Simulation Based vs Conventional Training for Initial Steps in Delivery Room Care of Preterm Neonates: An Open Label Randomized Trial

Objective: To assess whether simulation based education (SBE) improves the practices and knowledge of junior residents for stabilization of a preterm neonate in delivery room as compared to conventional education (CE). Methods: This trial randomized 24 pediatric residents to either SBE (n=12) or CE (n=12) groups. One-time SBE was imparted to the SBE group. Both the groups had similar facilitator participant ratio and equally timed sessions. The individual skills scores and performance by preterm stabilization performance evaluation (PSPE) score in real time were recorded using a validated tool within 8 weeks of the training. Knowledge gain was evaluated using pre and post-test scores. Results: The mean (SD) skill and PSPE scores were comparable between the two groups (skill score 51.1 (8.1), 46.5 (7.8), respectively mean difference 4.6; 95% CI -2.1 to 11.3; PSPE-score 80.2 (14.2) vs. 82.9 (10.3); mean difference -2.68; 95% CI -8.35 to 13.71). The mean (SD) knowledge gain was similar in the groups [4.4 (1.9), 5.3 (4.1); mean difference 0.91; 95% CI, -1.81 to 3.64. Conclusion: In junior residents, a one-time SBE session, when compared to conventional task training, did not lead to improvement in the performance of the initial steps of neonatal resuscitation.

Secular Trends in Birthweights in Two Epochs Over 40 Years in a Tertiary Care Center

Objective: To compare the average birthweights and the weight centiles of the ‘new’ growth charts with the ‘old’ (1974) charts developed in the same unit four decades ago. Methods: Birthweight and gestation data of the eligible 12,355 singleton neonates born between 2009 and 2016 at a level-3 neonatal unit at a public sector hospital were used to develop the new growth chart. We then compared the prevalence of small for gestational age (SGA) and large for gestational age (LGA) classified by the new charts and the old charts, the incidence of short-term adverse outcomes among them, and the diagnostic performance of both the charts to identify the adverse outcomes in a separate validation cohort. Results: The mean birthweights of boys and girls across all gestations were higher by 150-200 g and 100-150 g, respectively, in the new chart. The prevalence of SGA doubled (9.8% vs 4.7%), but LGA decreased by one-third (17.5% vs 25.9%) with the new chart. However, the proportion of SGA and LGA having one or more short-term adverse outcomes, and the diagnostic performance of both the charts to identify neonates with shortterm adverse outcomes, were comparable. Conclusion: There was an upward shift in the birthweights by about 150 g across all gestations in the new chart compared to the old chart developed 40 years ago. The findings imply the need to consider using updated growth charts to ensure accurate classification of size at birth of neonates.

Predictors of Mortality among Neonates with Congenital Diaphragmatic Hernia: Experience from an Inborn Unselected Cohort in India

Objective: To evaluate the clinical profile and predictors of mortality in neonates withcongenital diaphragmatic hernia (CDH). Method: Demographic and clinical parameters ofneonates with congenital diaphragmatic heria (n=37) between January 2014 and October,2017 were reviewed, and compared among those who survived or expired in hospital.Result: Median (range) gestation and birthweight were 38 (37-39) weeks and 2496 (2044-2889) g, respectively. Persistent pulmonary hypertension (PPHN) was documented in 19(51%) neonates and 10 (27%) had associated malformations. Surgery could be performed in18 (49%), overall mortality was 60%. On univariate analysis, low Apgar scores, presence ofmalformations, PPHN, need for higher initial peak inspiratory pressure/high frequencyventilation, and requirement of a patch for closure were associated with increased mortality.On multivariate analysis, PPHN remained the only significant risk factor [adjusted RR 3.74(95% CI 1.45-9.68)]. Conclusion: The survival of infants with CDH is low, and PPHN is animportant predictor of mortality.

