Development and Safety Trial of the OstreaVent2™ Prototype for Mechanically Ventilated Adult Patients.

Background: With the surge of COVID-19 infections, there were concerns about shortage of mechanical ventilator in several countries including the Philippines. Objective: To transform a locally made, low-cost, neonatal ventilator into a volume- and pressure-controlled, adult ventilator and to determine its safe use among ventilated, adult patients at the Philippine General Hospital. Methods: The modification of the neonatal ventilator (OstreaVent1) to the adult OstreaVent2 was based on the critical need for adult ventilators, in volume or pressure mode, in the Philippines due to the COVID-19 pandemic. The adult ventilator settings were calibrated and tested for two days to check for consistency and tolerance and then submitted to a third party for certification. Once certified, a safety trial of 10 stable adult patients on mechanical ventilator was conducted. The patients were placed on the OstreaVent2 for four hours while ventilator parameters, patient's vital signs, and arterial blood gases were monitored at baseline, during, and after placement on the OstreaVent2. A post-study chest radiograph was also done to rule out pulmonary complications, particularly atelectasis and pneumothorax. Results: The prototype OstreaVent2 received an FDA Certification for Medical Listing after passing its third-party certification. Ten patients (60% male) recruited in the study had a mean age of 39.1 ± 11.6 years. Half of the patients had a diagnosis of non-COVID-19 pneumonia. During the 4-hour study period, the patients while on the OstreaVent2, had stable ventilator settings and most of the variabilities were within the acceptable tolerances. Vital signs were stable and arterial blood gases were within normal limits. One patient developed alar flaring which was relieved by endotracheal tube suctioning. No patient was withdrawn from the study. One patient who was already transferred out of the ICU subsequently deteriorated and died three days after transfer to the stepdown unit from a non-ventilator related cause. Conclusion: The new OstreaVent2 is safe to use among adults who need ventilator support. Variabilities in the ventilator's performance were within acceptable tolerances. Clinical and blood gas measurements of the patients were stable while on the ventilator.

Factors associated with having COVID-19 among unvaccinated pregnant and non-pregnant women in Metro Manila, Philippines: a multicentre longitudinal cohort study.

OBJECTIVE: To determine the potential risk factors associated with having COVID-19 among unvaccinated pregnant and non-pregnant women. DESIGN: A multicentre prospective cohort study among eligible women in Metro Manila, Philippines, from 2020 to 2022. SETTING: Five national and local hospital research sites altogether recruited and screened 500 consenting eligible individuals. PARTICIPANTS: Pregnant and non-pregnant participants meeting the eligibility criteria were admitted for a reverse-transcription PCR determination of SARS-CoV-2, pregnancy testing and ultrasound, and an interview with an administered questionnaire. EXPOSURES: Primary exposure was pregnancy; secondary exposures involve sociodemographic, lifestyle and obstetric-gynaecologic factors. OUTCOME MEASURE: Outcome being measured was COVID-19 status. RESULTS: The significant COVID-19 risk factors were: pregnancy (PR=1.184, 95% CI 1.096, 1.279), having a white-collar job (PR=1.123, 95% CI 1.02, 1.235), travelling abroad (PR=1.369, 95% CI 1.083, 1.173) and being infected by at least one vaccine-preventable disease (VPD) (PR=1.208, 95% CI 1.113, 1.310). Protective factors included having graduate-level education (PR=0.787, 95% CI 0.649, 0.954), immunisation against a VPD (PR=0.795, 95% CI 0.733, 0.862) and practising contraception (PR=0.889, 95% CI 0.824, 0.960). CONCLUSION: This study is the first in the country to determine the risks influencing COVID-19 infection among unvaccinated pregnant and non-pregnant women. Pregnancy is a significant risk for COVID-19 among women in Metro Manila. Educational attainment and positive health behaviours seem to confer protection. Occupations and activities that increase the frequency of interactions, as well as history of communicable diseases may predispose women to COVID-19. Further studies are needed to elucidate the development of the disease in pregnant women, including the maternal and neonatal effects of COVID-19 via potential vertical mechanisms of transmission.

Applicability of the hour of life approach in hyperbilirubinemia among Filipino term infants.

