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Background: Neonatal resuscitation is a critical process for a newborn with effective ventilation as its key component. Three manual ventilation devices, including self-inflating bags (SIB), flow-inflating bags (FIB), and T-piece resuscitator (TPR) are recommended for positive pressure ventilation (PPV) in the delivery room. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns. This study is planned to compare the effectiveness of TPR and SIB during resuscitation. Methods: This will be a single centre, open-label, randomized controlled trial. Study participants will be preterm ?34 of gestation needing PPV at birth as per NRP algorithm. Newborns will be randomly assigned to two groups (TPR or SIB). SpO2 at 2 and 5 min, time to reach heart rate >100/min by pulse oximetry, and duration of PPV will be recorded. Primary outcome is need of delivery room intubation. Intention to treat analysis will be done using STATA version 17.0. A priori defined subgroup for purpose of analysis will be gestation ?30 and 31-34 weeks. Trial will be done as per good clinical practice guidelines. Conclusions: If PPV with TPR is proven to be more efficacious in terms of less delivery room intubation, there would be a way towards finalizing the TPR as primary device for providing PPV during delivery room resuscitation at birth. This study has potential to bring down need of delivery room intubation with less duration of mechanical ventilation and morbidity in form of IVH, BPD and composite outcome of BPD and death. Trial registration: CTRI number: CTRI/2023/01/048660.
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Dengue infection is possible in all the three trimesters of pregnancy and is associated with various maternal and neonatal complications. The occurrence of subclinical infections may lend further confusion to the situation. Here, we report a case of neonatal dengue diagnosed with dengue NS1 antigen positive and IgM positive followed by secondary sepsis with Enterococcus faecium. Case studies like these may contribute to increased awareness of the suspicion of the associated life-threatening infections that can occur with neonatal dengue, their manifestations, and the management, thus improving their outcome.
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Objective: To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications. Methods: Chart audit in neonatal intensive care units of two institutions in Chandigarh, India. Results: Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% prescriptions were off-label for frequency, dose, indication, route or rate. Most common off-label drugs were anti-infective and antiepileptic. Despite lack of regulatory approval, one-third off-label drugs had level I-II evidence of safety and efficacy for use in neonates. Conclusion: Use of off-label drugs is common in sick neonates.
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Objectives: (i) To construct hour-specific serum total bilirubin (STB) nomogram in neonates born at ≥35 weeks of gestation; (ii)To evaluate efficacy of pre-discharge bilirubin measurement in predicting hyperbilirubinemia needing treatment. Design: Diagnostic test performance in a prospective cohort study. Setting: Teaching hospital in Northern India. Subjects: Healthy neonates with gestation ≥35 weeks or birth weight ≥2000 g. Intervention: Serum total bilirubin was measured in all enrolled neonates at 24±6, 72-96 and 96-144 h of postnatal age and when indicated clinically. Neonates were followed up during hospital stay and after discharge till completion of 7th postnatal day. Outcome: Key outcome was significant hyperbilirubinemia (SHB) defined as need of phototherapy based on modified American Academy of Pediatrics (AAP) guidelines. In neonates born at 38 or more weeks of gestation middle line and in neonates born at 37 or less completed weeks of gestation, lower line of phototherapy thresholds were used to initiate phototherapy. For construction of nomogram, STB values were clubbed in six-hour epochs (age ± 3 hours) for postnatal age up to 48 h and twelvehour epochs (age ± 6 hours) for age beyond 48 h. Predictive ability of the nomogram was assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio, by plotting receiver-operating characteristics (ROC) curve and calculating c-statistic. Results: 997 neonates (birth weight: 2627 ± 536 g, gestation: 37.8±1.5 weeks) were enrolled, of which 931 completed followup. Among enrolled neonates 344 (34.5%) were low birth weight. Rate of exclusive breastfeeding during hospital stay was more than 80%. Bilirubin nomogram was constructed using 40th, 75th and 95th percentile values of hour-specific bilirubin. Pre-discharge STB of ≥95th percentile was assigned to be in high-risk zone, between 75th and 94th centile in upper-intermediate risk zone, between 40th and 74th centile in lower-intermediate risk zone and below 40th percentile in low-risk zone. Among 49 neonates with pre-discharge STB in high risk zone. 34 developed SHB (positive predictive value: 69.4%, sensitivity: 17.1%, positive likelihood ratio: 8.26). Among 342 neonates with pre-discharge STB in low risk zone, 32 developed PHB (negative predictive value: 90.6% and specificity: 42.5%, positive likelihood ratio: 0.37). Area under curve for this risk assessment strategy was 0.73. Conclusion: Hour-specific bilirubin nomogram and STB measurement can be used for predicting subsequent need of phototherapy. Further studies are needed to validate performance of risk demarcation zones defined in this hour-specific bilirubin nomogram.