Postnatal Maturation of Amplitude Integrated Electroencephalography (aEEG) in Preterm Small for Gestational Age Neonates

Objective: The primary objective was to evaluate the postnatal maturation pattern on aEEGduring first two weeks of life in clinically stable and neurologically normal preterm small forgestational age (PSGA) and gestation matched (1 week) preterm appropriate for gestationalage (PAGA) neonates born between 300/7 and 346/7 weeks of gestation. Methods: SerialaEEG tracings were recorded on 3rd, 7th and 14th day of life. The primary outcome wastotal aEEG maturation score. Three blinded assessors assigned the scores. Results: Weanalyzed a total of 117 aEEG recordings in 40 (19 PSGA and 21 PAGA) neonates. Thebaseline characteristics were comparable except for birthweight [1186 (263) vs 1666(230) g]. There was no difference in the mean (SD) total scores on day 3 (9.0 (1.8) vs. 9.5(1.1), P=0.32) and day 14 of life, but was lower in PSGA infants on day 7 (8.6 (2.4) vs. 10.1(1.1), P=0.02). On multivariate analysis, maturation of PSGA neonates was found to besignificantly delayed at any point of life from day 3 to day 14 (mean difference, -0.8, 95 % CI:-1.6 to -0.02, P=0.04). Conclusion: Lower aEEG maturation score on day 7 possiblyindicates delayed maturation in PSGA neonates in the first week of life.

Gains from Quality Improvement Initiatives – Experience from a Tertiary-care Institute in India

Quality improvement (QI) in healthcare involves implementing small iterative changes by a team of people using a simple structuredframework to resolve problems, improve systems, and to improve patient outcomes. These efforts are especially important in a resource-limited setting where infrastructure, staff and funds are meagre. The concept of QI often appears complex to a new careprovider whofeels intimidated to participate in change activities. In this article, we describe our experience with QI activities to address various issuesin the Neonatal intensive care unit. QI efforts resulted in improved patient outcomes, and motivated careproviders. QI is a continuousactivity and can be done easily if the team is willing to learn from their experiences and use those lessons to adapt, adopt or abandonchanges, and improve further. Our institute has also developed Point of Care Quality Improvement (POCQI), a free online resource forlearning the science of QI, and also serves as a platform for sharing QI work.

Target Oxygen Saturation Among Preterm Neonates on Supplemental Oxygen Therapy: A Quality Improvement Study

Objective: To avoid excessive oxygen exposure and achieve target oxygen saturation(SpO2) within intended range of 88%-95% among preterm neonates on oxygen therapy.Methods: 20 preterm neonates receiving supplemental oxygen in the first week of lifewere enrolled. The percentage of time per epoch (a consecutive time interval of 10 hours/day) spent by them within the target SpO2 range was measured in phase 1 followed byimplementation of a unit policy on oxygen administration and targeting in phase 2. In phase 3,oxygen saturation histograms constructed from pulse-oximeter data were used as dailyfeedback to nurses and compliance with oxygen-targeting was measured again. Results:48 epochs in phase 1 and 69 in phase 3 were analyzed. The mean (SD) percent time spentwithin target SpO2 range increased from 65.9% (21.4) to 76.5% (12.6) (P=0.001).Conclusion: Effectiveimplementation of oxygen targeting policy and feedback usingoxygen saturation histograms may improve compliance with oxygen targeting.

Improving Duration of Kangaroo Mother Care in a Tertiary-care Neonatal Unit : A Quality Improvement Initiative

