracy of neonatal sepsis screen. Consecutive neonates with clinically suspected early onset sepsis (EOS) were enrolled and blood culture and sepsis screen [C-reactive protein, absolute neutrophil count, immature to total ratio (ITR) and microerythrocyte sedimentation rate] were performed. Exclusion criteria were prior antibiotic exposure, nonavailable reports, and contaminated cultures. Score for Neonatal Acute Physiology Perinatal Extension (SNAPPE-II) was used to categorize neonates into "mild to moderate" (score 40) illness. Sepsis was defined as positive blood culture, and positive screen as >or=2 parameters positive. Of 125 subjects, 86 had mild to moderate and 39, severe illness. Twenty-eight (22%) subjects had sepsis. Sensitivity, specificity, negative predictive value, positive predictive value, likelihood ratio of positive test, and likelihood ratio of negative test of the sepsis screen and screen parameters were similar between the two groups. The sensitivity of the screen was 37.5% and 25% for mild to moderate illness and severe illness, respectively. Only ITR values correlated with SNAPPE-II scores in patients with "sepsis" (rho 0.4; P = 0.036). The severity of underlying illness does not alter the performance of the sepsis screen in diagnosing culture-positive EOS.

Neurodevelopmental outcome of acute bilirubin encephalopathy.

The aim of the study was to determine the neurodevelopmental outcome of acute bilirubin encephalopathy (ABE) in children who underwent double volume exchange transfusion (DVET). The 25 referred newborns of ≥ 35 weeks gestation with total serum bilirubin >20 mg dl(-1) and signs of ABE were enrolled and followed up at 3, 6, 9 and 12 months. Denver Development Screening Test (DDST), Neurological examination along with MRI at discharge and brain stem evoked response audiometry (BERA) at 3 months were done. Abnormal neurodevelopment was defined as either (i) cerebral palsy or (ii) abnormal DDST or (iii) abnormal BERA. The mean bilirubin at admission was 37 mg dl(-1). MRI and BERA were abnormal in 61% and 76%. At 1 year, DDST and neurological abnormality were seen in 60% and 27% and 80% had combined abnormal neurodevelopment. MRI had no relation (P = 0.183) but abnormal BERA had a significant association (P = 0.004) with abnormal outcome. Intermediate and advanced stages of ABE associated with significant adverse outcome in spite of DVET.

UGT1A1 gene polymorphisms in North Indian neonates presenting with unconjugated hyperbilirubinemia.

Genetic factors are implicated in pathogenesis of neonatal hyperbilirubinemia. In this nested case-control study, we determined 1) frequency of thymine-adenine (TA)n promoter polymorphism and Gly71Arg mutation in uridine diphosphoglucuronate-glucuronosyltransferase 1A1 (UGT1A1) gene in neonates > or =35-wk gestation presenting with bilirubin levels > or =18 mg/dL and controls, 2) interaction among (TA)n promoter polymorphism, glucose-6-phosphate dehydrogenase (G6PD) gene mutations, and peak bilirubin. The number of TA repeats was assessed by PCR-single-strand conformation polymorphism (SSCP) analysis and Gly71Arg mutation by PCR-RFLP. Fifty samples of both mutations were verified with DNA sequencing. One hundred twenty-seven neonates were enrolled (77 hyperbilirubinemics, 50 controls). The incidence of (TA)n polymorphism was higher in babies with hyperbilirubinemia [89.6% vs. 50%, OR 8.63 (95% CI, 3.2-24.1)]. Gly71Arg mutation was not found either in hyperbilirubinemics or controls. A novel polymorphism (Ala72Pro) at codon position 72 of exon 1 was detected in all 50 samples (21 hyperbilirubinemics, 29 controls), which were sequenced. Presence of variant (TA)n promoter (adjusted OR, 10.6; 95% CI, 3.3-34.2), G6PD deficiency (adjusted OR, 20.6; 95% CI, 3.6-117.3), and history of jaundice in sibling requiring phototherapy (adjusted OR, 12.6; 95% CI, 1.1-141.6) were independent risk factors for bilirubin levels > or =18 mg/dL.

A comparative study of sanitary napkins and absorbent nappy pads for urine output measurement in neonates.

