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  1. Palaian S, Ibrahim MI, Mishra P
    Pharm Pract (Granada), 2011 Oct;9(4):228-235.
    PMID: 24198861
    BACKGROUND: Ozzzzzzzair.

    OBJECTIVE: Ozzzzzzzair.

    METHODS: Ozzzzzzzair.

    RESULTS: Ozzzzzzzair.

    CONCLUSIONS: Ozzzzzzzair.

  2. Palaian S, Ibrahim MI, Mishra P
    Pharm Pract (Granada), 2010 Jul;8(3):201-7.
    PMID: 25126141
    The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists.
  3. Palaian S, Ibrahim MI, Mishra P
    Pharm Pract (Granada), 2010 Jul;8(3):179-86.
    PMID: 25126138
    Analyzing the pattern and quality of scientific communications on pharmacovigilance can help the regional centers in Nepal and other developing countries to develop approaches for communicating effectively medicine safety issues. This kind of research is lacking in developing countries.
  4. Palaian S, Poudel A, Alam K, Mohamed Ibrahim MI, Mishra P
    Int J Clin Pharm, 2011 Aug;33(4):591-6.
    PMID: 21562802 DOI: 10.1007/s11096-011-9512-3
    Nepal experiences several medicine-use problems like any other developing country. In the recent years, there have been initiatives to introduce the concept of social pharmacy in Nepal, and there has been only a limited research in this area. The staff members at the Manipal College of Medical Sciences, Pokhara have shown keen interest in initiating several social pharmacy-related researches in the country. The members of this institute have been collaborating with two international universities, namely Universiti Sains Malaysia located in Malaysia and Chulalongkorn University located in Thailand, to get academic and technical supports. In this manuscript, the authors share their experiences in initiating social pharmacy research in the country. Authors have also mentioned the priority areas of social pharmacy research in Nepal and the importance of initiating this concept in the country.
  5. Upadhyay DK, Mohamed Ibrahim MI, Mishra P, Alurkar VM
    BMC Health Serv Res, 2015;15:57.
    PMID: 25888828 DOI: 10.1186/s12913-015-0715-5
    Patient satisfaction is the ultimate goal of healthcare system which can be achieved from good patient-healthcare professional relationship and quality of healthcare services provided. Study was conducted to determine the baseline satisfaction level of newly diagnosed diabetics and to explore the impact of pharmaceutical care intervention on patients' satisfaction during their follow-ups in a tertiary care teaching hospital in Nepal.
  6. Upadhyay DK, Mohamed Ibrahim MI, Mishra P, Alurkar VM
    J Pharm Bioallied Sci, 2020 07 18;12(3):234-245.
    PMID: 33100782 DOI: 10.4103/jpbs.JPBS_6_20
    Introduction: Diabetics face a series of challenges that affect all aspects of their daily life. Diabetes related complications adversely affect patient's health-related quality of life (HRQoL). Knowledge and self-care skills of diabetics are corner stones to improve their HRQoL.

    Objective: To assess the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics using an Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire.

    Materials and Methods: A pre-post comparison study was conducted among the control group (CG), test 1 group (T1G) and test 2 group (T2G) patients with three treatment arms to explore the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics for 18 months. Patients' HRQoL scores were determined using ADDQoL questionnaire at baseline, 3, 6, 9 and 12-months. T1G patients received pharmacist's intervention whereas T2G patients received diabetic kit demonstration in addition to pharmacist's intervention. CG patients were deprived of pharmacist intervention and diabetic kit demonstration, and only received care from attending physician/nurses. Non-parametric tests were used to find the differences in an average weighted impact scores (AWIS) among the groups before and after the intervention at P ≤ 0.05.

    Results: Friedman test identified significant (P < 0.001) improvement in AWIS among the test groups' patients. Differences in scores were significant between T1G and T2G at 6-months (P = 0.033), 9-months (P < 0.001) and 12-months (P < 0.001); between CG and T1G at 12-months (P < 0.001) and between CG and T2G at 9-months (P < 0.001) and 12-months (P < 0.0010) on Mann.Whitney U test.

