Suman Rao

Monitoring the postnatal growth of preterm infants: A paradigm change

There is no evidence that preterm postnatal growth should mimic that of healthy fetuses. It is seldom achieved and creates extrauterine growth–restricted or overfat infants. There is no consensus regarding how the growth of preterm infants should be monitored or what constitutes their ideal pattern of growth, especially after term-corrected age. The concept that the growth of preterm infants should match that of healthy fetuses is not substantiated by data and, in practice, is seldom attained, particularly for very preterm infants. Hence, by hospital discharge, many preterm infants are classified as postnatal growth–restricted. In a recent systematic review, 61 longitudinal reference charts were identified, most with considerable limitations in the quality of gestational age estimation, anthropometric measures, feeding regimens, and how morbidities were described. We suggest that the correct comparator for assessing the growth of preterm infants, especially those who are moderately or late preterm, is a cohort of preterm newborns (not fetuses or term infants) with an uncomplicated intrauterine life and low neonatal and infant morbidity. Such growth monitoring should be comprehensive, as recommended for term infants, and should include assessments of postnatal length, head circumference, weight/length ratio, and, if possible, fat and fat-free mass. Preterm postnatal growth standards meeting these criteria are now available and may be used to assess preterm infants until 64 weeks’ postmenstrual age (6 months’ corrected age), the time at which they overlap, without the need for any adjustment, with the World Health Organization Child Growth Standards for term newborns. Despite remaining nutritional gaps, 90% of preterm newborns (ie, moderate to late preterm infants) can be monitored by using the International Fetal and Newborn Growth Consortium for the 21st Century Preterm Postnatal Growth Standards from birth until life at home.

Topical Anesthesia or Oral Dextrose for the Relief of Pain in Screening for Retinopathy of Prematurity: a Randomized Controlled Double-blinded Trial

OBJECTIVE Compare efficacy of 0.5% proparacaine eye drops and oral 25% dextrose in reducing pain during screening for retinopathy of prematurity (ROP). PATIENTS AND METHODS Double-blinded randomized controlled trial. Twenty eligible babies were randomized. Group I received 0.5% proparacaine eye drops at first ROP screening, while Group II received 25% dextrose orally. At second examination, babies received no intervention. Pain was assessed using Premature Infant Pain Profile (PIPP) score. RESULTS The mean ( ± SD) PIPP during procedure in Group I were 15.5 ± 2.06 and 14 ± 2.4 at first and second screening (p = 0.259). The mean ( ± SD) PIPP in Group II were 14.2 ± 1. 8 and 14.9 ± 2.5 at the first and second screening (p = 0.428). Differences were not statistically significant. The PIPP scores of Group I and Group II at the first screening were also not significantly different (p = 0.165). CONCLUSION ROP screening causes moderate to severe pain and neither proparacaine nor dextrose is an effective analgesic.

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

Background 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. Methods 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. Results 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

Variability in Survival of Very Low Birth Weight Neonates in Hospitals of India

5.60 overall per delivery. Conclusions 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. Trial Registration ClinicalTrials.gov NCT02004912

Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy — A Multi-centric Study

This prospective cohort study was conducted to evaluate variability in mortality of very low birth weight (VLBW) neonates during their birth hospitalization in different hospitals of India. A liveborn neonate was eligible for inclusion in the study if it was born or admitted in a participating hospital between 1st January and 31st December 2012 and weighed 1500g or less at birth. Neonates were given clinical care as per standard protocols. Standardized neonatal mortality ratio (SNMR) was calculated as the ratio of the observed mortality to the expected mortality. Expected mortality rate for each unit was calculated by adjusting for various prognostic factors at the time of birth or admission in the participating unit. Among 1345 neonates [mean birth weight: 1168 ± 240g, median gestation: 30wk (IQR: 28–32)] enrolled in the study 199 (14.8%) died before hospital discharge. Although variation in inter-hospital SNMR was statistically insignificant (P 0.49), 95% CI of SNMR of most hospitals was broad reaching level of clinical significance on both sides of line of equivalence. This indicates the need to establish an ongoing quality-improvement collaborative network to identify and adopt clinical practices associated with decreased mortality.