Objectives: To increase the duration of Kangaroo mother care(KMC) in preterm infants from an average of 3 hours/day to atleast 6 hours/day over 7 weeks through a Quality improvement(QI) approach in a tertiary-care neonatal unit.Methods: Preterm mother-infant dyads who were admitted in theNeonatal intensive care unit and KMC ward were enrolled in thisstudy. A QI team comprising of nurses, nurse educators, residentphysicians and nursing-in-charge of unit was formed. Thepotential barriers for prolonged KMC were evaluated using fishbone analysis. A variety of measures (allowing family membersincluding male members during night for doing KMC, makingKMC an integral part of treatment order, introducing the concept ofweekly KMC champions, etc.) were introduced and subsequentlytested by multiple Plan-do-study-act (PDSA) cycles. Data onduration of KMC per day was measured by bedside nurses ondaily basis.Results: 20 eligible mother-infant dyads were studied duringimplementation period (50 d). The mean (SD) weight andgestation of infants were 1199 (356) g and 31.1 ( 2.3) wks,respectively. We achieved our goal by step-wise implementationof changes through construction of 3 PDSA cycles. The durationof KMC increased to 6 hours-a-day over a period of 7 weeks.Evaluation at 6 and 12 months in the post-implementation phasesuggested sustenance of improved KMC duration up to 9 h/day inthe unit.Conclusions: Ongoing quality improvement measures increasedthe duration of KMC from a baseline of 3 h to 6 h in eligible preterminfants, and the results were sustained at 6-12 month.

Assisted Physical Exercise and Stress in Preterm Neonates

Objective: To evaluate the markers of stress before and after a session of assisted physicalexercise in infants born before 35 weeks’ gestation. Methods: 25 infants born at 280/7 to 346/7weeks were subjected to assisted physical exercise daily for about 10-15 min at one week ofpostnatal age or 33 weeks of post menstrual age, whichever was later. Primary outcome wassalivary cortisol and secondary outcome was Premature infant pain profile (PIPP) score.Outcomes were measured, on day 5 (±1) of exercise. Results: There was no difference insalivary cortisol between baseline and immediately after (P=0.16), at 90 min (P=0.6) or 120min (P=0.7) after exercise. Salivary cortisol was lower at 30 min after exercise as compared tobaseline (mean difference -0.08 ?g/dL; 95% CI -0.16 to -0.002; P=0.04). The median (IQR)PIPP score was significantly higher at 5 min into exercise (4 (3-6) vs 4 (3-5); P=0.04) and atcompletion of exercise 6 (4-8) vs 4 (3-5); P<0.01), as compared to baseline. Conclusion:Assisted physical exercise does not seem to result in stress in premature infants

Assisted Physical Exercise for Improving Bone Strength in Preterm Infants Less than 35 Weeks Gestation: A Randomized Controlled Trial

Objective: To compare the efficacy of daily assisted physicalexercise (starting from one week of postnatal age) on bonestrength at 40 weeks of post menstrual age to no intervention ininfants born between 27 and 34 weeks of gestation.Design: Open-label randomized controlled trial.Setting: Tertiary-care teaching hospital in northern India from 16May, 2013 to 21 November, 2013.Participants: 50 preterm neonates randomized to Exercisegroup (n=26) or Control group (n=24).Intervention: Neonates in Exercise group underwent onesession of physical exercise daily from one week of age, whichincluded range-of-motion exercises with gentle compression,flexion and extension of all the extremities with movements ateach joint done five times, for a total of 10-15 min. Infants inControl group underwent routine care and were not subjected toany massage or exercise Outcome measures:Primary: Bone speed of sound of lefttibia measured by quantitative ultrasound at 40 weeks postmenstrual age. Secondary:Anthropometry (weight length andhead circumference) and biochemical parameters (calcium,phosphorus, alkaline phosphatase) at 40 weeks post menstrualage.Results:The tibial bone speed of sound was comparablebetween the two groups [2858 (142) m/s vs. 2791 (122) m/s;mean difference 67.6 m/s; 95% CI - 11 to 146 m/s; P=0.38]. Therewas no difference in anthropometry or biochemical parameters.Conclusion:Daily assisted physical exercise does not affectthe bone strength, anthropometry or biochemical parameters inpreterm (27 to 34 weeks) infants.

Description and Validation of a Novel Method of Measuring Pharyngeal Pressure in New-born.

