Exploring magnesium myristate for its dual functionality as a binder and lubricant in the formulation of tablet.

Purpose: To explore 'magnesium myristate' for its dual functionality as a lubricant and binder in the formulation of tablets. Methods: Using (DoE), tablet formulations using magnesium myristate and conventional excipients (magnesium stearate and PVP K30) were developed by wet granulation technique. The prepared granules and formulated tablets were evaluated for pre- and post-compression parameters, respectively. Results: Magnesium myristate exhibited excellent flow properties. The optimized formulations containing magnesium myristate exhibited increased hardness and in vitro drug release in comparison to conventional excipients. f2 similarity index for in vitro drug release showed no significant variations with optimized formulations and with the marketed formulations. Conclusion: Magnesium myristate shows a promising replacement for conventional excipients as both a lubricant and binder in tablet formulation.

Pharmacokinetics of AAV9 Mediated Trastuzumab Expression in Rat Brain Following Systemic and Local Administration.

INTRODUCTION: Recombinant adeno-associated viruses(rAAVs) are an attractive tool to ensure long-term expression monoclonal antibody(mAb) in the central nervous system(CNS). It is still unclear whether systemic injection or local CNS administration of AAV9 is more beneficial for the exposure of the expressed mAb in the brain. Hence, we compared the biodistribution and transgene expression following AAV9-Trastuzumab administration through different routes. METHODS AND RESULT: In-house generated AAV9-Trastuzumab vectors were administered at 5E+11 Vgs/rat through intravenous(IV), intracerebroventricular(ICV), intra-cisterna magna(ICM) and intrastriatal(IST) routes. Vector and trastuzumab blood/plasma concentrations were assessed at different time points up to the terminal time point of 21 days. Different brain regions in addition to the spinal cord, cerebrospinal fluid(CSF) and interstitial fluid(ISF), were also analyzed at the terminal time point. Our results show that vector biodistribution and Trastuzumab expression in the brain could the ranked as follows: IST>ICM>ICV>IV. Rapid clearance of vector was observed after administration via the ICM and ICV routes. The ICV route produced similar expression levels across different brain regions, while the ICM route had better expression in the hindbrain and spinal cord region. The IST route had higher expression in the forebrain region compared to the hindbrain region. A sharp decline in trastuzumab plasma concentration was observed across all routes of administration due to anti-trastuzumab antibody response. CONCLUSION: In this study we have characterized vector biodistribution and transgene mAb expression after AAV9 vector administration through different routes in rats. IST and ICM represent the best administration routes to deliver antibody genes to the brain.

Trends in long term growth outcome: comparison of two birth cohorts (year 2007-08 and year 2015-16).

Very low birth weight (VLBW) infants comprise between 4% and 8% of live-births and about one-third of deaths during the neonatal period. The objective of the study is to evaluate and compare the long-term growth outcomes of VLBW infants among two different birth cohorts: Cohort 2007-08 (cohort 1) and cohort 2015-16 (cohort 2), in a cross-sectional observational study. The neonatal and perinatal data of cohort 1 was collected from available trial data and the same data from cohort 2 was collected from patient case files and patient history. The primary outcome of the study was to compare the growth outcomes of VLBW infants attending the follow-up clinic between 12 and 18 months of corrected age from two different birth cohorts. Respectively, 238 and 268 infants were eligible for inclusion in cohort 1 and 2. Among the eligible infants, 148 infants in cohort 1 and 178 infants in cohort 2 were available for primary outcome assessment during the recruitment phase. The weight and length at corrected age (12 to 18 months) is significantly higher in cohort 2 compared to that in cohorts 1 although the mean age at assessment is similar between the two groups. There is a significant reduction in the incidence of underweight in infants that belonged to cohort 2. The proportions of infants who are underweight at follow-up were significantly lower in cohort 2 when compared to cohort 1, and there were no significant differences in the incidence of stunting and microcephaly among both the cohorts.

Metronidazole induced cutaneous adverse drug reaction- a systematic review of descriptive studies.