Remote biomonitoring of temperatures in mothers and newborns: design, development and testing of a wearable sensor device in a tertiary-care hospital in southern India

ObjectiveTo assess the feasibility and safety of cooling asphyxiated neonates using phase changing material based device across different neonatal intensive care units in India.DesignMulti-centric uncontrolled clinical trial.Setting11 level 3 neonatal units in India from November 2014 to December 2015.Participants103 newborn infants with perinatal asphyxia, satisfying pre-defined criteria for therapeutic hypothermia.InterventionTherapeutic hypothermia was provided using phase changing material based device to a target temperature of 33.5±0.5ºC, with a standard protocol. Core body temperature was monitored continuously using a rectal probe during the cooling and rewarming phase and for 12 hours after the rewarming was complete.Outcome measuresFeasibility measure - Time taken to reach target temperature, fluctuation of the core body temperature during the cooling phase and proportion of temperature recordings outside the target range. Safety measure - adverse events during coolingResultsThe median (IQR) of time taken to reach target temperature was 90 (45, 120) minutes. The mean (SD) deviation of temperature during cooling phase was 33.5 (0.39) ºC. Temperature readings were outside the target range in 10.8% (5.1% of the readings were <33°C and 5.7% were >34°C). Mean (SD) of rate of rewarming was 0.28 (0.13)°C per hour. The common adverse events were shock/hypotension (18%), coagulopathy (21.4%), sepsis/probable sepsis (20.4%) and thrombocytopenia (10.7%). Cooling was discontinued before 72 hours in 18 (17.5%) babies due to reasons such as hemodynamic instability/refractory shock, persistent pulmonary hypertension or bleeding. 7 (6.8%) babies died during hospitalization.ConclusionUsing phase changing material based cooling device and a standard protocol, it was feasible and safe to provide therapeutic hypothermia to asphyxiated neonates across different neonatal units in India. Maintenance of target temperature was comparable to standard servo-controlled equipment.

Design of a Wearable Remote Neonatal Health Monitoring Device

Objective Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India. Methods Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of ‘social innovation’ design. The device underwent multiple iterations in product design and engineering based on user feedback, and then following preclinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care teaching hospital in Bangalore, India. Clinical trial phases I and IIa for evaluation of safety and efficacy were undertaken in the following sequence: 7 healthy adult volunteers; 18 healthy mothers; 3 healthy babies; 10 stable babies in the neonatal care intensive unit and 1 baby with morbidities. Time-stamped skin temperature readings obtained at 5 min intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice. Results Devices were comfortably secured on to adults and neonates, and data were efficiently transmitted via the gateway device for secure storage and retrieval for analysis. The mean skin temperatures in mothers were lower than the axillary temperatures by 2°C; and in newborns, there was a precision of –0.5°C relative to axillary measurements. While occasional minimal adverse events were noted in healthy volunteers, no adverse events were noted in mothers or neonates. Conclusions This proof-of-concept study shows that this device is promising in terms of feasibility, safety and accuracy (with appropriate calibration) with potential for further refinements in device accuracy and pursuit of further phases of clinical research for improved maternal and neonatal health.

Online Neonatal Training and Orientation Programme in India (ONTOP-IN)—The Way Forward for Distance Education in Developing Countries

In this text we present the design of a wearable health monitoring device capable of remotely monitoring health parameters of neonates for the first few weeks after birth. The device is primarily aimed at continuously tracking the skin temperature to indicate the onset of hypothermia in newborns. A medical grade thermistor is responsible for temperature measurement and is directly interfaced to a microcontroller with an integrated bluetooth low energy radio. An inertial sensor is also present in the device to facilitate breathing rate measurement which has been discussed briefly. Sensed data is transferred securely over bluetooth low energy radio to a nearby gateway, which relays the information to a central database for real time monitoring. Low power optimizations at both the circuit and software levels ensure a prolonged battery life. The device is packaged in a baby friendly, water proof housing and is easily sterilizable and reusable.