Study background: Measurement of delivered pharyngeal pressure during continuous positive airway pressure (CPAP) therapy is not in routine practice due to lack of a simple and affordable technique of intrapharyngeal pressure measurement. To overcome the lack of the gold standard solid-state catheter-tip pressure measurement technology in our set up, we improvised a novel method of pressure measurement and tested its validity in a simulated pharynx. Methods: A low-cost pressure transducer was improvised by attaching an orogastric tube to its one end. The other end of the orogastric tube was sealed into an artificial pharynx - a 20 ml syringe. The pressure transducer readings were compared with that obtained by a digital manometer attached to the tip of the syringe. Bland-Altman statistic was used to quantify the measurement reliability of the novel method against the digital manometer. Effect of tube length on the measurement agreement was also studied. The developed technique was applied in new-borns. Results & conclusion: Pressures measured by this technique were in good agreement with that obtained using a digital manometer. This technique has the potential to be used as an alternative to catheter-tip pressure transducers for bedside pharyngeal pressure measurement in new-born babies, especially in underresourced setups.

Feasibility study of a novel intraosseous device in adult human cadavers.

Background & objectives: Intraosseous (IO) access is an alternative to difficult intravenous (iv) access during emergency clinical situations. Existing IO solutions are expensive, require power supply and trained manpower; limiting their use in resource constrained settings. To address these limitations, a novel IO device has been developed. The objectives of this study were to evaluate functionality and safety of this device in adult human cadavers. Methods: The ability of the IO device to penetrate the proximal and/or distal tibia was evaluated in three adult cadavers. Subjective parameters of loss of resistance, stable needle hold, easy needle withdrawal and any damage to the device were evaluated during the study. The insertion time was the objective parameter measured. Four sets of radiographs per insertion confirmed the position of the needle and identified complications. Results: A single physician performed 12 IO access procedures using the same device. Penetration of proximal and/or distal tibia was achieved in all instances. It was successful in the first attempt in eight (66.7%) and during second attempt in the remaining. The mean time to insertion was 4.1 ± 3.1 sec. Appropriate insertion of needle in the intra-medullary space of bone was confirmed with radiological examination in 10 (83.3%) insertions. In two occasions after penetrating the cortical layer of bone, the device overshot the intra-medullary space, as detected by radiological examination. Device got bent during insertion in one instance. There was no evidence of needle breakage or bone fracture. The needle could be withdrawn effortlessly in all instances. Interpretation & conclusions: The novel IO device could successfully penetrate the adult cadaver bones in most cases. Further studies are needed to confirm these results on a large sample.

Predictors of Breastfeeding Problems in The First Postnatal Week and Its Effect on Exclusive Breastfeeding Rate at Six Months: Experience in A Tertiary Care Centre in Northern India.

In spite of the countless benefi ts of breastfeeding, prevalence of exclusive breastfeeding (EBF) has been far from optimal in the developing world. Breastfeeding problems at or after 4 weeks has been reported as one among the constraints to EBF. The study aimed to determine the breastfeeding problems in the 1st postnatal week, their predictors and impact on EBF rate at 6 months. Under a prospective cohort design, 400 mother-newborn dyads were assessed for breastfeeding problems before discharge and at 60 ± 12 h of discharge. Nearly 89% of the mother-newborn dyads had one or more BF problems before discharge. Major concern was diffi culty in positioning and attaching the infant to the breast (88.5%), followed by breast and nipple problems (30.3%). BF problems continued to persist even after discharge in a signifi cant proportion of the mothers (72.5%). The only independent predictor of BF problems in the 1st week was the caesarean section (odds ratio: 1.9, 95% confi dence interval: 1.3-3.2, P < 0.05). There was a marked improvement in the EBF status (69.5%) at 6 months, and BF problems did not predict EBF failure at 6 months.

Development and validation of oral health-related early childhood quality of life tool for North Indian preschool children.