BACKGROUND: A substantial number of research studies on metronidazole-related cutaneous symptoms have recently been published. Our objective was to identify and evaluate descriptive studies that described metronidazole-related skin manifestations, therapeutic interventions, and consequences. METHODOLOGY: A comprehensive literature search was carried out in the PubMed, Scopus, and grey literature databases from inception to April 2022 without any constraints, as well as a snowball search in Google and a search in Google Scholar. Descriptive articles describing metronidazole-related cutaneous manifestations were considered for the review. Two distinct reviewers carried out the research selection, data extraction, and quality assessment; any discrepancies were resolved by consensus with the third reviewer. RESULTS: About 24 out of 4648 descriptive studies, including 26 patients (20 Female patients and 6 male patients), were included in this review. The included studies comprised a range of ages from 16 to 78 years old. Metronidazole was indicated for the treatment of bacterial vaginosis, trichomoniasis, sepsis, anti-infection therapy, perforated appendicitis, rosacea, vaginal discharge, dysentery, acne rosacea, trichomonal vaginitis, lichen planus, liver abscess, facial rosacea, intestinal amoebiasis, and gingivitis. Fixed drug eruption was the most common skin manifestation which was reported in 7 cases included in this review. Cutaneous manifestations were ameliorated by cessation of the offending drug and by apportioning antihistamines, topical steroids, parenteral corticosteroids, emollients, and topical moisturizers. CONCLUSION: Clinicians and healthcare professionals should be cognizant of the potential cutaneous adverse drug reactions (CADRs) induced by metronidazole to mitigate fatal circumstances. The management of the CADRs appears to respond effectively with immediate drug discontinuation and supportive therapy.

Quality of Life of Parents of Very Low Birth Weight Babies Admitted to the Neonatal Intensive Care Unit.

This prospective cohort study was conducted at our tertiary care center from October, 2021 to April, 2022 to compare the parents' health-related quality of life (HRQoL) scores during neonatal intensive care unit (NICU) stay and at 3 months follow-up. Pediatric quality of life inventory (PedsQL) family impact module questionnaires were used in 46 mothers and 39 fathers during NICU stay, and 42 mothers and 38 fathers at 3-month follow-up. Greater proportions of mothers were severely affected and had higher stress levels as compared to fathers both during NICU stay (67.3% vs 48.7%) and at 3 months follow-up (62.7% vs 52.6%). Among the mothers, there was a significant improvement in individual and family functioning median (IQR) HRQL scores at 3-month follow-up [62 (48-83) vs 71(63-79)]. However, the pro-portion of mothers severely affected remained the same at NICU stay and 3-month follow-up (67.3% vs 62.7%).

Enablers and barriers for enteral feeding with mother`s own milk in preterm very low birth weight infants in a tertiary care neonatal intensive care unit.

BACKGROUND: The management of lactation in preterm mothers is a real challenge for Neonatal Intensive Care Unit (NICU) care, providers. The study aimed to evaluate the enablers and barriers for enteral feeding with mothers` own milk (MOM) in preterm very low birth weight (VLBW) infants in a tertiary care neonatal unit. METHODS: This prospective observational study took place at a tertiary level NICU of a high-risk obstetric unit in a private hospital. All VLBW infants and mothers were incorporated into the study. Data on enablers and barriers were gathered from mother-baby dyads at the time of birth, at the end of the 7th day, and then weekly till the discharge of the baby from the unit. RESULTS: We studied 87 mother-baby dyads. Mean (SD) maternal age, gestation age and birth weight were 29.3 (4.7) years, 30.8 (2.0) weeks, and 1196 (196) grams respectively. We categorized our data into 2 groups based on outcome estimates done during the entire hospital stay or pre-discharge (48 hours before the discharge). On comparison of perinatal and post-natal factors, the enablers were maternal dwelling from the rural locality, number of milk expression son day 1 after the birth, number of night expressions in the first week postnatally, and MOM volume till day 3, day 7, and 2 weeks postnatally. The enablers of MOM in the pre-discharge group were the number of expressions in the first 3 days, the number of night expressions in week 1, mother`s visit, and the number of maternal visits on day 1 to NICU and MOM volume expressed from day 1 until the second week after birth. The main barriers for MOM (48 hours pre-discharge) were extremely low birth weight (ELBW) and intrauterine growth-restricted infants (IUGR). CONCLUSIONS: ELBW infants and IUGR infants are susceptible to low MOM feeding. The total of milk expressions in the first 3 days, number of night expressions in the first week, maternal visits on day 1 and the average MOM amount in the first 2 weeks are enablers for MOM feeding.

