Safety and effectiveness of BCG vaccination in preterm babies

Aim: To assess the cell mediated immune response to BCG vaccine in preterm babies. Methods:Sixty two consecutive preterm babies born at < 35 weeks of gestation were randomly allocated into two groups. Babies in group A were vaccinated early at 34-35 weeks and group B were vaccinated late at 38-40 weeks of postconceptional age. The two groups were similar in terms of: gestational age (mean (SD) 33.1 (1. 1) and 33 (1.2) weeks, respectively); birthweight 1583 (204) and 1546 (218) g; neonatal problems; socioeconomic status; and postnatal weight gain. The cell mediated immune response to BCG was assessed using the Mantoux test and the lymphocyte migration inhibition test (LMIT) 6-8 weeks after BCG vaccination. Induration of >5 mm after the Mantoux test was taken as a positive response. Results: There was no significant difference in the tuberculin conversion rates (80% and 80.7%, respectively), positive LMIT (86.6% and 90.3%, respectively), or BCG scar (90.0% and 87.1%, respectively) among the two groups. Conclusions: Prematurity seems to be an unlikely cause for poor vaccine uptake. Preterm babies can be effectively vaccinated with BCG at 34-35 weeks of postconceptional age, the normal time of discharge in a developing country

Improving Communication Between Health Care Professionals and Parents: A Quality Improvement Initiative

This quality improvement initiative was undertaken in a tertiary care neonatal intensive care unit (NICU) to improve communication between the HCP and parents related to the sick neonates admitted in NICU as measured by increase in parental satisfaction score from base line (34.5%) to 80% in 3 months time. A team was formulated to evaluate the reasons for low parental satisfaction resulting from communication between HCP and the parents of sick neonates and to further plan strategies for improving the same. Multiple PDSA cycles were implemented. The results of the all PDSA cycles were discussed amongst team members. Satisfaction of parents related to communication with HCP increased to more than 80% in 3 months time followed by increase up to 90% in sustenance phase. Multiple simple feasible interventions led to improvement in communication between the HCP and parents as evident by increase in satisfaction score (40.8 ± 4.3 vs. 40.8 ± 4.3 vs. 91.3 ± 4.8, p < 0.001). There was significant improvement in the satisfaction scores of the mothers on communication related to sick neonate in NICU at the end of intervention phase as well as in the sustenance phase. Multiple simple doable and feasible interventions had led to the improvement in communication between the HCP and parents hence improving the satisfaction of parents related to their communication with HCP

Limb splinting for intravenous cannulae in neonates: A randomised controlled trial

Objective: To evaluate the efficacy of peripheral intravenous (IV) cannula site joint immobilisation by splint application on functional duration of peripheral IV cannula in neonates. Design: Randomised controlled trial. Setting: Neonatal intensive care unit of a tertiary care hospital. Participants: Neonates requiring continuous IV infusion for an expected duration of more than or equal to 72 hours. Intervention: Eligible cannulations were randomised to either “splint” or “no-splint” group. In the splint group, a cardboard splint was used to immobilise the joint at peripheral IV cannula site. No attempt was made to immobilise the limb in the no-splint group. Outcome measure: Functional duration of a peripheral IV cannula measured as interval from time of insertion to the development of predefined sign of removal (extravasation, blockage, inflammation). Results: A total of 69 peripheral IV cannulations in 54 neonates were randomised to either the splint (n = 33) or no-splint group (n = 36). Both groups were comparable in birth weight, gestation, site of cannulation and nature of fluids administered. Mean functional duration of cannula was lesser in the splint group compared to the no-splint group (h; 23.5 (SD15.9) vs 26.9 (SD15.5), mean difference: −3.3 h, 95% CI −11.02 to 4.3 h) although the difference was not statistically significant (p = 0.38). Extravasation at cannula site was found be the commonest indication for cannula removal in both the groups (84% vs 76.5%). Conclusion: Joint immobilisation with splint at cannula site did not improve the functional duration of peripheral IV cannula

Inpatient care of small and sick newborns: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth is the leading cause of child death worldwide. Small and sick newborns require timely, high-quality inpatient care to survive. This includes provision of warmth, feeding support, safe oxygen therapy and effective phototherapy with prevention and treatment of infections. Inpatient care for newborns requires dedicated ward space, staffed by health workers with specialist training and skills. Many of the estimated 2.8 million newborns that die every year do not have access to such specialised care. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks" (or factors that hinder the scale up) of maternal-newborn intervention packages. For this paper, we used quantitative and qualitative methods to analyse the bottleneck data, and combined these with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for inpatient care of small and sick newborns. RESULTS: Inpatient care of small and sick newborns is an intervention package highlighted by all country workshop participants as having critical health system challenges. Health system building blocks with the highest graded (significant or major) bottlenecks were health workforce (10 out of 12 countries) and health financing (10 out of 12 countries), followed by community ownership and partnership (9 out of 12 countries). Priority actions based on solution themes for these bottlenecks are discussed. CONCLUSIONS: Whilst major bottlenecks to the scale-up of quality inpatient newborn care are present, effective solutions exist. For all countries included, there is a critical need for a neonatal nursing cadre. Small and sick newborns require increased, sustained funding with specific insurance schemes to cover inpatient care and avoid catastrophic out-of-pocket payments. Core competencies, by level of care, should be defined for monitoring of newborn inpatient care, as with emergency obstetric care. Rather than fatalism that small and sick newborns will die, community interventions need to create demand for accessible, high-quality, family-centred inpatient care, including kangaroo mother care, so that every newborn can survive and thrive

Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial

Background Evidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation. Methods In this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1) at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group), or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group), using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31–33 weeks). Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ12) based on WHO Multicentre Growth Reference Study growth standards. Analyses were by intention to treat. The trial is registered with Clinical Trials Registry of India, number CTRI/2012/11/003149. Findings Between March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up) and eight infants in the 6 month group (two deaths, six lost to follow-up) were excluded from analysis of primary outcome. There was no difference in WAZ12 between two groups: –1·6 (SD 1·2) in the 4 month group versus –1·6 (SD 1·3) in the 6 month group (mean difference 0·005, 95% CI –0·24 to 0·25; p=0·965). There were more hospital admissions in the 4 month group compared with the 6 month group: 2·5 episodes per 100 infant-months in the 4 month group versus 1·4 episodes per 100 infant-months in the 6 month group (incidence rate ratio 1·8, 95% CI 1·0–3·1, p=0·03). 34 (18%) of 188 infants in the 4 month group required hospital admission, compared with 18 (9%) of 192 infants in the 6 month group. Interpretation Although there was no evidence of effect for the primary endpoint of WAZ12, the higher rate of hospital admission in the 4 month group suggests a recommendation to initiate complementary feeding at 6 months over 4 months of corrected age in infants less than 34 weeks of gestation

Developing Standard Treatment Workflows—way to universal healthcare in India

Primary healthcare caters to nearly 70% of the population in India and provides treatment for approximately 80–90% of common conditions. To achieve universal health coverage (UHC), the Indian healthcare system is gearing up by initiating several schemes such as National Health Protection Scheme, Ayushman Bharat, Nutrition Supplementation Schemes, and Inderdhanush Schemes. The healthcare delivery system is facing challenges such as irrational use of medicines, over- and under-diagnosis, high out-of-pocket expenditure, lack of targeted attention to preventive and promotive health services, and poor referral mechanisms. Healthcare providers are unable to keep pace with the volume of growing new scientific evidence and rising healthcare costs as the literature is not published at the same pace. In addition, there is a lack of common standard treatment guidelines, workflows, and reference manuals from the Government of India. Indian Council of Medical Research in collaboration with the National Health Authority, Govt. of India, and the WHO India country office has developed Standard Treatment Workflows (STWs) with the objective to be utilized at various levels of healthcare starting from primary to tertiary level care. A systematic approach was adopted to formulate the STWs. An advisory committee was constituted for planning and oversight of the process. Specialty experts' group for each specialty comprised of clinicians working at government and private medical colleges and hospitals. The expert groups prioritized the topics through extensive literature searches and meeting with different stakeholders. Then, the contents of each STW were finalized in the form of single-pager infographics. These STWs were further reviewed by an editorial committee before publication. Presently, 125 STWs pertaining to 23 specialties have been developed. It needs to be ensured that STWs are implemented effectively at all levels and ensure quality healthcare at an affordable cost as part of UHC

Transcutaneous bilirubin levels in healthy term and late preterm Indian neonates

Objective: To provide normative data for transcutaneous bilirubin (TcB) measurements in healthy term and late-preterm Indian neonates during first 72 h of age using a multiwavelength reflectance transcutaneous bilimeter. Methods: TcB measurements were performed in healthy neonates (gestation 35 wk), in a well-baby ward, using a multiwavelength transcutaneous bilimeter (BiliCheck®, SpectRx Inc, Norcross, GA). Age-specific percentiles values for each 6-h epoch starting at 0 h of age were calculated and an age-specific TcB nomogram was developed using different percentile values. Diagnostic ability of each percentile curve for prediction of hyperbilirubinemia, defined as requirement of phototherapy, was calculated. Results: We performed 925 TcB measurements on 625 healthy newborn infants (gestation: 35 to 41 wk; age: 0 to 72 h; mean birth weight: 2808±437 g). TcB increased in a linear manner with maximum rate of rise observed during first 24 h of age (50th percentile: 0.22 mg/dL/h). 50th percentile curve of age-specific TcB nomogram had high negative predictive value (99.8%) and acceptable positive predictive value (16.4%) for prediction of hyperbilirubinemia. Conclusion: We provided age-specific nomogram of TcB for first 72 h of age in healthy term and late-preterm Indian neonates. Percentile curves and rate of rise in TcB may help in identification of neonates at low-risk of development of hyperbilirubinemia facilitating their safer discharge from the hospital. Diagnostic utility of this nomogram for predicting hyperbilirubinemia needs to be tested in a separate validation cohort

Development of a quality improvement package for reducing sight-threatening retinopathy of prematurity.

