Childhood Intussusception after Introduction of Indigenous Rotavirus Vaccine: Hospital-Based Surveillance Study from Odisha, India.

OBJECTIVE: To study the epidemiology of intussusception in children < 2 y of age, postintroduction of Rotavac® (an indigenous oral rotavirus vaccine). METHODS: A multicenter hospital-based surveillance was conducted in Odisha from February 2016 to June 2019. The cases were diagnosed according to Brighton level-1 criteria. Data were collected regarding the time of onset, signs and symptoms, radiological diagnosis, management, complications, and outcome (discharged/died). RESULTS: One hundred and twenty children < 2 y of age were enrolled. The median age was 7 mo (M:F ratio = 2:1). The most common clinical feature was abdominal distention and blood in stool. The most common method for treatment was hydrostatic/pneumatic reduction. Median time (days) between symptom onset and admission was 2. Median (IQR) duration (days) of hospitalization was 5. Most common location of intussusceptions was ileo-colic. CONCLUSIONS: Hydrostatic/pneumatic reduction was possible in the majority presenting ≤ 48 h of symptom onset, and those presenting > 48 h mostly required surgical reduction. Intestinal resection was required in some cases presenting on day 5 of symptom onset. Majority of cases were managed by surgical reduction in Government facility.

Rotavirus Gastroenteritis Hospitalizations Among Under-Five Children in Bhubaneswar, Odisha, India.

OBJECTIVE: To report rotavirus-associated AGE (AGE) profile of admitted children among vaccine-introduced areas in Bhubaneswar, Odisha. METHODS: This study was conducted between 2016 and 2019 at the Capital Hospital, Jagannath hospital and Hi-Tech Medical College and Hospital. All AGE patients below five years old, hospitalized in the study facilities were enrolled. A stool sample was collected and transported to the central laboratory (Christian Medical College, Vellore) for rotavirus antigen detection and genotyping. Clinical and demographic information was collected using a predesigned case report format (CRF). RESULTS: Out of the 1213 stool samples, 447 (36.9%) were identified to have rotavirus with 350 (78.3%) of them belonging to 6 mo to 2 y age group. Rotavirus gastroenteritis exhibited a single peak from November to February. A total of 414 (92.6%) of rotavirus gastroenteritis children had severe or very severe dehydration with odds of rotavirus diarrhea leading to severe dehydration being 1.5 (95% CI, 1-2.4) compared to moderate dehydration. The common genotype combination was G3P[8] (46%) followed by G1P[8] (19%), G2P[4] (5%), and G9P[4] (3%). CONCLUSION: Rotavirus gastroenteritis peaked between December to February while the most common genotype combination among the rotavirus GE was G3P[8] and G1P[8]. The present study provides the clinical profile of admitted children in the hospitals with diarrhea and the circulating strains of rotavirus which will help in documenting the epidemiology and the performance of vaccine against the disease in the state.

Immunogenicity and safety of a liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured by Human Biologicals Institute in 6-8 weeks old healthy infants: A phase III, randomized, single blind, non-inferiority study.

BACKGROUND: A liquid Pentavalent (DTwP-Hb-Hib) combination vaccine, developed by Human Biologicals Institute, underwent a Phase III clinical study in India. In this randomized, single blind, non-inferiority study, the immunogenicity and safety of this Investigational vaccine was compared with Pentavac SD® vaccine in 6-8 weeks old healthy infants. METHODS: A total of 405 healthy infants aged 6-8 weeks old were randomized in 2:1 ratio to receive three doses of either the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine at four to six weeks interval. Immunogenicity was compared by estimation of antibody titers before the first dose and 4-6 weeks after the third dose of vaccination. Safety of each vaccine was assessed and compared by collection of data on solicited and unsolicited adverse events throughout the study period. RESULTS: Out of a total of 405 enrolled subjects, 387 subjects completed the study. The seroconversion rates, seroprotection rates and geometric mean titres of the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine group were found to be comparable and non-inferior to the Pentavac SD® vaccine group at 4-6 weeks after the third dose of vaccination. Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups. No vaccine related serious adverse event was reported. In this study, both the Investigational vaccine as well as the Comparator vaccine were found to be immunogenic and well tolerated. CONCLUSION: After assessment of the results of the study it was concluded that the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine developed by Human Biologicals Institute was immunogenic and safe when administered to infants aged 6-8 weeks and was non-inferior in immunogenicity and safety to Pentavac SD® vaccine. Clinical Trial Registry of India Identifier: CTRI/2016/01/006541.

Anterior Superior Iliac Spine to the Tibial Tuberosity Length: An Easier, Accurate, and Faster Method for Predicting Orogastric Tube Length in Neonates-An Observational Study.

Orogastric tube (OGT) procedures are done in 20% of newborn unit cases. This study was contemplated to work out a formula to predict OGT length in terms of femur length in neonates and its agreement to existing standards. In this observational study, OGT length was estimated using NEMU (nose-ear-mid umbilicus) in 53 consecutive newborns. Their anterior superior iliac spine to tibial tuberosity length (AS-TT) was measured and equated using linear regression analysis in Stata. We further verified the accuracy of the new formula and comparison of time taken by both the methods. Strong positive correlation was seen between OGT and AS-TT (r = .88). OGT length was 10.14 + 0.88 AS-TT, which can be used in neonatal intensive care unit newborns with greater accuracy and with lesser time than the classical method. Strong agreement levels were seen. AS-TT closely relates to the femur length and can be chosen as a guide as it is faster when compared to other methods.