Plethysmography variability index (PVI) changes in preterm neonates with shock-an observational study.

Shock is an acute state of circulatory dysfunction. The diagnosis of shock is complex in neonates. The relative sensitivity of current clinical or laboratory findings for detecting shock is largely unknown, especially for preterm neonates. For preload assessment, inferior vena cava (IVC) collapsibility can be a useful bedside echocardiography parameter. plethysmography variability index (PVI) is a marker of fluid responsive shock in adults and children, but not well defined in neonates. In this prospective observational study, we evaluated the changes in PVI in preterm neonates with shock. Among the 37 infants enrolled in the study, the mean blood pressure (MAP) was 45 (± 4 mm of Hg) and none of infants had hypotension. The mean pulse pressure was 28 mm of Hg, the mean PVI was 28% (±5), the mean arterial blood gas pH was 7.20 (±0.07), and the mean base deficit was 9.9 (±2.53) at the onset of shock. Thirty (96.77%) of the 31 infants with resolution of shock showed decrease in PVI with an average decrease of 11% (±5).Conclusion: Significant proportion of neonates show an increase in PVI at the onset of shock. What is Known: • Plethysmography Variability Index (PVI) is commonly used as a marker of volume status in paediatric population. • Changes in PVI may guide in giving volume boluses in patients with shock. What is New: • This study provides information of changes in PVI in preterm neonates with shock. • PVI may become a valuable tool to be used at bedside in preterm infants with shock.

Echocardiographic assessment of hemodynamic changes in preterm neonates with shock: a prospective pragmatic cohort study.

Shock is a state of circulatory dysfunction and its diagnosis is complex in neonates. Hemodynamic assessment using echocardiography has potential to guide better management regimes in neonates with shock. Objective of this study is to analyze changes in the echocardiographic parameters in preterm neonates with shock at presentation and after resolution. In this prospective pragmatic Cohort study, eligible neonates with shock were monitored for changes in echocardiographic parameters at onset of shock and after resolution of shock. Paired data analysis was done for observed changes in the parameters. Based on initial clinical parameters and echocardiographic parameters, infants were assigned into different types of shock. Data of 37 infants were analyzed for baseline clinical and echocardiographic parameters, and data of 31 infants were analyzed for the changes in the observed parameters after shock resolution. Statistically significant changes were observed in inferior vena cava collapsibility index (ICI), left ventricular end diastolic volume (LVEDV), isovolemic ventricular relaxation time (IVRT), left and right ventricular stroke volume, and ejection fraction (EF). There was no agreement between clinical and echocardiographic definitions of shock.Conclusion: We noticed shock has overlapping pathophysiologic features. Our study highlights the importance of baseline documentation of echocardiographic parameters of all infants who are at risk of shock and repeat echocardiography at onset of shock to observe the changes in ICI, LVEDV, IVRT, stroke volume, and EF. This would guide pathophysiological management of shock in neonates. What is Known: • In neonates pathophysiology of shock is overlapping. • Echocardiography can help in better understanding and management of shock. What is New: • Study gives median changes in major echocardiographic parameters in neonatal shock. • These changes can guide for selection of volume and inotropes in management.

Quality improvement initiative to improve mother's own milk usage till hospital discharge in very low birth weight infants from a tertiary care NICU.

IMPORTANCE: Mother's own milk (MOM) for premature infants is a complete nutrition. It is an ideal issue for a quality improvement (QI) initiative. OBJECTIVE: To increase the proportionate usage of MOM as enteral feeds. METHODS: A QI study conducted in Tertiary care NICU involving all eligible very low birth weight (VLBW) infants and mother dyads. The proportionate usages of MOM as enteral feeds were the main outcomes. EXPOSURE: Education, milk expression, and mother-infant interaction formed the key drivers. RESULTS: We studied 282 mother infant dyads during the QI period. The proportionate usage of MOM as the enteral feed increased from 55% (±34) at baseline to 80% (±27) during the intervention and to 88% (±16) in sustenance phase. CONCLUSIONS: A QI initiative resulted in 60% relative improvement in proportionate usage of MOM as enteral feeds in VLBW infants during hospital stay.