    Conclusion: Pharmacist's intervention improved AWIS of test groups' diabetics. Diabetic kit demonstration strengthened the disease understanding and selfcare skills of T2G patients. Disease and self-care awareness among diabetics should be increased in Nepali healthcare system by involving pharmacists for better patient's related outcomes.

  7. Zaid RM, Mishra P, Wahid ZA, Sakinah AMM
    Int J Biol Macromol, 2019 Aug 01;134:361-367.
    PMID: 31059740 DOI: 10.1016/j.ijbiomac.2019.03.143
    In the present study, high-methoxyl pectin (HMP) was extracted from Hylocereus polyrhizus peel's using physico-chemical process. In addition, the hypolipidemic activity of HMP was investigated at different concentration and time corresponding to its adsorption ability. FTIR and contact angle analysis were used to determine the sorbent characterization. A high degree of esterification (63.8%) and the contact angle (95.5°) confirmed hydrophobic nature and resulting bad wetting of the HMP extract, respectively. The methoxyl content in the pectin acted as an affinity-precursor of the pectin towards cholesterol due to its increased hydrophobicity. The maximum equilibrium uptake capacity of cholesterol of 370.5mg/g (0.96mmol/g) was observed by HMP. The experimental data showed good fitting for Freundlich isotherm equation and followed pseudo-first-order kinetic model with a correlation coefficient (R2) of 0.89-0.97 due to physisorption mechanism. Intra-particle model confirmed that the cholesterol sorption rate by HMP was significantly influenced by external mass transfer (surface diffusion) and intra-particle diffusion (diffusion control). It was also revealed that the HMP extracted from Hylocereus polyrhizus peels possess a high affinity towards cholesterol, making it an ideal hypolipidemic agent.
  8. Palaian S, Ibrahim MIM, Mishra P, Shankar PR
    J Pharm Bioallied Sci, 2021 05 26;13(2):248-255.
    PMID: 34349487 DOI: 10.4103/jpbs.JPBS_528_20
    Background: The aim of the study was to assess the impact of a pharmacovigilance module on the knowledge, attitude, and practice (KAP) of pharmacy students and elucidate their feedback on the module.

    Methodology: Bachelor of pharmacy students at Pokhara University, Nepal, were assessed for their baseline KAP on drug safety and related issues using a KAP questionnaire (Cronbach alpha 0.70) consisting of 25 questions. Students' baseline KAP was assessed and after that, they were grouped into either control (2nd and 4th year) or test (1st and 3rd year) groups. The later received the pharmacovigilance training in three 1-h sessions spread over 6 months at 0, 90, and 180 days; the sessions covered introduction to pharmacovigilance, theoretical aspects of pharmacovigilance, and adverse drug reaction reporting procedures. KAP scores and student feedback were analyzed at 5% significance level.

    Results: A total of 124 students (control = 56 and test = 68) were studied. The median (interquartile ranges [IQRs]) of the baseline scores prior to grouping the students into control and test groups was 20 (18.25-21.00) for knowledge, 19.5 (18.00-21.00) for attitude/practice, and 39 (37.00-41.00) for the total score. Males (n = 81) had a slightly higher median score of 40 (37-42) than females (n = 43), who had a median score of 38 (36-41). The KAP score for the control group was 40 (38-42) at baseline, 42 (20-44) during first follow-up, 41.5 (40-44) during second follow-up, and 41 (39-44.5) during third follow-up. For the test group, upon intervention, the KAP scores improved from 39 (36.25-40.75) at baseline to 42 (39.50-44.00) at the 1st follow-up, 43 (41-45) at the 2nd follow-up, and 44 (42-45) at the 3rd follow-up (P < 0.001). The median feedback score (IQR) was 86 (81.5-90.0).

    Conclusions: Pharmacy students had good attitude/practice scores and relatively poor knowledge scores at baseline, which improved postintervention. Student feedback about the module was positive.

  9. Gupta H, Batta NS, Kataria H, Batra V, Upadhyay AD, Jain V, et al.
    Malays Orthop J, 2020 Mar;14(1):34-41.
    PMID: 32296480 DOI: 10.5704/MOJ.2003.006
    Introduction: An increased tibial tuberosity-trochlear groove (TTTG) distance is used for deciding a treatment plan in patello-femoral instability (PFI). The centre of the patellar tendon and the chondral trochlear groove can be directly visualised on MRI, and measured, giving the patellar tendon-trochlear groove (PTTG) distance. A study was designed to compare the inter-rater and the test-retest reliabilities of PTTG and TTTG measurements in MRI of patients without PFI and in a group with PFI.

