Role of oral erythromycin for feed intolerance in neonates - A randomized controlled trial

Objective: The objective of this study was to compare the effect of high and low dose of erythromycin with placebo and to determine the efficacy and safety of oral erythromycin for feed intolerance in neonates admitted to the neonatal intensive care unit. Methodology: The study was a double-blind, randomized, and placebo-controlled trial. Term and preterm babies having feed intolerance were included in the study, and babies with congenital malformations, necrotizing enterocolitis, and sepsis were excluded from the study. After parental consent, the subjects were randomized into Groups 1, 2, or 3 to receive low-dose (3 mg/kg/dose) or high-dose (10 mg/kg/dose) oral erythromycin estolate or the placebo (equal volume of 5% dextrose). Feeding of all the study neonates was managed as per the unit protocol and babies were monitored for the complications. The primary outcome was the time to reach full feeds of 150 ml/kg/day, without significant gastric residuals. Results: Of 58 eligible babies, 84.5% were preterm babies. The median time for reaching full feeds with placebo was 6 days with interquartile range

Glucose levels in first 3 days and neurodevelopmental outcome at 1 year in low birth weight infants: A cohort study

Background: Definition of neonatal hypoglycemia is still controversial. Objective: To find the effect of blood glucose (BG) levelsin the first 3 days of life, on developmental outcome at 1 year in low birth weight neonates <2000 g. Methods: A prospective cohortstudy was conducted in tertiary level neonatal intensive care unit and follow-up clinic in south India. Intramural neonates admittedfrom September 2009 to August 2010 were enrolled. Perinatal and neonatal variables were recorded. Respiratory support, fluids,and feeding management were based on the standard protocols. BG was measured within 2 h, then 6 hourly for 72 h by glucometerand BG <50 mg% was analyzed by hexokinase method. Infants were followed until 1 year corrected age and development age(DA) assessed by Developmental Assessment Scales for Indian Infants (DASII). Motor and mental DA at various BG levelswere compared. Composite outcome of motor or mental developmental delay; or cerebral palsy or hearing impairment or visualimpairment was analyzed, and logistic regression analysis was performed. Results: The mean birth weight and gestation of the studygroup (n=129) was 1493 g and 32.5 weeks. The 10th centile of BG in the first 72 h was 51 mg%. BG below 10th centile was seen in60 infants. The mean motor and mental DA of the infants by DASII assessment at 1 year was 11.3 and 11.5 months, respectively.The motor DA and mental DA were significantly higher until 50 mg% lowest BG level, and positive correlation was seen (r=0.26motor, 0.2 mental DA). Mean BG level, the presence of symptoms; number of episodes or small for gestation did not influence theDA. The adjusted odds for poor composite outcome when BG was below 51 mg% is 2.83 (0.65-12.3). Conclusion: Even thoughhigh-risk neonates with BG <51 mg% have a lower motor DA and mental DA at 1 year, than neonates with BG >50 mg%; othermorbidities do determine their composite outcome

Television viewing and sleep are associated with overweight among urban and semi-urban South Indian children

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Evaluation of the immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Shan 4) with Easyfour™ in Indian infants administered per EPI schedule: A phase III trial

The study was planned to assess and compare immunogenicity and safety of an indigenous DTPw-Hib combination vaccine (Shan 4) with EasyFour, the available DTwP-Hib vaccine in India. Overall 210 healthy infants, six to eight weeks of age, were randomized to receive three doses of either Shan 4 or EasyFour at 6, 10 and 14 weeks of age. Antibodies were analyzed prior to and four to six weeks post third vaccine dose. Solicited and unsolicited local and systemic events in the follow up period after each dose were recorded. Post vaccination 100% of the infants in Shan 4 and EasyFour groups had seroprotective concentrations of Anti PRP-T IgG antibodies, IgG anti-diphtheria toxoid antibodies and IgG anti-tetanus toxoid antibodies. Following third dose of vaccination 86.99% subjects in the Shan 4 group and 73.85% subjects in the EasyFour group seroconverted for anti-pertussis antibody titres. Two Serious Adverse Events (SAEs) were reported during the course of the study, all unrelated to the respective vaccine administered. Most commonly reported adverse events in both the groups were pain at injection site, mild fever (<103°F) and minor swelling at injection site. The study proved that Shan 4 was safe and immunogenic compared to the available licensed vaccine

Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial

<div><p>Background</p><p>In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth.</p><p>Methods</p><p>All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken.</p><p>Results</p><p>Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better knowledge of active management of the third stage of labour (82.4% vs.35.8%, AOR (adjusted odds ratio) 10, 95% C.I 5.5 to 18.2); management of maternal sepsis (73.5% vs. 10.9%, AOR 36.1, 95% C.I 13.6 to 95.9); neonatal resuscitation (48.5% vs.11.7%, AOR 10.7, 95% C.I 4.6 to 25.0) and low birth weight newborn care (58.1% vs. 40.9%, AOR 2.4, 95% C.I 1.2 to 4.7). The case sheet audits revealed that providers in the intervention arm showed greater compliance with the protocols during labour monitoring (77.3% vs. 32.1%, AOR 25.8, 95% C.I 9.6 to 69.4); delivery and immediate post-partum care for mothers (78.6% vs. 31.8%, AOR 22.1, 95% C.I 8.0 to 61.4) and for newborns (73.9% vs. 32.8%, AOR 24.1, 95% C.I 8.1 to 72.0). The cost analysis showed that the intervention cost an additional $5.60 overall per delivery.</p><p>Conclusions</p><p>The mentoring program successfully improved provider preparedness and facility readiness to deal with institutional births and associated complications. It is feasible to improve the quality of institutional births at a large operational scale, without substantial incremental costs.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT02004912" target="_blank">NCT02004912</a></p></div

Facility readiness to deal with maternal and newborn complications in the intervention and control facilities.

<p>Facility readiness to deal with maternal and newborn complications in the intervention and control facilities.</p

Staff nurses’ knowledge about diagnosis and management of complications in the intervention and control facilities.

<p>Staff nurses’ knowledge about diagnosis and management of complications in the intervention and control facilities.</p

Study coverage and respondent characteristics.

<p>Study coverage and respondent characteristics.</p