Oral Paracetamol vs Oral Ibuprofen in Patent Ductus Arteriosus: A Randomized, Controlled, Noninferiority Trial.

OBJECTIVE: To test the hypothesis that oral paracetamol is non-inferior to oral ibuprofen in closing hemodynamically significant patent ductus arteriosus (hsPDA) with an a priori noninferiority (NI) margin of 15%. STUDY DESIGN: Multicenter, randomized, controlled, NI trial conducted in level III neonatal intensive care units. Consecutively inborn preterm neonates of <32 weeks of gestation with hsPDA were included. Those with structural heart disease, major malformations, and contraindications for enteral feeding or for administration of study drugs were excluded. Interventions included oral paracetamol in the experimental arm and oral ibuprofen in the active control arm. The primary outcome was closure of hsPDA by 24 hours from the last dose of the study drug. Secondary outcome measures included closure of hsPDA by 24 hours after the first course of the study drug, rate of reopening after the first course, and adverse events associated with the study drug. RESULTS: Out of 1250 neonates screened, 161 were randomized. Oral paracetamol was noninferior to oral ibuprofen in closure of hsPDA by both per protocol analysis (62 [95.4%] vs 63 [94%]; relative risk [RR], 1.01 [95% CI, 0.94-1.1]; risk difference [RD], 1.4 [95% CI, -6 to 9]; P = .37) and intention-to-treat analysis (63 [89%] vs 65 [89%]; RR, 0.99 [95% CI, 0.89-1.12]; RD, -0.3 [95% CI, -11 to 10]; P = .47). All adverse events were comparable in the 2 study arms. CONCLUSIONS: Oral paracetamol is noninferior to oral ibuprofen for the closure of hsPDA in preterm neonates of <32 weeks of gestation. No difference was observed in the adverse events studied.

Comparison of delivered distending pressures in the oropharynx in preterm infant on bubble CPAP and on three different nasal interfaces.

OBJECTIVE: To compare the level of continuous positive airway pressure (CPAP) delivered by three different CPAP delivery interfaces (RAM cannula system, Hudson prongs, and nasal mask) in preterm neonates with respiratory distress. METHODS: Preterm neonates with gestation between 28 weeks and 34 weeks and birth weight more than or equal to 1000 g and requiring nasal CPAP for respiratory distress were eligible for the study. During the study period, consecutive infants requiring CPAP were started on Hudson prongs or RAM cannula or nasal mask in that order. We measured the mean oropharyngeal pressure, which approximates the applied CPAP level. Oropharyngeal pressures in the recruited neonates were measured between 24 and 48 hours of postnatal age, when stable and in sleep or quiet awake state. Comparison of the delivered oropharyngeal pressures when on three different nasal interfaces at the same set flow rate and at set CPAP of 5 cm or 6 cm of H2 O was the primary outcome. RESULTS: Data was analyzed from 30 neonates in each group. We found that measured oropharyngeal pressures were less than set CPAP level in all three studied interfaces. Maximum drop in oropharyngeal pressure was observed with use of RAM cannula with measured oropharyngeal pressures being 1.1 and 1.2 cm H2 O less than set CPAP of 5 and 6 cm H2 O respectively. Pharyngeal pressure best correlated to set CPAP level with the use of nasal mask. CONCLUSION: None of the nasal interfaces delivered oropharyngeal pressure equivalent to the set CPAP. However, nasal mask delivered oropharyngeal pressure best matched to the set CPAP.

Growth and Neurodevelopmental Outcomes at 12 to 18 Months of Corrected Age in Preterm Infants Born Small for Gestational Age.