    Materials and Methods: This cross-sectional reliability study was done on archival MRI films of 50 patients without patellar instability and 20 patients with patellar instability. TTTG and PTTG distances were independently measured by two orthopaedic surgeons and two radiologists. A hybrid PTTG measurement with bony landmarks on the femoral side and the patellar tendon landmark on the tibial side, was used to estimate the influence of the differences in the femoral and tibial landmarks on the difference in reliabilities. The intra-class correlation coefficient (ICC) was calculated for all four raters, as well as separately for each rater.

    Results: The PTTG distance had a higher inter-rater reliability (ICC=0.86, 95% CI=0.79-0.92) compared to the TTTG distance (ICC=0.70, 95% CI=0.59-0.80) in patients without PFI. Similar trends were seen in patients with PFI (0.83 vs 0.66). The inter-rater reliability for the hybrid PTTG distance was found to lie in between the TTTG and PTTG.

    Conclusions: The MRI-based PTTG distance had better inter-rater reliability compared with the MRI-based TTTG distance.

  10. Zaid RM, Mishra P, Tabassum S, Wahid ZA, Sakinah AMM
    Int J Biol Macromol, 2019 Dec 01;141:1147-1157.
    PMID: 31494156 DOI: 10.1016/j.ijbiomac.2019.09.017
    The effect of physicochemical treatment on pectin yield, degree of esterification, along with the kinetics and thermodynamics characteristics was investigated in the present study. Several extraction parameters were observed to have impacted the yield and degree of esterification significantly, and the best extraction condition was as follows: agitation rate of 250 rpm, temperature of 70 °C, extraction time of 120 min, pH 2, and liquid to solid ratio of 10 v/w which has resulted in 28.20% of pectin yield, with DE (degree of esterification) of 57.00%. A theoretical model which describes the extractability, dissolution and degradation rate of pectin to predict the maximal yield at the maximal time was established to study the extraction kinetics of pectin from HPP. The kinetic analysis from Panchev's model shows the extraction rate was found highest at LSR 10 with ymax 30.85%. The calculated activation energy for pectin dissolution and degradation was found to be 4.532 kJ/mol and 28.054 kJ/mol, respectively. The thermodynamic study has suggested that the process was endothermic, spontaneous and reversible. These results suggest that the physical and chemical treatment applied could be an efficient technique for the extraction of pectin from Hylocereus polyrhizus peels.
  11. Islam MA, Karim A, Mishra P, Dubowski JJ, Yousuf A, Sarmin S, et al.
    Sci Total Environ, 2020 Oct 10;738:140138.
    PMID: 32806344 DOI: 10.1016/j.scitotenv.2020.140138
    An understanding of the inter-species relationships, especially their metabolic network in a mixed-culture system, is crucial to design an effective inoculum for enhancing the power generation of wastewater fed microbial fuel cell (MFC). In the present study, the influence of microbial mutualistic interactions on the power generation of palm oil mill effluent fed MFCs has been widely investigated by designing several co-culture and mixed culture inoculums. Among the different inoculum compositions, the highest power density of 14.8 W/m3 was achieved by Pseudomonas aeruginosa and Klebsiella variicola co-culture inoculum due to their synergistic relationships which were inter-linked via fermentation-based metabolites. Besides, the interaction of K. variicola and Bacillus cereus positively influenced the power generation resulting in a maximum power density of 11.8 W/m3 whereas the antagonistic relationship between B. cereus and P. aeruginosa resulted in a lower power generation of 1.9 W/m3. The microbial mutualistic interactions were investigated with polarization, cyclic voltammetry (CV), electrochemical impedance spectroscopy (EIS), as well as by using metabolite and biofilm analysis. It was observed that the synergism between bacteria enhanced power generation through the production of higher electron shuttling mediators and efficient biofilm formation as evidenced by polarization, CV and EIS analysis. In contrast, the antagonistic relationship resulted in production of cell inhibiting metabolites leading to the formation of ineffective biofilm. These findings demonstrate that the synergistic interaction between or within microorganisms is emergent in designing co-culture or mixed-culture inoculum for achieving maximum power generation in MFCs.
  12. Rana S, Mishra P, Wahid ZA, Thakur S, Pant D, Singh L
    J Environ Sci (China), 2020 Mar;89:47-64.
    PMID: 31892401 DOI: 10.1016/j.jes.2019.09.023