Objective: The purpose of this study was to develop a reliable instrument [Oral Health related Early Childhood Quality of Life (OH- ECQOL) scale] for measuring oral health related quality of life (OHrQoL) in preschool children in North Indian population. Methodology: Four pediatric dentists evaluated a pool of 65 items from various QoL questionnaires to assess their relevance to Indian population. These items were discussed with eight independent pediatric dentists and two community dentists who were not a part of this study to assess relevance of these items to preschool age children based on their comprehensiveness and clarity. Based on their responses and feedback a modified pool of items was developed and administered to a convenience sample of 20 parents who rated these items according to their relevance. The test retest reliability was evaluated on another sample of 20 parents of 2-5 year old children. The final questionnaire comprised of 16 items (12 child and 4 family). This was administered to 300 parents of 24-71 months old children divided on the basis of early childhood caries to assess its reliability and validity. Results: OH-ECQOL scores were significantly associated with parental ratings of their child's general and oral health, and the presence of dental disease in the child. Cronbach's alpha was 0.862, and the ICC for test-retest reliability was 0.94. Conclusions: The OH-ECQOL proved reliable and valid tool for assessing the impact of oral disorders on the quality of life of preschool children in Northern India.

Vitamin A Status of Low and Normal Birth Weight Infants at Birth and in Early Infancy.

Serum retinol levels of low birth weight (LBW; birth weight <2500g) and normal birth weight (NBW; birth weight ≥2500g) infants were evaluated at birth and 3 months using high performance liquid chromatography. At birth, levels were 13.3±8.2 μg/dL in LBW (n=146) and 14.0±6.2 μg/dL in NBW infants (n=79; p=0.51), with 41.1% of LBW and 24.1% of NBW infants having vitamin A deficiency (VAD, <10 μg/dL; P=0.01). At follow up, levels were 18.0±9.4 μg/dL in LBW (n=83) and 20.0±7.3 μg/dL in NBW infants (n=51; P=0.19), with 18.1% of LBW and 3.9% of NBW infants having VAD (P=0.02).

ASHA’s Involvement in Newborn Care: A Feasibility Study.

We assessed the feasibility of involvement of Accredited Social Health Activist (ASHA) in newborn care. All the ASHAs (n = 33) of PHC Dayalpur, Faridabad district of Haryana were trained for one day which was followed by two refresher trainings. The mean (SD) knowledge score (out of 11) of ASHAs were 6.45 (2.44), 6.50 (2.01), 7.45 (1.36) and 7.15 (1.27) at pre-training, immediately after training, and after three and six months, respectively. Four fifth (83%) of the newborns born at home were weighed within 3 days of birth. About half (44%) of ASHAs weighed the neonates within ±250 grams of the weight recorded by the author. We conclude that ASHAs could be involved in providing care for newborn. However, such efforts should ensure a stronger focus on skill development and practical experience.

Evaluation of Phototherapy Devices Used for Neonatal Hyperbilirubinemia.

Objective: To compare phototherapy devices based on their physical and photo-biological characteristics viz spectral properties, maximum and mean irradiance, treatable percentage of body surface area, decay of irradiance over time and in vitro photoisomerisation of bilirubin. Design: In vitro experimental study. Setting: Ocular pharmacy laboratory at a tertiary care hospital. Methodology: All the characteristics were measured at a fixed distance of 35 cm from one compact fluorescent lamp (CFL) and three light emitting diode (LED) phototherapy devices in a dark room with an irradiance of <0.1μW/cm2/nm. Estimation of products of in vitro photoisomerisation was done using liquid chromatography - tandem mass spectroscopy (LC-MS/ MS). Results: The emission spectral data were comparable between the phototherapy devices. The devices, however, differed in their maximum irradiance with the spot and indigenous LED units having the highest and lowest values, respectively (56.5 and 16.8μW/cm2/nm). The mean irradiance – measured in 5x5cm grids falling within the silhouette of a term baby – of the spot and improvised LED devices were low (26.8μW/cm2/nm and 11.5μW/cm2/ nm, respectively) possibly due to unevenness in the irradiance of light falling within the silhouette. There was a significant difference in the amount of bilirubin left after exposure to light over a 2-hour time period (% reduction of bilirubin) among the four devices (P=0.001); at 120 minutes after exposure, the amount of bilirubin left was lowest for the CFL (16%) and spot LED (17%) devices and highest for the indigenous LED unit (41%). Conclusions: The four phototherapy devices differed markedly in their physical and photobiological characteristics. Since the efficacy of a device is dependent not only on the maximum irradiance but also on the mean irradiance, rate of decay of irradiance, and treatable surface area of the foot print of light, each phototherapy device should have these parameters verified and confirmed before being launched for widespread use.