Background: Hyperbilirubinemia remains a common morbidity among infants. Additional research on bilirubin kinetics and associated risk factors will contribute to providing a more targeted management approach for the Filipino infant. Objective: To develop a Filipino bilirubin nomogram by studying bilirubin patterns during the first 5 days of life. Methodology: This prospective study recruited 1,412 stable, full-term infants (≥37 weeks age of gestation) born at the Philippine General Hospital (PGH). Using the Dräger-Minolta JM-103 jaundice meter, transcutaneous bilirubin (TcB) levels were determined at the 3rd, 6th, 12th, 24th, 36th, 48th, 72nd, 96th, and 120th hour of life (HOL). A bilirubin nomogram was created using the averages of 3 TcB forehead and sternal measurements at each time epoch. Simultaneous measurement of TcB and total serum bilirubin (TsB) on a subset of 106 infants was done to determine correlation. Results: Correlation coefficients were high between TsB and forehead TcB (r2 = 0.88), and between TsB and sternal TcB (r2 = 0.91). The Filipino bilirubin nomogram reflected a steep rise until the 48th hour, followed by plateauing of values. Inadequate nursing and bilirubin levels at 12th and 48th HOL were risk factors for developing significant hyperbilirubinemia at 72nd HOL. Conclusion: TcB is a reliable, non-invasive bilirubin screening tool. Among healthy, full-term, Filipino infants, their nomogram features a sudden increase in bilirubin values during the first 48 h, followed by a plateau. To aid in identification of infants at risk for significant hyperbilirubinemia, healthcare providers can assess breastfeeding adequacy and perform bilirubin screening at the 24th-48th HOL. Registration No. (RGAO-2016-0686).

Risk factors of COVID-19 vertical transmission among pregnant and non-pregnant Filipinos in Metro Manila: a multicentre cohort study protocol.

INTRODUCTION: The novel (COVID-19 was first reported to have originated in Wuhan, China, in December 2019. This new strain, SARS-CoV-2, has spread rapidly worldwide, prompting the WHO to declare the COVID-19 outbreak a global pandemic. The main objective of this cohort study is to determine the risk factors of COVID-19, the modes of COVID-19 vertical transmission, and the maternal and fetal outcomes among non-pregnant and pregnant women and their fetuses. METHODS AND ANALYSIS: This is a multicentre epidemiological study that will involve a prospective cohort. COVID-19 status among consulting non-pregnant and pregnant women in public hospitals in Manila, Philippines, will be determined and monitored for 6-12 months. Swab specimens from the nasopharynx, cervix, rectum, amniotic fluid, placenta, cord blood and breastmilk will be collected during consult and admission for reverse transcription-PCR (RT-PCR) testing. Blood will be collected during the postdelivery period to monitor the women and their neonates for any undue development and determine the antibody development to indicate an infective or non-infective state. Evidence of vertical transmission will be explored with the presence or absence of the virus using the maternal and fetal neonatal RT-PCR and lateral flow antibody status. Descriptive and inferential statistics will be done, including the associations between exposures and risk factors, description of clinical characteristics, and the COVID-19 status of the participants. ETHICS AND DISSEMINATION: The Single Joint Research Ethics Board of the Department of Health has approved this protocol (SJREB 2020-30). The study results will be disseminated through conference presentations, peer-reviewed articles, and various stakeholder public forums and activities.

Cost-effectiveness of rotavirus vaccination in the Philippines: A modeling study.

INTRODUCTION: Rotavirus gastroenteritis (RVGE) remains a leading cause of hospitalization and death in children under five years of age in the Philippines. Rotavirus (RV) vaccination was introduced into the national immunization program (NIP) in 2012 but has since been limited to one region due to cost considerations and conflicting local cost-effectiveness estimates. Updated estimates of the cost-effectiveness of RV vaccination are required to inform prioritization of national immunization activities. METHODS: We calculated the potential costs and benefits of rotavirus vaccination over a 10-year-period (2021-2031) from a government and societal perspective, comparing four alternative rotavirus vaccines: Rotavac, Rotasiil, Rotarix and Rotateq. For each vaccine, a proportionate outcomes model was used to calculate the expected number of disease events, DALYs, vaccination program costs, and healthcare costs, with and without vaccination. The primary outcome measure was the cost per DALY averted. Assuming each product would generate similar benefits, the dominant (lowest cost) product was identified. We then calculated the cost-effectiveness (US$ per Disability Adjusted Life Year [DALY] averted) of the least costly product and compared it to willingness-to-pay thresholds of 0.5 and 1 times the national GDP per capita ($3,485), and ran deterministic and probabilistic sensitivity analyses. RESULTS: Introducing any of the four rotavirus vaccines would avert around 40% of RVGE visits, hospitalizations, and deaths over the period 2021-2031. Over the same ten-year period, the incremental cost of vaccination from a government perspective was estimated to be around $104, $105, $220, and $277 million for Rotavac, Rotasiil, Rotarix and Rotateq, respectively. The equivalent cost from a societal perspective was $58, $60, $178 and $231 million. The cost-effectiveness of the least costly product (Rotavac) was $1,148 ($830-$1682) from a government perspective and $646 ($233-1277) from a societal perspective. All other products offered similar benefits but at a higher cost. There is a >99% probability that Rotavac would be cost-effective at a willingness-to-pay threshold set at 0.5 times the national GDP per capita. CONCLUSION: Both Rotavac and Rotasiil are likely to be cost-effective options in the Philippines, but it is not possible to say definitively which product should be preferred. Rotarix and Rotateq are expected to offer similar benefits at more cost, so would need to be priced far more competitively to be considered for introduction.