OBJECTIVE: To compare the growth and neurodevelopmental outcomes at 12 to 18 months of corrected age in preterm infants (gestation < 35 wks) born appropriate for gestation (AGA) with those born small for gestation (SGA). METHODOLOGY: This cross sectional, study assessed the growth outcomes in terms of underweight, stunting, microcephaly, overweight and obesity. Development delay was defined as developmental quotient < 70 on DASII. RESULTS: Out of 178 infants enrolled in the study 119 were AGA and 59 were SGA. The mean gestational age of the study cohort was 30.45 (2.08) weeks. More infants in the SGA group were underweight (59.3% vs. 37.8%, RR: 1.79, 95% CI: 1.16-2.74), stunted (62.7% vs. 30.25%, RR: 2.19, 95% CI: 1.42-3.36) and had higher incidence of motor (6.7% vs.0.8%, RR: 2.5, 95% CI: 1.5-4.1) and mental development (3% vs. 0, RR: 3.1, 95% CI: 2.5-3.8) delay. CONCLUSIONS: Preterm SGA infants are at an increased risk of underweight, stunting, motor and mental development delay when compared with preterm AGA infants in early childhood.

Effect of colostrum given within the 12 hours after birth on feeding outcome, morbidity and mortality in very low birth weight infants: a prospective cohort study.

The current study aims to compare the feeding outcome, morbidity and mortality in very low birth weight (VLBW) infants who received early colostrum (<12 hours of life) and those who did not. All VLBW infants admitted to neonatal intensive care unit (NICU) were eligible for the study. Eligible infants were enrolled after obtaining written informed consent from either of the parents. Newborns who received colostrum within the first 12 hours after birth formed the study cohort and all others the control cohort. Both cohorts were followed till discharge from NICU. During the study period, 205 VLBW infants were admitted in NICU of whom 171 (83%) infants were enrolled in the study. Both study groups were comparable for mean birth weight, mean gestation and male sex. The proportion of infants with abnormal Doppler was significantly higher in the control group. All outcomes were adjusted for antenatal Doppler abnormalities. The primary outcome of time to reach full feeds in the study population was 6.90 ± 4.4 days as compared to 9.80 ± 4.86 days in the control group with a significant weighted mean difference of -2.4 (-0.8 to -3.9) days. Duration of total parenteral nutrition (TPN) days and mortality were all lower in the study cohort. Risk of sepsis and necrotising enterocolitis was similar in the both groups. Enteral colostrum within first 12 hours of birth in VLBW infants reduces the time to reach full feeds, TPN days and mortality.

'Nasal mask' in comparison with 'nasal prongs' or 'rotation of nasal mask with nasal prongs' reduce the incidence of nasal injury in preterm neonates supported on nasal continuous positive airway pressure (nCPAP): A randomized controlled trial.

BACKGROUND: With increasing use of nCPAP, the safety and comfort associated with nCPAP have come into the forefront. The reported incidence of nasal injuries associated with the use of nCPAP is 20% to 60%. A recent meta-analysis concluded that the use of nasal masks significantly decreases CPAP failure and the incidence of moderate to severe nasal injury and stress the need for a well powered RCT to confirm their findings. METHODS: In this Open label, 3 arms, sequential, stratified randomized controlled trial, we evaluated the incidence and severity of nasal injury at removal of nCPAP when using two different nasal interfaces and in three groups (i.e. rotation group, mask continue group, prong continue group). Preterm infants with gestation ≤ 30 weeks and respiratory distress within the first 6 hours of birth and in need of CPAP were eligible for the study. RESULTS: Among the 175 newborns included in the study, incidence of nasal injury in mask continue group [n = 19/57 (33.3%)] was significantly less as compared to prong continue group [n = 55/60 (91.6%)] and rotation group [33/ 58 (56.9%), p value <0.0001]. Median maximum nasal injury score was significantly less in Mask continue group as compared to Prong continue group and Rotation group [Injury Score 0 (IQR 0-1) vs. Injury Score 3 (IQR 2-5) vs. Injury Score 1 (IQR 0-2), p value = <0.0001] respectively. The proportion of infants failing nCPAP was similar across the three groups. CONCLUSION: nCPAP with nasal masks significantly reduces nasal injury in comparison with nasal prongs or rotation of nasal prongs and nasal masks. However, the type of interface did not affect the nCPAP failure rates.

Suicidal thought and behavior in individuals with restless legs syndrome.