AIM: To compare sanitary napkins and absorbent nappy pads (ANP) for urine output (UO) measurement. METHODS: Phase 1: Freshly passed neonatal urine (5, 10 and 15 mL) was poured onto preweighed sanitary napkins or ANP, which were juxtaposed to the genital area of manikins placed in incubators/warmers and weighed at (1/2), 1, 2, 4, 5 and 6 hr. Outcome was percentage weight change from baseline. Phase 2: Five very low birth weight boys in incubators had UO measurement by test tubes. A sanitary napkin or ANP was co-applied with the test tube for 4 h each. Urine collected in the test tube was measured and poured on the device, which was reapplied. Weight and wetness were checked. RESULTS: Phase 1: Mean urine loss was 8.35, 13.8, 20.1, 25.2, 33.1, 38.7 and 42.6% at (1/2), 1, 2, 3, 4, 5 and 6 h, respectively (repeated measures ANOVA [RM-ANOVA], p < 0.001). Loss was higher with ANP than sanitary napkins (32.1% vs. 13.4%, two-way RM-ANOVA, p = 0.001). There was less loss in incubators versus radiant warmers at 6 h (p = 0.09). Phase 2: There was 12.1 and 26% deficit with sanitary napkin and ANP, respectively. Wetness was felt in one and four cases, respectively. CONCLUSION: Urinary losses are less from sanitary napkins than ANPs.

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants.

AIM: This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix()) in an Indian setting. RESULTS: The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups. PATIENTS AND METHODS: Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study. CONCLUSIONS: Two doses of RIX4414 (Rotarix()) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov; NCT00289172; eTrack 103792.

Novel use of somatostatin receptor scintigraphy in localization of focal congenital hyperinsulinism: promising but fallible.

Congenital hyperinsulinism (CHI) is the most common cause of persistent hypoglycemia in infants and children. The pre-operative differentiation of focal from diffuse forms is extremely important from the management point of view. The current methods for pre-operative differentiation are invasive. We report a patient with CHI where somatostatin receptor scintigraphy was used to diagnose CHI but with limited success. A preoperative 68gallium DOTATOC-PET scan was performed which revealed highly localized radiotracer uptake in the body of the pancreas. 80% of the pancreas including the body was resected. The clinical problems did not completely resolve after surgery. Histopathology revealed hyperplastic islet cells at the resected margin and randomly throughout the pancreas. This case highlights the use of 68gallium DOTATOC-PET scan in a patient with severe CHI. The satellite foci that were missed may be either an inherent limitation of 68Ga DOTATOC scan or an underinterpretation due to lack of expertise. This report opens up a new option of using somatostatin analogue scintigraphy for pre-operative localization of hyperplastic islet cells in patients with CHI.

Blood culture confirmed bacterial sepsis in neonates in a North Indian tertiary care center: changes over the last decade.

The spectrum of organisms causing sepsis is different in developing countries. Data on the recent trends of organisms causing sepsis are limited. This study was conducted in a tertiary care neonatal unit in Northern India. All inborn babies with blood-culture-positive sepsis from 1995 to 2006 were divided into two epochs, viz. 1995 to 1998 (epoch I) and 2001 to 2006 (epoch II). Organisms were grouped into early (<72 h) and late onset (> or =72 h) sepsis groups. The overall incidence of sepsis, the incidence of sepsis stratified by weight groups, the organism profile on different days of life, sepsis-related mortality and pathogen-specific case fatality rate were calculated and compared between the two epochs. Out of 34,362 live births during the study period, organisms were isolated in 1,491 neonates. Out of these, 89% had bacterial sepsis. The incidence of neonatal bacterial sepsis increased from epoch I to epoch II (35.8/1,000 versus 40.1/1,000 live births, P<0.05). The incidence of early onset sepsis (EOS) did not change between the epochs, but the incidence of late onset sepsis (LOS) increased from 12 to 16.5 per 1,000 live births (P<0.001). The incidence of bacterial sepsis decreased significantly in the 1,000- to 1,999-g birth weight groups. Klebsiella pneumoniae and Enterobacter aerogenes decreased, whereas Staphylococcus aureus increased in incidence during epoch II. Non-fermenting Gram-negative bacilli emerged as a newly identified pathogen during epoch II. Sepsis-associated mortality decreased from 42 to 20%. The incidence of bacterial sepsis has decreased significantly in 1,000- to 1,999-g infants, with a significant reduction in sepsis-related mortality. New organisms have emerged in recent years. The organism profile in recent years has changed, with a significant overlap of organisms causing EOS and LOS.

Hydration status of exclusively and partially breastfed near-term newborns in the first week of life.

