Impact of hypothermia alert device (BEMPU) on improvement of duration of Kangaroo Mother Care (KMC) provided at home: parallel-group randomized control trial.

The objective of the study was to determine if using the hypothermia-detecting bracelet (named BEMPU) improves the duration of Kangaroo Mother Care (KMC) at home by one hour. This parallel-group randomized controlled trial was conducted at a step-down nursery of a teaching hospital. Neonates between 1000 and 2000 g were randomized to BEMPU and control groups at the time of discharge. BEMPU was applied at the wrist of each newborn in the BEMPU (intervention) group. Parents were advised to keep the BEMPU in place till 4 weeks post-discharge. The BEMPU generates a beep sound as an alarm when a newborn's temperature drops below 36.5 °C. Parents in both groups were trained to provide KMC at home. Parents in the BEMPU group received the "KMC chart" and "BEMPU beep chart," while the control group received the "KMC chart" only. In the "KMC chart," parents entered information about KMC hours on a real-time basis, and in the "BEMPU beep chart," they entered information about alarm beeps from BEMPU on a real-time basis till 4 weeks post-discharge. Independent samples t-test was used to compare mean KMC hours between the two groups. A total of 128 neonates participated in the study (64 in BEMPU and 64 in Control groups). The mean(SD) gestational age for the BEMPU group was 34.04(2.84) weeks vs 34.75(2.70) weeks for the control group. In BEMPU group, mean(SD) daily time spent doing KMC was significantly higher in 1st week [4.78(2.93) vs. 3.22(2.44) h, p = 0.003], in 2nd week [4.52(3.43) vs. 2.84(2.95) h, p = 0.008], in 3rd week [4.23(3.71) vs. 2.30(2.70) h, p = 0.003], in 4th week [3.72(3.30) vs. 1.95(2.65) h, p = 0.003] as compared to control group. BEMPU improved the daily duration of KMC hours at home compared to the control group over four weeks. Clinical Trial Registration: This trial is registered at Clinical Trials Registry India with registration number: CTRI/2018/08/015154 and accessible at http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=27600&EncHid=&modid=&compid=%27,%2727600det%27 Registered on 01/08/2018.

Evaluation of Pulse Rate, Oxygen Saturation, and Respiratory Effort after Different Types of Feeding Methods in Preterm Newborns.

Background: During the initial days of hospitalization, preterm newborns are given combinations of breastfeeding, spoon/paladai feeding, and/or gavage feeding. Each method of feeding may have a different effect on vital parameters. Objective: To study changes in vital parameters in relation to different feeding methods and postmenstrual age (PMA) in preterm newborns. Study Design. This prospective observational study was carried out at a tertiary care neonatal unit. Participants. Physiologically stable preterm newborns with PMA less than 37 weeks on full enteral feeds were included in the study. Intervention. None. Outcomes. Respiratory rate (RR), pulse rate (PR), oxygen saturation (SPO2), nasal flaring, and lower chest indrawing were monitored before and up to 3 h after the breastfeeding/spoon (paladai) feeding/gavage feeding or their combinations. These vital parameters were assessed in relation to the feeding methods and PMA groups using ANOVA. Results: A total of 383 records were analyzed from 110 newborns. No infant developed chest indrawing or nasal flaring after any feeding method. During the 3 h period of monitoring, vital parameters changed significantly except in the gavage feeding group. The mean PR did not change, but the mean RR and SPO2 changed significantly at different PMA. Conclusion: Vital parameters changed after different types of feeding methods and at different PMA. A further multicentric prospective study is needed to understand the effect of different feeding methods and PMA on vital parameters.

Skin-to-Skin Care by Mother vs. Father for Preterm Neonatal Pain: A Randomized Control Trial (ENVIRON Trial).