BACKGROUND: Restless legs syndrome (RLS) is associated with an unrelenting urge to move at night, which can cause chronic sleeplessness, depression, and despondency; thus increasing risk of suicide. We aimed to determine frequency of suicidal ideation and behavior in RLS. METHODS: RLS and control participants were recruited through community and RLS Foundation advertisements. RLS diagnosis was confirmed using the Cambridge-Hopkins RLS Questionnaire and severity was assessed using the International RLS Study Group Severity Scale (IRLSS). Lifetime suicidal ideation (plan) and behavior (attempt) was assessed using the Suicidal Behavior Questionnaire-revised. The Brief Lifetime Depression Scale evaluated lifetime depression history. Forward stepwise logistic regression determined the odds of suicidal ideation or behavior. RESULTS: In this study, 192 RLS and 158 control participants were comparable for age, sex, race, and other potential demographic confounders. In general, RLS was moderate-to-severe (mean IRLSS 26.4 ± 7.5). Significantly more RLS than control participants had lifetime suicidal ideation or behavior (27.1% vs. 7.0%; p < 0.00001) or lifetime depression history (65.6%% vs. 22.8%; p < 0.00001). The odds of having a lifetime suicidal ideation or behavior was higher in those with RLS [2.80 (1.29,6.11)], even after accounting for depression and other confounders. In RLS, the odds of lifetime suicidal ideation or behavior was increased if there was lifetime depression [7.37 (2.65,20.47)] or if RLS in the past was severe or very severe [2.36 (1.03,5.40)]. CONCLUSIONS: Lifetime suicidal ideation or behavior is prevalent in RLS sufferers, and its likelihood is dependent on RLS severity and depression history.

Quality Improvement Collaborative for Preterm Infants in Healthcare Facilities.

Across all healthcare settings, it is important not only to provide safe and effective healthcare, but also to ensure that it is timely, patient-centered, efficient and equitable. There is a wide variability in neonatal and perinatal outcomes in India and other developing countries, with certain units demonstrating clinical outcomes that match the developed world, while others showing higher than expected mortality and morbidity. Collaborative quality improvement initiatives offer a pragmatic way to improve performance of healthcare delivery within and between neonatal units. Variations in application of evidence-based healthcare process and dependent health outcomes can be identified and targeted for improvement in quality improvement cycles. We herein describe the concept of Collaborative quality improvement, and the success stories of the best-known Collaborative quality improvement initiatives across the world. We also highlight the process and progress of creating Collaborative quality improvement in our country.

Demoralization in Parkinson disease.

OBJECTIVE: To determine the prevalence and associated features of demoralization in Parkinson disease (PD). METHODS: Participants with PD and controls were prospectively recruited from outpatient movement disorder clinics and the community. Demoralization was defined as scoring positively on the Diagnostic Criteria for Psychosomatic Research, Demoralization questionnaire or Kissane Demoralization Scale score ≥24. Depression was defined as Patient Health Questionnaire-9 score ≥10. Forward stepwise logistic regression was used to determine the odds of having demoralization in the overall, control, and PD cohorts. RESULTS: Demoralization occurred in 18.1% of 94 participants with PD and 8.1% of 86 control participants (p = 0.05). These 2 groups were otherwise comparable in age, sex, education, economics, race, and marital status. Although demoralization was highly associated with depression, there were individuals with one and not the other. Among participants with PD, 7 of 19 (36.8%) depressed individuals were not demoralized, and 5 of 17 (29.4%) demoralized individuals were not depressed. In the overall cohort, having PD (odds ratio 2.60, 95% confidence interval 1.00-6.80, p = 0.051) was associated with demoralization, along with younger age and not currently being married. In the PD cohort, younger age and Unified Parkinson's Disease Rating Scale, part III score (per score 1) were associated with demoralization (odds ratio 1.06, 95% confidence interval 1.01-1.12, p = 0.02). CONCLUSIONS: Demoralization is common in PD and is associated with motor dysfunction. In demoralization, there is a prominent inability to cope, making it somewhat distinct from depression. Treatment approaches are also different, making it important to identify demoralization in patients with PD.

Effect of Nasal Continuous Positive Airway Pressure on Infants With Meconium Aspiration Syndrome: A Randomized Clinical Trial.

