Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study.

OBJECTIVES: Kangaroo Mother Care (KMC), prolonged skin-to-skin care of the low birth weight baby with the mother plus exclusive breastfeeding reduces neonatal mortality. Global KMC coverage is low. This study was conducted to develop and evaluate context-adapted implementation models to achieve improved coverage. DESIGN: This study used mixed-methods applying implementation science to develop an adaptable strategy to improve implementation. Formative research informed the initial model which was refined in three iterative cycles. The models included three components: (1) maximising access to KMC-implementing facilities, (2) ensuring KMC initiation and maintenance in facilities and (3) supporting continuation at home postdischarge. PARTICIPANTS: 3804 infants of birth weight under 2000 g who survived the first 3 days, were available in the study area and whose mother resided in the study area. MAIN OUTCOME MEASURES: The primary outcomes were coverage of KMC during the 24 hours prior to discharge and at 7 days postdischarge. RESULTS: Key barriers and solutions were identified for scaling up KMC. The resulting implementation model achieved high population-based coverage. KMC initiation reached 68%-86% of infants in Ethiopian sites and 87% in Indian sites. At discharge, KMC was provided to 68% of infants in Ethiopia and 55% in India. At 7 days postdischarge, KMC was provided to 53%-65% of infants in all sites, except Oromia (38%) and Karnataka (36%). CONCLUSIONS: This study shows how high coverage of KMC can be achieved using context-adapted models based on implementation science. They were supported by government leadership, health workers' conviction that KMC is the standard of care, women's and families' acceptance of KMC, and changes in infrastructure, policy, skills and practice. TRIAL REGISTRATION NUMBERS: ISRCTN12286667; CTRI/2017/07/008988; NCT03098069; NCT03419416; NCT03506698.

Simulation training to improve aseptic non-touch technique and success during intravenous cannulation-effect on hospital-acquired blood stream infection and knowledge retention after 6 months: The snowball effect theory.

BACKGROUND: Intravenous cannulation is a common procedure and a valuable skill in the neonatal intensive care unit. Standardized procedure and personnel training are needed in the unit to prevent hospital-acquired blood stream infections. Hence, we evaluated the effect of training using a low-fidelity simulation on the improvement of the aseptic non-touch technique during intravenous cannulation and knowledge retention after 6 months. METHODS: The study was conducted in a tertiary care neonatal unit from June 2017 to July 2018. All the staff nurses and junior resident doctors posted in the neonatal intensive care were included in the study. A protocol and checklist score sheet was developed. The score sheet consisted of 23 items with a total score of 46. Participants were expected to obtain a minimum of 80%. A pre-test was conducted initially, followed by a formal training and then a post-test. The NITA newborn venous access mannequin was used to facilitate the training. A re-training for new nurses was conducted after 6 months. Data were analyzed using paired t-test. RESULTS: A total of 29 doctors and nurses were enrolled in the training. The mean pre-test score was 29.93 compared to 42.66 in the post-test scores (mean difference 12.24(95% confidence interval: 9.39-16.05), p < 0.01. The mean scores were higher when the simulation was conducted after 6 months. There was a significant decline in blood stream infection rates from 5.5 to 1.65 per 1000 patient days (p = 0.05). CONCLUSION: Simulation-based training of health care personnel is a good modality to improve aseptic non-touch technique during intravenous cannulation in the neonatal intensive care unit. Simulation-based training also helps in knowledge retention and standardization of training procedures.

Efficacy of modified Tochen's formula for optimum endotracheal tube placement in low birth weight neonates: an RCT.

OBJECTIVE: To assess the efficacy of modified Tochen's formula (birth weight + 5 cm) when compared to Tochen's formula for optimum placement of endotracheal tubes (ET) in low birth weight (LBW) neonates. STUDY DESIGN: In the NICU of a tertiary care hospital, LBW babies requiring intubation were randomized to Tochen's formula or modified Tochen's formula. The incidence of inadequate placement and optimum length of ET insertion were estimated. Analysis was done by the Chi square and 't'-tests. RESULTS: Sixty-seven babies were included: 34 in Tochen's group and 33 in modified Tochen's group. Baseline characteristics were similar. Modified Tochen's formula was significantly (p = 0.006) closer to the optimum position when compared to Tochen's formula. The percentages of optimum and adequate placements of the ET tube was higher in the modified Tochen's group, though not statistically significant. CONCLUSION: Modified Tochen's formula in LBW babies may enable more optimum placement of ETs.

Perfusion Index-Bedside Diagnosis of Hemodynamically Significant Patent Ductus Arteriosus.

BACKGROUND: Patent ductus arteriosus (PDA) is a significant problem in preterm babies <34 weeks old. Echocardiogram (echo) is the gold standard for diagnosing PDA. Perfusion index (PI) using a pulse oximeter could aid in diagnosing a hemodynamically significant PDA (HsPDA). OBJECTIVE: To evaluate the accuracy of delta-PI (ΔPI; pre-ductal - post-ductal PI) in diagnosing HsPDA in preterm babies <34 weeks old. DESIGN: Prospective analytical cross-sectional (observational) study. METHODS: Preterm infants <34 weeks old (n = 27) were enrolled in the study after parental consent. ΔPI was calculated on Days 1 and 3. Babies are categorized into two groups-HsPDA and no HsPDA based on echo on Day 3. RESULTS: The mean gestational ages were 30.4 ± 1.9 (HsPDA) and 31.7 ± 1.6 weeks (no HsPDA), and birth weights were 1.23 ± 0.32 kg and 1.43 ± 0.34 kg, respectively (p > 0.05). Ten infants had HsPDA. The ΔPI values in Groups A and B differed significantly on Days 1 and 3 (Day 1: 1.06 ± 0.3 vs. 0.54 ± 0.2 and Day 3: 1.11 ± 0.15 vs. 0.57 ± 0.3). The area under the receiver operating characteristic curve was significant for ΔPI on Days 1 and 3. The ΔPI > 0.85 on Day 1 and > 0.95 on Day 3 had a sensitivity and specificity of 80% and 94% and 80% and 88.2%, respectively, for diagnosing HsPDA. CONCLUSION: ΔPI is a useful, simple parameter, which could help in the assessment of PDA in preterm babies.