OBJECTIVE: To compare skin-to-skin care (SSC) given by mother and father for preterm neonatal pain control by premature infant pain profile (PIPP) score. METHODS: 64 stable preterm (28-36 weeks gestational age) neonates born at a level-3 neonatal intensive care unit were included in the trial. Random allocation with the help of a computer-generated sequence was done. In group A, SSC was given by the mother 15 minutes before the first heel-stick, and subsequently, SSC was given by the father before the second heel-stick. In group B, the sequence of SSC provider was reversed. Blinded PIPP score assessment at 0, 1, and 5 minutes of heel-stick were done by two independent assessors using video recording. RESULTS: The mean (SD) birth weight was 1665.18 (339.35) grams, and mean (SD) gestational age was 34.28 (2.24) weeks. The PIPP score at 0, 1, and 5 minutes had no statistical or clinically significant differences between both groups (PIPP score mean (SD) at 0 minute = 3.20 (1.11) vs. 3.01 (1.29), p value = 0.38; 1 minute = 8.59 (4.27) vs. 8.26 (4.08), p value = 0.66; 5 minutes = 3.79 (1.40) vs. 3.93 (1.99), p value = 0.65 in SSC by mother and father group, respectively). Furthermore, there was no statistical difference between the groups for any components of the PIPP score (all p values > 0.05). The PIPP score at 5 minutes almost attained the 0-minute level in both the groups. CONCLUSION: Father is as effective as the mother for providing skin-to-skin care for preterm neonatal pain control. This trial is registered with CTRI/2018/01/016783.

Embrace versus Cloth Wrap in preventing neonatal hypothermia during transport: a randomized trial.

BACKGROUND: We assessed the efficacy of Embrace Nest Infant Warmer versus Cloth Wrap in preventing hypothermia during short-term transport from the emergency department (ED) to the neonatal intensive care unit (NICU). METHODS: Neonates weighing ≥1500 g coming to the ED were randomized for transport to the NICU. Axillary temperature was measured. RESULTS: A total of 120 newborns (60 per group) were enrolled. From ED exit to NICU entry, the mean (SD) temperature increased in the Embrace group by 0.37 °C (0.54), whereas it reduced by 0.38 °C (0.80) in the Cloth group (p < 0.001). Hypothermia cases reduced in the Embrace group from 39 (65%) to 21 (35%), while it increased from 21 (35%) to 39 (65%) in the Cloth group (p = 0.001) from ED exit to NICU entry. The thermoregulation for 24 h after admission to the NICU was superior in the Embrace group. CONCLUSIONS: Embrace showed significantly better thermoregulation in neonates. Further studies should be done to measure its effectiveness in different environments and distances.

Clinical Profile and Outcome of Newborns with Acute Kidney Injury in a Level 3 Neonatal Unit in Western India.

INTRODUCTION: Acute Kidney Injury (AKI) is a serious condition in neonatal care. It complicates the management necessitating the restrictive use of medications. AIM: To evaluate clinical profile, identify associated and prog-nostic factors in newborns with AKI. MATERIALS AND METHODS: This was a case control study done between January 2008 to January 2010. Total 1745 newborns were admitted, of which 74 babies had AKI. It was defined as serum creatinine >1.5mg/dl. Control group was selected randomly from the hospital numbers of the newborns derived from the electronic registry with serum creatinine below 1.5 mg/dl. Demographic variables like birth weight, gender, gestational age, admission age, growth restriction, Apgar scores, electrolyte levels; and common clinical conditions like asphyxia, sepsis, meningitis, persistent pulmonary hypertension, Necrotizing Enterocolitis (NEC), mechanical ventilation, congenital heart disease; were compared amongst the two groups. Information was obtained from the admission register, admission files, labor register of obstetrics and gynaecology department and electronic registry. Chi square/independent sample t-test as applicable and logistic regression were used to establish an association of various factors and outcome with AKI. RESULTS: The incidence of AKI in our study was 4.24%. Demographic variables more common in AKI group were inborn (p=0.011), male gender (p=0.032), term gestation (p=0.001), Appropriate for gestational age (0.001), higher birth weight (p<0.001), full term (p<0.001), sepsis (p<0.001), NEC (p=0.042), low ApGAR scores at one minute (p=0.011) and five minute (p=0.003). However, on multivariate logistic regression only male gender [Odds Radio (OR)=2.84, Confidence Interval (CI)=1.12-7.21] and Sepsis (OR=14.46, CI=4.5-46.46) were associated with AKI. Respiratory distress syndrome was more prevalent in the control group (p<0.003). No need of mechanical ventilation and absence of shock, improved the survival. CONCLUSIONS: AKI continues to be of clinical significance in neonatal intensive care. Further studies are needed to evaluate newer associations (like male gender and low APGAR scores).

Educational intervention to improve intravenous cannulation skills in paediatric nurses using low-fidelity simulation: Indian experience.