Importance: Nasal continuous positive airway pressure (NCPAP) as a primary respiratory therapy in meconium aspiration syndrome (MAS) has not been studied extensively. Nasal continuous positive airway pressure, when applied in newborns with MAS, may resolve atelectasis by sufficiently expanding partially obstructed small airways and stabilizing the collapsing terminal airways to enhance oxygen exchange. Objective: To compare NCPAP vs standard care in neonates with moderate to severe respiratory failure due to MAS in reducing the need for invasive ventilation. Design, Settings, and Participants: This multicenter open-label, parallel-group (1:1 ratio) randomized clinical trial was conducted from August 5, 2014, to May 26, 2016. Data were collected from 3 tertiary care neonatal intensive care units. All infants admitted with respiratory distress, defined as Downe score greater than 4 and peripheral capillary oxygen saturation less than 90%, were assessed for study eligibility if the chest radiograph was suggestive of MAS and they met the other inclusion criteria: gestation longer than 35 weeks, a birth weight greater than 2000 g, and born through meconium-stained amniotic fluid. Interventions: Infants were randomly assigned to either NCPAP or standard care (5-10 L/min hood oxygen). Main Outcomes and Measures: The primary outcome was the need for mechanical ventilation in the first 7 days of life. Results: After excluding 14 infants, 67 infants were randomized to bubble NCPAP and 68 infants to standard care. Baseline characteristics were similar between the 2 groups. Infants randomized to the bubble NCPAP group needed mechanical ventilation less frequently in the first 7 days of life compared with standard care (2 [3.0%] vs 17 [25.0%]); odds ratio, 0.09; 95% CI, 0.02-0.43; P = .002). The need for surfactant (3 [4.5%] vs 11 [16.2%]; odds ratio, 0.24; 95% CI, 0.05-0.87) and culture-positive sepsis (4 [6.0%] vs 13 [19.0%]; odds ratio, 0.28; 95% CI, 0.09-0.93) were higher in the standard care group. There was an increased duration of oxygen therapy (median [interquartile range], 45.5 [28.0-78.3] vs 26 [20.0-48.0] hours; P = .001) in the standard care group. In the NCPAP group vs standard care group, incidence of persistent pulmonary hypertension (9 [13%] vs 19 [28%]; odds ratio, 0.42; 95% CI, 0.17-1.01) and duration of hospital stay (median [interquartile range], 5.0 [4.0-8.8] vs 4.0 [4.0-6.0] days; P = .14) were similar. Conclusions and Relevance: Bubble NCPAP in comparison with standard care for infants with MAS reduces the need for mechanical ventilation in the first 7 days of life. Trial Registration: Clinical Trial Registry, India Identifier: CTRI/2015/03/005631.

Nasal continuous positive airway pressure therapy in a non-tertiary neonatal unit: reduced need for up-transfers.

OBJECTIVE: To evaluate the need for up-transfer after starting of nasal continuous positive airway pressure (n-CPAP) services in a Level II special newborn care unit (SNCU). METHODS: Five hundred fifty infants admitted to Level II SNCU, 252 infants during one year prior to introduction of n-CPAP (retrospective data from case records and electronic data base) and 298 infants during one year after introduction of n-CPAP services (prospective data in predefined case reporting form) were evaluated in this before and after intervention trial. The primary outcome was proportion of infants needing up-transfers from Level II SNCU for any indication. RESULTS: Baseline demographic data like birth weight, gestation and other perinatal factors were similar between the two epochs. Among the infants admitted to Level II SNCU, up-transfer for any reason was significantly higher in the pre-CPAP epoch compared with CPAP epoch (n = 93, 36 % vs. n = 74, 24.8 %, p = 0.002, OR 0.56, 95 % CI 0.38 to 0.83). However parent desired up-transfers were similar between the two epochs (n = 9, 3 % vs. n = 16, 5 %, p = 0.40). Introduction of n-CPAP treatment modality reduced up-transfers in subgroups of very low birth weight infants (VLBW) (n = 20, 74 % vs. n = 15, 37 %, p = 0.003) and also in preterm infants (n = 50, 54 % vs. n = 34, 32 %, p = 0.002). CONCLUSIONS: Introduction of n-CPAP services in a non-tertiary care neonatal unit, significantly reduced the need for up-transfers, especially in VLBW and preterm infants.