Pegylated interferon alfa-2b plus ribavirin for treatment of chronic hepatitis C.

AIM: To study the safety and efficacy of pegylated interferon alfa-2b, indigenously developed in India, plus ribavirin in treatment of hepatitis C virus (HCV). METHODS: One-hundred HCV patients were enrolled in an open-label, multicenter trial. Patients were treated with pegylated interferon alfa-2b 1.5 µg/kg per week subcutaneously plus oral ribavirin 800 mg/d for patients with genotypes 2 and 3 for 24 wk. The same dose of peginterferon plus weight-based ribavirin (800 mg/d for ≤ 65 kg; 1000 mg/d for > 65-85 kg; 1200 mg/d for > 85-105 kg; 1400 mg/d for > 105 kg body weight) was administered for 48 wk for patients with genotypes 1 and 4. Serological and biochemical responses of patients were assessed. RESULTS: Eighty-two patients (35 in genotypes 1 and 4 and 47 in 2 and 3), completed the study. In genotype 1, 25.9% of patients achieved rapid virologic response (RVR): while the figures were 74.1% for early virologic response (EVR) and 44.4% for sustained virologic response (SVR). For genotypes 2 and 3, all patients bar one belonged to genotype 3, and of those, 71.4%, 87.5%, and 64.3% achieved RVR, EVR, and SVR, respectively. In genotype 4, 58.8%, 88.2%, and 52.9% of patients achieved RVR, EVR, and SVR, respectively. The majority of patients attained normal levels of alanine aminotransferase by 4-12 wk of therapy. Most patients showed a good tolerance for the treatment, although mild-to-moderate adverse events were exhibited; only two patients discontinued the study medication due to serious adverse events (SAEs). Eleven SAEs were observed in nine patients; however, only four SAEs were related to study medication. CONCLUSION: Peginterferon alfa-2b, which was developed in India, in combination with ribavirin, is a safe and effective drug in the treatment of HCV.

PAIN--perception and assessment of painful procedures in the NICU.

This prospective cross-sectional study was undertaken to determine the frequency of procedural pain among 101 neonates in the first 14 days of admission to a neonatal intensive care unit (NICU) in South India and to study the perception of health-care professionals (HCP) about newborn procedural pain. The total number of painful procedures was 8.09 ± 5.53 per baby per day and 68.32 ± 64.78 per baby during hospital stay. The most common procedure was heel prick (30%). The HCP were administered a questionnaire to assess their perception of pain for various procedures. Procedures were perceived as more painful by nurses than by doctors. Chest tube placements and lumbar puncture were considered most painful. This study shows that the neonates in the NICU in developing countries experience many painful procedures. The awareness about this intensity of pain should provide a valuable tool in formulating pain-reduction protocols for management in low resource settings.

Relationship between serum HBsAg level, HBV DNA level, and peripheral immune cells in patients with chronic hepatitis B virus infection.

BACKGROUND: The chronicity of hepatitis B virus (HBV) infection is attributed to inappropriate functioning of cell-mediated immunity. Besides the importance of measuring serum HBV DNA and HBV surface antigen (HBsAg) as markers of viral replication and exposure, respectively, studies regarding their influence on immune cell status in chronic HBV infection are still scarce. Because such studies of chronic HBV patients have not been reported for India, we attempted to evaluate the relationship between serum concentrations of HBsAg, HBV DNA, and percentage of immune cells in peripheral blood of Indian subjects with chronic HBV infection. METHODS: Thirty-one HbsAg-positive subjects were evaluated for serum HBe antigen (HBeAg), anti-HBe, and alanine transferase status by standard enzyme-linked immunosorbent assay (ELISA) and biochemical procedures. Serum HBV DNA level was determined by real-time TaqMan® polymerase chain reaction assay. Serum HBsAg level was measured by a third-generation sandwich ELISA kit. Peripheral immune cell profiling was done by multifluorometric flow cytometry analysis, for which 21 healthy subjects were included as controls. RESULTS: The majority (93.5%) of the study subjects were HBeAg-negative and anti-HBeAg-positive. Mean viral load, HBsAg, and alanine transferase levels were 4.20 ± 1.96 log copies/mL, 5.98 ± 4.62 log IU/mL, and 74.5 ± 110 IU/mL, respectively. In comparison with controls, total T cell and cytotoxic T cell populations were significantly (P < 0.05) reduced in HBV-infected subjects, while the status of B cells, natural killer cells, T helper cells, and ratio of T helper to cytotoxic cells remained unaltered. CONCLUSION: Suppression of the peripheral cytotoxic T cell population in chronic HBeAg-negative chronic HBV infection is influenced by increased viral load. Serum HBsAg concentration appeared independent of serum HBV DNA level and immune cell status. Nonelevation of natural killer cell and T helper cell numbers in subjects harboring lower to moderate HBV loads is further indicative of noninduction of innate as well as a coordinated adaptive immune response favoring chronicity of the disease.