An in-hospital prospective, observational cohort study was conducted to assess the effects of type of feeding (exclusively breastfed [EBF] vs partially breastfed [PBF]) on the hydration status of near-term newborns in the first week of life. A total of 205 babies of 35 to 37 weeks of completed gestation were enrolled (82 in the EBF group and 123 in the PBF group). The overall incidence of significant weight loss (>or=10%) was 18% with no significant difference between EBF and PBF groups (18.3% vs 17.9%, P=.94). The incidence of hypernatremia (serum NA>or=150 meq/L) was 2.4% in the EBF group and 5.7% in the PBF group (P=.32). The factors associated with significant weight loss in the total cohort were having a mother with previous negative breastfeeding experience (adjusted odds ratio [OR]=16.5, 95% confidence interval [CI]=2.1-115.7), exposure to phototherapy (adjusted OR=9.0, 95% CI=2.5-31.8), and cesarean delivery (adjusted OR=6.7, 95% CI=2.3-19.7).

Evaluation of lactate dehydrogenase, creatine kinase and hepatic enzymes for the retrospective diagnosis of perinatal asphyxia among sick neonates.

It is difficult to make a retrospective diagnosis of perinatal asphyxia in symptomatic neonates delivered non-institutionally. We studied serum creatine kinase muscle-brain fraction (CK-MB), lactate dehydrogenase (LDH), glutamic oxaloacetic transaminase (SGOT) and glutamic pyruvate transaminase (SGPT) for differentiating asphyxiated (n=25) from non-asphyxiated (n=20) neonates who present with non-specific signs of sickness. CK-MB was assayed at 8 and 24 h; and LDH, SGOT and SGPT at 72 h of life. On comparing cases and controls, median 8-hr CK-MB [80 U/L vs. 26 U/L respectively, P< 0.001], median 24-hr CK-MB [33.5 U/L vs. 21.5 U/L respectively, P=0.009] and median LDH [965 U/L vs. 168 U/L respectively, P< 0.001] were higher in asphyxiated neonates. Raised LDH had 100% sensitivity, while CK-MB had 100% specificity for asphyxia. LDH had the highest area under ROC curve (0.998). We conclude that LDH at 72 hr of life is most accurate at differentiating asphyxiated from non-asphyxiated symptomatic neonates.

Single versus multiple courses of antenatal betamethasone and neonatal outcome: a randomized controlled trial.

OBJECTIVES: This study compared the beneficial and adverse neonatal effects of a single versus repeated courses of antenatal betamethasone. SETTING: Tertiary care hospital DESIGN: Open labeled, randomized controlled trial. PARTICIPANTS: Pregnant women (26-33 weeks) at risk of preterm delivery, who received one course of antenatal betamethasone and remained undelivered for 7 days. Those with uncertain gestation, major malformations and frank chorioamnionitis were excluded. INTERVENTIONS: Subjects were randomized to receive weekly antenatal betamethasone until 34 weeks or no further betamethasone. OUTCOME MEASURES: Primary: incidence of severe respiratory distress syndrome (RDS). Secondary: incidence of non-severe RDS and other neonatal morbidity; birth weight, length and occipito-frontal circumference (OFC); and, development and growth at 6 mo corrected age. RESULTS: 38 subjects were allocated to each group. Severe RDS was similar in multiple and single course groups (7% vs. 3% respectively, P=0.34), as was incidence of other morbidity. Composite outcome of RDS and or death within 28 days tended to be less in multiple course group (P=0.07). Birth anthropometry was similar in the 2 groups. At 6 mo corrected age (n=44), weight and length were significantly lower in multiple course group (p=0.003 and P=0.007, respectively), whereas OFC was not different (P=0.1). There were no differences vis a vis neurodevelopmental outcomes. CONCLUSIONS: A single course of antenatal betamethasone was as efficacious as multiple courses, with respect to prevention of neonatal morbidity. Multiple antenatal betamethasone courses have long-term adverse effects on infant weight and length growth, but not on OFC and neurodevelopment.

WINROP algorithm for prediction of sight threatening retinopathy of prematurity: Initial experience in Indian preterm infants.