Vitamin D deficiency in healthy breastfed term infants at 3 months & their mothers in India: Seasonal variation & determinants.

Background & objectives: Vitamin D deficiency with a resurgence of rickets and tetany are increasingly being reported in young infants from temperate regions, African Americans and also from India. The data on vitamin D status of healthy term breastfed Indian infants and mothers are scant. Therefore, we undertook this study to determine the prevalence of vitamin D deficiency and insufficiency [serum 25 hydroxyvitamin D (25OHD) ≤ 15 ng/ml and 15-20 ng/ml, respectively] among healthy term breastfed 3 month old infants and their mothers, evaluate for clinical and radiological rickets in those infants having 25OHD < 10 ng/ml, and check for seasonal variation and predictors of infants’ vitamin D status. Methods: A total of 98 infants aged 2.5 to 3.5 months, born at term with appropriate weight and their mothers were enrolled; 47 in winter (November- January) and 51 in summer (April-June). Details of infants’ feeding, vitamin D supplementation, sunlight exposure and mothers’ calcium and vitamin D intake were recorded. Serum calcium, phosphate, alkaline phosphatase, 25 hydroxyvitamin D (25OHD) and parathormone were estimated. Results: Vitamin D deficiency was found in 66.7 per cent of infants and 81.1 per cent of mothers; and insufficiency in an additional 19.8 per cent of infants and 11.6 per cent of mothers. Radiological rickets was present in 30.3 per cent of infants with 25OHD < 10 ng/ml. 25OHD did not show seasonal variation in infants but maternal concentrations were higher in summer [11.3 (2.5 - 31) ng/ml] compared to winter [5.9 (2.5-25) ng/ml, P=0.003]. Intake of vitamin supplement, sunlight exposure and mother’s 25OHD were predictors of infants’ 25OHD levels. Interpretation & conclusions: Prevalence of vitamin D deficiency and insufficiency was found to be high in breastfed infants and their mothers, with radiological rickets in a third of infants with 25OHD < 10 ng/ml in this study. Studies with large sample need to be done in different parts of the country to confirm these findings.

Management of Neonatal Seizures.

Seizures in the newborn period constitute a medical emergency. Subtle seizures are the commonest type of seizures occurring in the neonatal period. Myoclonic seizures carry the worst prognosis in terms of long-term neurodevelopmental outcome. Hypoxic-ischemic encephalopathy is the most common cause of neonatal seizures. Multiple etiologies often co-exist in neonates and hence it is essential to rule out common causes such as hypoglycaemia, hypocalcemia, and meningitis before initiating specific therapy. A comprehensive evidence based approach for management of neonatal seizures has been described in this protocol.

Hypocalcemia in the Newborn.

Hypocalcemia is a frequently observed clinical and laboratory abnormality in neonates. Ionic calcium is crucial for many biochemical processes including blood coagulation, neuromuscular excitability, cell membrane integrity, and many of the cellular enzymatic activities. Healthy term infants undergo a physiological nadir in serum calcium levels by 24-48 h of age. This nadir may drop to hypocalcemic levels in high-risk neonates including infants of diabetic mothers, preterm infants and infants with perinatal asphyxia. The early onset hypocalcemia which presents within 72 h requires treatment with calcium supplementation for at least 72 h. In contrast, late onset hypocalcemia usually presents after 7 days and requires longer term therapy.