Purpose: With improving survival of preterm neonates, retinopathy of prematurity (ROP) is emerging as a major cause of childhood blindness. Incidence of sight-threatening ROP can be reduced by improving the quality of care provided to preterm neonates. Methods: This before-and-after study was designed to develop a need-based intervention package to improve knowledge, skills, and practices of those providing care for preterm neonates, and to evaluate the effectiveness of this package when combined with point-of-care quality improvement (POCQI) in improving survival of preterm neonates without sight-threatening ROP. The study had a formative component to assess baseline knowledge, skills, practices and attitudes, and to assess the needs of the healthcare staff to improve the care of preterm neonates. It was conducted in four special care neonatal units (SCNU) in the state of Madhya Pradesh in India. Results: A theory of change was developed to guide the development of study tools including needs assessment and educational package development. The educational package thus developed has been tested at the study sites in combination with POCQI projects driven by local teams of healthcare providers. The effectiveness of the interventions has been evaluated by collection of individual-level data on neonates admitted at the study sites. Conclusion: A multidimensional educational package integrated with system changes in the form of quality improvement (QI) endeavours driven by local context and needs were developed and evaluated in the project

Does measuring the changes in TcB value offer better prediction of Hyperbilirubinemia in healthy neonates?

Objective: We evaluated the diagnostic value of changes in transcutaneous bilirubin (TcB) levels for prediction of subsequent hyperbilirubinemia in healthy term and late-preterm neonates. Methods: Neonates at 35 weeks of gestation were enrolled in a prospective study. Two TcB determinations were performed for all enrolled neonates (N = 358). The first assessment (TcB(1)) was performed at 24 +/- 6 hours of age, followed by a second (TcB(2)) >or=12 hours later. Changes in TcB levels were calculated. TcB values were plotted on an hour-specific serum bilirubin nomogram, and risk zones were recorded. Of the 358 neonates enrolled, 325 neonates (91%) were monitored for hyperbilirubinemia until 5 days of age. Results: The mean ages of TcB(1) and TcB(2) estimations were 23 +/- 4 hours and 42 +/- 4 hours, respectively. A total of 14.9% of neonates (48 of 325 neonates) developed hyperbilirubinemia by 5 days of age. The sensitivity, specificity, and positive and negative likelihood ratios for prediction of subsequent hyperbilirubinemia for TcB(1) (zone >2, >75th percentile) were 80.4%, 58.0%, 1.9, and 0.34; those for TcB(2) (zone >2, >75th percentile) were 82.6%, 79.0%, 4.0, and 0.22; and those for the change in TcB levels (>0.18 mg/dL per hour, >75th percentile) were 82.5%, 82.9%, 4.8, and 0.21, respectively. Gestational age, TcB risk zone, and change in TcB levels were found to be independent predictors of subsequent hyperbilirubinemia. Conclusions: Single TcB measurements at 30 to 48 hours predict hyperbilirubinemia with a reasonably high degree of accuracy. Changes in TcB levels do not offer any added clinical benefit

Is zero dose oral polio vaccine effective in preterm babies?

A randomized controlled trial was done to compare seroconversion following a single dose of trivalent oral polio vaccine (TOPV) in preterm babies, vaccinated at two different post-conception ages, with that of term newborns. Sixty-two consecutive preterm babies ≤ 35 weeks were randomly allocated to two groups. Group A was vaccinated ‘early’ at 34–35 weeks and group B ‘late’ at 38–40 weeks post conception. The two groups were comparable in birthweight [mean (SD) 1594 g (118) and 1599 g (126), respectively] and gestational age [mean (SD) 33.2 (1.2) and 33 (1.3) weeks, respectively]. A control group of 36 term babies (group C) were vaccinated in the 1st week of life. Polio virus antibodies were measured immediately before and 6–8 weeks after vaccination. Group A had seroconversion rates of 54.2, 12.5 and 12.5% against polio virus types 1, 2 and 3, respectively, group B had rates of 60.0, 8.0 and 16.0%, and group C rates of 53.6, 10.7 and 14.3%. Differences in the seroconversion rates in the three groups were not statistically significant. The conversion rates against types 2 and 3 are much lower than in previous studies. We conclude that preterm babies vaccinated at 34–35 weeks post conception show seroconversion rates similar to those in term newborns