INTRODUCTION: Inserting, monitoring and maintaining intravenous access are essential components of nursing. We evaluated simulation training on a manikin to improve cannulation skills. METHODS: Nursing staff managing paediatric patients were asked to cannulate NITA Newborn-1800 manikin before and after appropriate training. Skills were assessed by a single assessor using an objective structured clinical examination (OSCE) checklist. Four steps were identified as critical. A score of 8/10 (80%) was considered satisfactory. Knowledge was assessed by 10 questions. A training module consisting of theoretical aspects, PowerPoint presentations, videos and hands on training over a manikin was conducted. Post-training assessment was done 1 week later. RESULTS: Seventy-five (80.6%) nurses who completed preassessments and postassessments were assessed for paired comparisons of knowledge and skill. The majority of the nurses were females, had contractual appointment, were in their early career phase and from the paediatric wards. The mean (SD) post-training knowledge score was greater vis-a-vis pretraining score (7.52 (1.58) vs 5.32 (1.57), P<0.001). A similar result was observed for total OSCE scores (9.22 (0.66) vs 7.91 (1.11), P<0.001). Significantly higher proportion of participants exhibited intravenous cannulation satisfactorily after the training vis-a-vis pretraining assessment (69 (92%) vs 36 (48%), P<0.001). CONCLUSION: Training using manikin showed improvement in post-training score of intravenous cannulation skill of paediatric nurses; however, this finding needs further confirmation by a randomised control trial, as our study does not have a control group.

Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

OBJECTIVE: Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study. METHODS: After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return. RESULTS: Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children. CONCLUSION: The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.

Infant and Young Child Feeding Practices in Infants Receiving Skin to Skin Care at Birth: Follow-up of Randomized Cohort.

INTRODUCTION: Skin to Skin Care (SSC) in neonatal period influences immediate breastfeeding outcomes in early childhood, especially the duration of exclusive breastfeeding. AIM: We investigated influence of 17 hours of SSC given from day one of life on Infant and Young Child Feeding (IYCF) practices through one year of life. MATERIALS AND METHODS: Follow-up of a Superiority Randomized Control Trial (RCT) (CTRI/2013/06/003790) conducted in a teaching hospital located in central Gujarat. Mothers of 100 neonates (48 girls, 52 boys) from previous study cohort of RCT on SSC were followed. A survey on IYCF practices during the first year of life was administered after the end of infancy. In RCT, 50 neonates had received SSC beginning of 30 min- 1 hour after birth for average 17 hours on day 1 of life. In the control group, 50 newborn were placed next to the mother and conventional care was provided. There was a significant difference between hypothermia incidences in these groups in the first two days of life. RESULTS: There was no difference in the groups as far as the duration of exclusive breastfeeding, number of times breastfed per day, or stoppage of night feeds. No baby in either group received bottled feeds but about 53 received some form of extra lacteal feeds in the first 6 months without significant group difference. Fewer SSC mothers reported difficulties with breastfeeding or extra lacteal supplementation. All mothers who faced problems contacted physicians for advice and 20 were advised top milk and 6 given other foods. At one year of life 66% mothers were giving less than the recommended five food servings. There was no difference in practices related to hand washing, food preparation and storage, feeding habits of child and illness episodes in the children. CONCLUSION: IYCF practices in this small group were not as per guidelines. Few positive trends were seen with fewer SSC mothers facing problems related to breastfeeding. The study was underpowered to detect differences in IYCF practices in relation to SSC.

Tracheal Agenesis with Tracheo-oesophageal Fistula.

Tracheal Agenesis (TA) presents with respiratory distress at birth. Diagnosis requires recognition of clinical signs in newborns like failure of endotracheal intubation, respiratory distress with absent air entry over both side of chest and inaudible cry. We describe a TA Floyd Type I with a Tracheo-Oesophageal Fistula (TOF) without other congenital malformations.

Near fatal case of amlodipine poisoning in an infant.

An 11-mo-old infant received 12.5 times the maximum therapeutic dose of amlodipine as a result of a medication error in lieu of amoxicillin. He presented with vomiting, lethargy, breathlessness, muffled heart sounds and progressed to hypotensive shock within three hours of admission. He received mechanical ventilation, fluid therapy with normal saline and inotropes. But his parameters improved rapidly only after initiating him on insulin and dextrose infusion therapy (for 15 h) along with glucagon and calcium gluconate infusion (for 72 h). Calcium channel blockers (CCB) cause impaired insulin secretion causing hyperglycemia. High levels of blood sugar are of prognostic value rather than hemodynamic variables in CCB poisoning. A continuous infusion of 0.5 to 1 unit per kg body weight per hour of insulin along with supportive therapy including peritoneal dialysis (for deranged renal function) was used with success in managing amlodipine poisoning.