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Objectives: To evaluate the clinical, behavioral and health-care associated risk factors of intrapartum perinatal mortality (IPPM). Design: Prospective cohort study. Setting: Labor room and postnatal wards of a teaching hospital in North India. Participants: Pregnant women were eligible for enrolment in the study if period of gestation at delivery was 35 weeks or more or baby weighed at least 2000 g at birth, index pregnancy was not booked in antenatal clinic of the study hospital and fetus was delivered within 24 h of admission in the hospital. Methods: Information about antenatal care and events surrounding labor and delivery were retrieved from antenatal care records, referral notes, hospital clinical records and interview of mothers. Multivariate analysis was conducted using forward stepwise logistic regression analysis. Main Outcome Measure: IPPM was defined as asphyxiaspecific stillbirth or asphyxia-specific early neonatal death. Results: Among 248 emergency obstetric referrals during the study period, rate of IPPM was 8% (20/248, 18 fresh stillbirths and 2 asphyxia-specific neonatal deaths). District hospitals and community health-centers/first referral units contributed threefourths of all referrals. On logistic regression analysis significant risk factors for IPPM were presence of obstructed labor (OR: 23, 95% CI: 1.9-275.8), father engaged in unskilled labor (OR: 10, 95% CI: 1.3-77.7) and absence of urine examination during antenatal period (OR: 5.5, 95% CI: 1.8-16.3). Conclusions: Low socioeconomic status, inadequate antenatal care and poor intrapartum care due to unskilled birth attendance are risk factors of IPPM.
Subject(s)
Anti-Bacterial Agents/pharmacology , Bacteremia/diagnosis , Bacteremia/microbiology , Bacteremia/pathology , Fatal Outcome , Humans , Infant , Male , Salmonella Infections/diagnosis , Salmonella Infections/microbiology , Salmonella Infections/pathology , Salmonella typhimurium/enzymology , Salmonella typhimurium/isolation & purification , beta-Lactam Resistance , beta-Lactamases/biosynthesis , beta-Lactams/pharmacologyABSTRACT
Objective To establish newborn screening in Indian scenario that could lay a framework for future such initiatives. Three disorders namely, congenital hypothyroidism (CH), congenital adrenal hyperplasia (CAH) and glucose-6- phosphate dehydrogenase deficiency (G-6-PDD) were selected for a preliminary study for newborn screening. Methods Heel-prick blood samples were collected from liveborn neonates at 24–48 h of birth as a part of a screening program after prior written consent from the parents. Blood levels of glucose-6-phosphate-dehydrogenase enzyme (G-6- PD), thyroid-stimulating hormone (TSH) and 17-α-OH progesterone (17-OHP) were measured using DELFIA time resolved fluoroimmunoassay. Results Six thousand eight hundred and thirteen (6,813) neonates (86.3%), out of a total of 7,893 live births in our institute during the period May’2007 through July’2009, were screened for CAH, CH and G6PD deficiency. Major reason for missing samples was early discharge of the neonates and admission to the neonatal intensive care unit. G-6-PD deficiency was confirmed in 61 cases, congenital hypothyroidism (CH) in 2 cases and congenital adrenal hyperplasia (CAH) in 1 neonate, accounting for an incidence of 1/112 for G-6-PDD, 1/ 3400 for CH and 1/6813 for CAH. Conclusions Preliminary data on prevalence of various genetic disorders viz. G-6-PDD, CH and CAH in the population of this region revealed that G-6-PDD is most prevalent disorder followed by CH and CAH. More efforts need to be undertaken to create awareness and emphasis on significance of preventive testing to make screening a successful program in India.