    In an era of electronics, recovering the precious metal such as gold from ever increasing piles of electronic-wastes and metal-ion infested soil has become one of the prime concerns for researchers worldwide. Biological mining is an attractive, economical and non-hazardous to recover gold from the low-grade auriferous ore containing waste or soil. This review represents the recent major biological gold retrieval methods used to bio-mine gold. The biomining methods discussed in this review include, bioleaching, bio-oxidation, bio-precipitation, bio-flotation, bio-flocculation, bio-sorption, bio-reduction, bio-electrometallurgical technologies and bioaccumulation. The mechanism of gold biorecovery by microbes is explained in detail to explore its intracellular mechanistic, which help it withstand high concentrations of gold without causing any fatal consequences. Major challenges and future opportunities associated with each method and how they will dictate the fate of gold bio-metallurgy from metal wastes or metal infested soil bioremediation in the coming future are also discussed. With the help of concurrent advancements in high-throughput technologies, the gold bio-exploratory methods will speed up our ways to ensure maximum gold retrieval out of such low-grade ores containing sources, while keeping the gold mining clean and more sustainable.
  13. Upadhyay DK, Ibrahim MI, Mishra P, Alurkar VM, Ansari M
    Daru, 2016 Feb 29;24:6.
    PMID: 26926657 DOI: 10.1186/s40199-016-0145-x
    BACKGROUND: Cost is a vital component for people with chronic diseases as treatment is expected to be long or even lifelong in some diseases. Pharmacist contributions in decreasing the healthcare cost burden of chronic patients are not well described due to lack of sufficient evidences worldwide. In developing countries like Nepal, the estimation of direct healthcare cost burden among newly diagnosed diabetics is still a challenge for healthcare professionals, and pharmacist role in patient care is still theoretical and practically non-existent. This study reports the impact of pharmacist-supervised intervention through pharmaceutical care program on direct healthcare costs burden of newly diagnosed diabetics in Nepal through a non-clinical randomised controlled trial approach.
    METHODS: An interventional, pre-post non-clinical randomised controlled study was conducted among randomly distributed 162 [control (n = 54), test 1 (n = 54) and test 2 (n = 54) groups] newly diagnosed diabetics by a consecutive sampling method for 18 months. Direct healthcare costs (direct medical and non-medical costs) from patients perspective was estimated by 'bottom up' approach to identify their out-of-pocket expenses (1USD = NPR 73.38) before and after intervention at the baseline, 3, 6, 9 and 12 months follow-ups. Test groups' patients were nourished with pharmaceutical care intervention while control group patients only received care from physician/nurses. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences in direct healthcare costs among the groups before and after the intervention (p ≤ 0.05).
    RESULTS: Friedman test identified significant differences in direct healthcare cost of test 1 (p p p = 0.009, p = 0.010 respectively), 9-months (p = 0.005, p = 0.001 respectively) and 12-months (p p 
  14. Saha M, Togo A, Mizukawa K, Murakami M, Takada H, Zakaria MP, et al.
    Mar Pollut Bull, 2009 Feb;58(2):189-200.
    PMID: 19117577 DOI: 10.1016/j.marpolbul.2008.04.049
    We collected surface sediment samples from 174 locations in India, Indonesia, Malaysia, Thailand, Vietnam, Cambodia, Laos, and the Philippines and analyzed them for polycyclic aromatic hydrocarbons (PAHs) and hopanes. PAHs were widely distributed in the sediments, with comparatively higher concentrations in urban areas (Sigma PAHs: approximately 1000 to approximately 100,000 ng/g-dry) than in rural areas ( approximately 10 to approximately 100g-dry), indicating large sources of PAHs in urban areas. To distinguish petrogenic and pyrogenic sources of PAHs, we calculated the ratios of alkyl PAHs to parent PAHs: methylphenanthrenes to phenanthrene (MP/P), methylpyrenes+methylfluoranthenes to pyrene+fluoranthene (MPy/Py), and methylchrysenes+methylbenz[a]anthracenes to chrysene+benz[a]anthracene (MC/C). Analysis of source materials (crude oil, automobile exhaust, and coal and wood combustion products) gave thresholds of MP/P=0.4, MPy/Py=0.5, and MC/C=1.0 for exclusive combustion origin. All the combustion product samples had the ratios of alkyl PAHs to parent PAHs below these threshold values. Contributions of petrogenic and pyrogenic sources to the sedimentary PAHs were uneven among the homologs: the phenanthrene series had a greater petrogenic contribution, whereas the chrysene series had a greater pyrogenic contribution. All the Indian sediments showed a strong pyrogenic signature with MP/P approximately 0.5, MPy/Py approximately 0.1, and MC/C approximately 0.2, together with depletion of hopanes indicating intensive inputs of combustion products of coal and/or wood, probably due to the heavy dependence on these fuels as sources of energy. In contrast, sedimentary PAHs from all other tropical Asian cities were abundant in alkylated PAHs with MP/P approximately 1-4, MPy/Py approximately 0.3-1, and MC/C approximately 0.2-1.0, suggesting a ubiquitous input of petrogenic PAHs. Petrogenic contributions to PAH homologs varied among the countries: largest in Malaysia whereas inferior in Laos. The higher abundance of alkylated PAHs together with constant hopane profiles suggests widespread inputs of automobile-derived petrogenic PAHs to Asian waters.