PURPOSE: To determine the efficacy of the online monitoring tool, WINROP (https://winrop.com/) in detecting sight-threatening type 1 retinopathy of prematurity (ROP) in Indian preterm infants. METHODS: Birth weight, gestational age, and weekly weight measurements of seventy preterm infants (<32 weeks gestation) born between June 2014 and August 2016 were entered into WINROP algorithm. Based on weekly weight gain, WINROP algorithm signaled an alarm to indicate that the infant is at risk for sight-threatening Type 1 ROP. ROP screening was done according to standard guidelines. The negative and positive predictive values were calculated using the sensitivity, specificity, and prevalence of ROP type 1 for the study group. 95% confidence interval (CI) was calculated. RESULTS: Of the seventy infants enrolled in the study, 31 (44.28%) developed Type 1 ROP. WINROP alarm was signaled in 74.28% (52/70) of all infants and 90.32% (28/31) of infants treated for Type 1 ROP. The specificity was 38.46% (15/39). The positive predictive value was 53.84% (95% CI: 39.59-67.53) and negative predictive value was 83.3% (95% CI: 57.73-95.59). CONCLUSION: This is the first study from India using a weight gain-based algorithm for prediction of ROP. Overall sensitivity of WINROP algorithm in detecting Type 1 ROP was 90.32%. The overall specificity was 38.46%. Population-specific tweaking of algorithm may improve the result and practical utility for ophthalmologists and neonatologists.

Low plasma protein C values predict mortality in low birth weight neonates with septicemia.

BACKGROUND: Septicemia activates coagulation and decreases activated protein C (APC). Low APC in adults is associated with multiorgan dysfunction and mortality, but such data in neonates are lacking. Being deficient in APC, neonates may be especially vulnerable to the effects of low APC. METHODS: This cohort study was conducted on 40 neonates with severe bacterial septicemia to determine the relationship between plasma APC values and mortality, time to mortality, and hazard of dying. Low birth weight neonates with sepsis, organ dysfunction, and systemic inflammatory response syndrome were enrolled after parental consent. Plasma APC was assayed at enrollment and subjects were followed for 14 days from enrollment. Low birth weight neonates, who had major malformations, severe birth asphyxia, or received blood products before APC assay, were excluded. PRIMARY OUTCOME: comparison of APC level between survivors and nonsurvivors. SECONDARY OUTCOMES: survival with low versus normal APC; and hazard ratio of APC, adjusted for birth weight, Score for Neonatal Acute Physiology and number of affected organs. RESULTS: Forty of 74 eligible neonates were included. Twenty-five of the enrolled neonates died within 14 days. APC levels in nonsurvivors were lower than in survivors [median (interquartile range) %, 15 (4.5-21) versus 33 (18-55); P < 0.001]. Ten nonsurvivors versus 1 survivor had low APC (P = 0.03). Positive predictive value (PPV) of low APC values for mortality was 90.9%. Survival in the low APC group (n = 11) was shorter than in normal APC group [median (95% confidence interval) days, 3 (2.3-3.7) versus 10, P value <0.001]. APC value was independently associated with hazard of dying [adjusted risk 0.95 (95% confidence interval 0.92-0.99), P = 0.02]. Each 1% rise in APC decreased the hazard of dying by 5%. CONCLUSIONS: Mortality was higher and duration of survival shorter in septic neonates with lower plasma ACP. The latter was an independent predictor of the hazard of dying.

Retinopathy of prematurity in Asian Indian babies weighing greater than 1250 grams at birth: ten year data from a tertiary care center in a developing country.

BACKGROUND: Retinopathy of prematurity (ROP) is an important cause of childhood blindness in developing countries. AIM: To report the spectrum of ROP and associated risk factors in babies weighing > 1250 g at birth in a developing country. SETTING AND DESIGN: Institutional, retrospective, non-randomized, observational clinical case series. MATERIALS AND METHODS: Retrospective analysis (10 years) of 275 eyes (138 babies) with ROP. STATISTICAL ANALYSIS: Qualitative data with the Chi-square test. Quantitative data using the unpaired t test or the ANOVA and further tested using multivariate logistic regression. RESULTS: The mean birth weight was 1533.9 g (range 1251 to 2750 g) and the mean period of gestation was 30.9 weeks (range 26 to 35). One hundred and twenty-four of 275 eyes (45.1%) had threshold or worse ROP. Risk factors for threshold or worse disease were, 'outborn babies' ( P P = 0.007) and exchange transfusion ( P = 0.003). The sensitivity of the American and British screening guidelines to pick up threshold or worse ROP in our study group was 82.4% and 77.4% respectively. CONCLUSIONS: Severe ROP is often encountered in babies weighing greater than 1250 g at birth in developing countries. Western screening guidelines may require modifications before application in developing countries.