Subject(s)
Adrenal Hyperplasia, Congenital/diagnosis , Adrenal Hyperplasia, Congenital/epidemiology , Congenital Hypothyroidism/diagnosis , Congenital Hypothyroidism/epidemiology , Female , Glucosephosphate Dehydrogenase Deficiency/diagnosis , Glucosephosphate Dehydrogenase Deficiency/epidemiology , Humans , Incidence , India , Infant, Newborn , Male , Neonatal Screening/methods , Sensitivity and Specificity , Severity of Illness Index , Sex FactorsSubject(s)
Attitude to Health , Female , Humans , India , Infant, Newborn , Mothers , Neonatal Screening , Parental Consent , Patient Selection , Prospective StudiesABSTRACT
This study was conducted to determine the incidence and magnitude of postphototherapy bilirubin rebound in neonates. Subjects included inborn neonates needing phototherapy for hyperbilirubinemia. Standard guidelines were used to start and stop phototherapy. Rebound bilirubin was measured 24±6 h after stopping phototherapy. Significant bilirubin rebound (SBR) was defined as postphototherapy bilirubin level needing reinstitution of phototherapy. Among 245 neonates with hyperbilirubinemia, post-phototherapy bilirubin estimation was done in 232 neonates. A total of 17 (7.3%) neonates developed SBR. In neonates with SBR, bilirubin increased by 2.3 mg/dL (95% CI 1.6-3.0) after stopping phototherapy. Risk factors for SBR included birth at <35 weeks of gestation (RR 4.3, 95% CI 1.5-12.0), birthweight <2000 g (RR 3.2, 95% CI 1.0-10.3) and onset of jaundice at <60 h of age (RR 3.3, 95% CI 1.2-9.0). Post-phototherapy discharge and follow-up planning should take into account these risk factors.
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Background : Medication is the most common health-care intervention, and the errors arising out of its usage are potentially an avoidable cause of iatrogenic injuries. There are reports of medication errors from neonatal emergency setups. Aims : To study the medication errors of ordering, dispensing and administering in neonates admitted for emergency care and to compare the errors occurring in the emergency department (ED) with those occurring in the neonatal intensive care unit (NICU) of a teaching hospital in north India. Primary objective: To study the medication errors in ordering and dispensing for neonates. Secondary objective: To compare these errors in 2 different settings - ED and NICU. Materials and Methods : We did a retrospective chart review of neonatal prescriptions written in the 4 months from January to April 2004 in the neonatal intensive care unit and the pediatric emergency department. The prescriptions were analyzed from the case records bearing an even registration number, obtained from the hospital 'medical records' section. Medication error was defined as 'any preventable event that occurs in the process of ordering, transcribing, dispensing, administering or monitoring a drug irrespective of whether the injury occurred or potential for injury was present.' Results : A total of 821 prescriptions were analyzed and 81 (9.6%) errors were detected. The error rate was found to be 1.5 (54/38) and 0.7 (27/38) per patient in ED and NICU, respectively, being highly significant in ED. Every tenth prescription had medication error in ordering or dispensing; of this, every sixth prescription in ED and nineteenth prescription in NICU had medication error. Dosing errors were the commonest form of detected errors. None of the errors caused any significant harm to the patient but had the potential to cause severe injury, and majority of these errors were preventable. Conclusion : Medication errors are common in neonatology; more so, in emergency departments than in the neonatal intensive care units.
Subject(s)
Emergency Service, Hospital/statistics & numerical data , Hospitals, Teaching/statistics & numerical data , Humans , India , Infant, Newborn , Intensive Care Units, Neonatal/statistics & numerical data , Intensive Care, Neonatal/statistics & numerical data , Medication Errors/statistics & numerical data , Retrospective Studies , Emergency Service, Hospital/statistics & numerical data , Hospitals, Teaching/statistics & numerical data , Humans , India , Infant, Newborn , Intensive Care Units, Neonatal/statistics & numerical data , Intensive Care, Neonatal/statistics & numerical data , Medication Errors/statistics & numerical data , Retrospective StudiesABSTRACT
OBJECTIVE: To study the feasibility and acceptability of Kangaroo mother care (KMC) on the low birth weight infants (LBWI) in the neonatal intensive care unit (NICU) by the mothers, family members and health care workers (HCW) and to observe its effect on the vital parameters of the babies. METHOD: A observation in the NICU. RESULTS: A total of 135 babies (74 boys and 61 girls) who completed minimum of 4 hrs of KMC/day, were included. The mean birth weight and gestation were 1460 gm and 30 week respectively. 47% babies started KMC within first week of age. Mean duration of KMC was 7 days (3-48) days. The O(2) saturation improved by 2-3%, temperature ( degrees C) rose from 36.75 +/- 0.19 to 37.23 +/- 0.25, respiration stabilized (p<0.05 for all) and heart rate dropped by 3-5 beats. No episodes of hypothermia or apnea were observed during KMC. KMC was accepted by 96 % mothers, 82% fathers and 84% other family members. 94% HCW considered it to be safe and conservative method of care of LBWI. Benefits of KMC on the babies' behavior and on maternal confidence and lactation were reported by 57%, 94% and 80% respectively. A decline in use of heating devices in the NICU was reported by 85% and 79% said it did not increase their work load. CONCLUSION: KMC was found to be safe, effective and feasible method of care of LBWI even in the NICU settings. Positive attitudes were observed in mothers, families and HCW.