  15. Garg A, Keng WT, Chen Z, Sathe AA, Xing C, Kailasam PD, et al.
    J Clin Invest, 2022 Dec 01;132(23).
    PMID: 36282599 DOI: 10.1172/JCI156864
    Multiple genetic loci have been reported for progeroid syndromes. However, the molecular defects in some extremely rare forms of progeria have yet to be elucidated. Here, we report a 21-year-old man of Chinese ancestry who has an autosomal recessive form of progeria, characterized by severe dwarfism, mandibular hypoplasia, hyperopia, and partial lipodystrophy. Analyses of exome sequencing data from the entire family revealed only 1 rare homozygous missense variant (c.86C>T; p.Pro29Leu) in TOMM7 in the proband, while the parents and 2 unaffected siblings were heterozygous for the variant. TOMM7, a nuclear gene, encodes a translocase in the outer mitochondrial membrane. The TOMM complex makes up the outer membrane pore, which is responsible for importing many preproteins into the mitochondria. A proteomic comparison of mitochondria from control and proband-derived cultured fibroblasts revealed an increase in abundance of several proteins involved in oxidative phosphorylation, as well as a reduction in abundance of proteins involved in phospholipid metabolism. We also observed elevated basal and maximal oxygen consumption rates in the fibroblasts from the proband as compared with control fibroblasts. We concluded that altered mitochondrial protein import due to biallelic loss-of-function TOMM7 can cause severe growth retardation and progeroid features.
  16. Khan PA, Mohammad A, Bansal SL, Lal B, Singh P, Singh R, et al.
    Mol Biotechnol, 2024 Jan 09.
    PMID: 38195817 DOI: 10.1007/s12033-023-01022-4
    Solid waste generation is a huge contributor to environmental pollution issues, and food wastes are prominent in this category due to their large generation on a day-to-day basis. Thus, the settlement of daily food waste is one of the major constraints and needs innovative manufacturing sheme to valorize solid waste in sustainable manner. Moreover, these food wastes are rich in organic content, which has promising scope for their value-added products. In the present study, raw mango seed waste has been biotransformed to produce bacterial hydrolytic enzymes as feedstock. On investigating the impact of substrate, the highest bacterial cellulase production was recorded to be 18 IU/gds FP (filter paper) in 24 h of microbial incubation at 5 g of substrate in solid-state fermentation (SSF). Furthermore, at 40 °C and pH 6.0, 23 IU/gds FP enzyme could be produced in 24 h of SSF. Beside this, on comparing the influence of inorganic and organic nitrogen sources, urea has been found to provide better cellulase production, which yielded 28 IU/gds FP in 24 h of incubation, along with 77 IU/gds BG (β-glucosidase) and 89 IU/gds EG (endoglucanase). On the other hand, Tween-40 and Tween-80, two different surfactants, were employed at a 1.0% concentration for 24 h of incubation. It was noticed that Tween-80 showed complete enzyme activity at 24 h, which was found to be relatively superior to that of Tween-40. This study may have potential utility in enzyme production using mango seed as a food waste for various industrial applications.
  17. Sharma A, Sharma C, Sharma L, Wal P, Mishra P, Sachdeva N, et al.
    PMID: 38334084 DOI: 10.1139/cjpp-2023-0259
    Mostly, cardiovascular diseases are blamed for casualties in rheumatoid arthritis (RA) patients. Customarily, dyslipidemia is probably the most prevalent underlying cause of untimely demise in people suffering from RA as it hastens the expansion of atherosclerosis. The engagement of inflammatory cytokines like tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), etc., is crucial in the progression and proliferation of both RA and abnormal lipid parameters. Thus, lipid abnormalities should be monitored frequently in patients with both primary and advanced RA stages. An advanced lipid profile examination, i.e., direct role of apolipoproteins associated with various lipid molecules is a more dependable approach for better understanding of the disease and selecting suitable therapeutic targets. Therefore, studying their apolipoproteins is more relevant than assessing RA patients' altered lipid profile levels. Among the various apolipoprotein classes, Apo A1 and Apo B are primarily being focused. In addition, it also addresses how calculating Apo B:Apo A1 ratio can aid in analyzing the disease's risk. The marketed therapies available to control lipid abnormalities are associated with many other risk factors. Hence, directly targeting Apo A1 and Apo B would provide a better and safer option.
  18. Oei JL, Saugstad OD, Lui K, Wright IM, Smyth JP, Craven P, et al.
    Pediatrics, 2017 01;139(1).
    PMID: 28034908 DOI: 10.1542/peds.2016-1452
    BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation.

    METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.

    RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13).

    CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.

  19. Thamrin V, Saugstad OD, Tarnow-Mordi W, Wang YA, Lui K, Wright IM, et al.
    J Pediatr, 2018 10;201:55-61.e1.
    PMID: 30251639 DOI: 10.1016/j.jpeds.2018.05.053
    OBJECTIVE: To determine rates of death or neurodevelopmental impairment (NDI) at 2 years corrected age (primary outcome) in children <32 weeks' gestation randomized to initial resuscitation with a fraction of inspired oxygen (FiO2) value of 0.21 or 1.0.

    STUDY DESIGN: Blinded assessments were conducted at 2-3 years corrected age with the Bayley Scales of Infant and Toddler Development, Third Edition or the Ages and Stages Questionnaire by intention to treat.

    RESULTS: Of the 290 children enrolled, 40 could not be contacted and 10 failed to attend appointments. Among the 240 children for whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died. The primary outcome, which was available in 238 (82%) of those randomized, occurred in 47 of the 117 (40%) children assigned to initial FiO2 0.21 and in 38 of the 121 (31%) assigned to initial FiO2 1.0 (OR, 1.47; 95% CI, 0.86-2.5; P = .16). No difference in NDI was found in 215 survivors randomized to FiO2 0.21 vs 1.0 (OR, 1.26; 95% CI, 0.70-2.28; P = .11). In post hoc exploratory analyses in the whole cohort, children with a 5-minute blood oxygen saturation (SpO2) <80% were more likely to die or to have NDI (OR, 1.85; 95% CI, 1.07-3.2; P = .03).

    CONCLUSIONS: Initial resuscitation of infants <32 weeks' gestation with initial FiO2 0.21 had no significant effect on death or NDI compared with initial FiO2 1.0. Further evaluation of optimum initial FiO2, including SpO2 targeting, in a large randomized controlled trial is needed.

    TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Network Registry ACTRN 12610001059055 and the National Malaysian Research Registry NMRR-07-685-957.

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