Resuscitation of preterm infants in the Philippines: a national survey of resources and practice.

OBJECTIVE: There is a high incidence of preterm birth in low-income and middle-income countries where healthcare resources are often limited and may influence decision making. We aimed to explore the interplay between resource limitations and resuscitation practices for extremely preterm infants (EPIs) in neonatal intensive care units (NICUs) across the Philippines. METHODS: We conducted a national survey of NICUs in the Philippines. Institutions were classified according to sector (private/public), region and level. Respondents were asked about unit capacity, availability of ventilators and surfactant, resuscitation practices and estimated survival rates for EPIs of different gestational ages. RESULTS: Respondents from 103/228 hospitals completed the survey (response rate 45%). Public hospitals reported more commonly experiencing shortages of ventilators than private hospitals (85%vs23%, p<0.001). Surfactant was more likely to be available in city hospitals than regional/district hospitals (p<0.05) and in hospitals classified as Level III/IV than I/II (p<0.05). The financial capacity of parents was a major factor influencing treatment options. Survival rates for EPIs were estimated to be higher in private than public institutions. Resuscitation practice varied; active treatment was generally considered optional for EPIs from 25 weeks' gestation and usually provided after 27-28 weeks' gestation. CONCLUSION: Our survey revealed considerable disparities in NICU resource availability between different types of hospitals in the Philippines. Variation was observed between hospitals as to when resuscitation would be provided for EPIs. National guidelines may generate greater consistency of care yet would need to reflect the variable context for decisions in the Philippines.

Decision-making around resuscitation of extremely preterm infants in the Philippines: A consensus guideline.

While the vast majority of preterm births globally occur in low- and middle-income countries, existing published guidelines relating to the decision-making and resuscitation of extremely preterm infants (EPIs) largely focus on high-income countries. In 2018-2019, a working group of the Philippine Society of Newborn Medicine aimed to develop the first national guideline relating to the care of EPIs. The working group reviewed data on the outcomes of EPIs in the Philippines, surveyed paediatricians and neonatologists in the Philippines about current practice and held a consensus workshop. This paper describes the guideline development process and presents a summary of the guidelines. The national guidelines endorse consistency in decision-making. Health professionals should take into consideration the views and wishes of the infant's parents and the availability of resources to treat the newborn infant. Active management would be appropriate to provide for potentially viable preterm infants at moderate to high risk of poor outcomes, where parents have expressed their wish for this management (and where there are resources available to provide this treatment). For such infants, where parents have expressed their wish to withhold active management, palliative management would also be appropriate to provide. The guideline endorses a grey zone for neonatal resuscitation from approximately 24 to 28 weeks' gestation in the Philippines, reflecting the context for resuscitation in low- and middle-income countries. Disparities in resource availability are themselves an ethical concern for neonatologists and should be a stimulus for advocacy and improvements in health-care delivery.

Animal and clinical trials on a prototype, pressure limited, time cycled Philippine ventilator (PhilVent)

OBJECTIVE:To test the efficacy and safety of PhilVent™, a pressure limited, time cycled, Philippine ventilator through animal and clinical studies. METHODS AND RESULTS: Animal study: Term, newborn piglets (N=8) were intubated and alternately cycled to the PhilVent™ or to a pressure limited, time cycled, commercial ventilator (Sechrist) at peak inspiratory pressures of 10, 13 and 15 cm H20 and rates of 15, 20, 25 breaths per min and constant FiO2 (0.40) and positive end expiratory pressure (+4). Blood gases and adverse events (pneumothorax, sudden deterioration, death) were monitored. Results show no significant difference in blood gases on either machine at the various ventilator settings. No adverse events occurred. Clinical study: Prospective, randomized, controlled trial of 90 preterm infants with respiratory distress, randomized either to PhilVent™ (N=45) or Sechrist (N=45). Ventilator settings were adjusted to achieve predetermined range of blood gases. Arterial blood gases and any adverse events e.g., pneumothorax, pulmonary hemorrhage were monitored. There were no clinically significant differences in the ventilator settings or blood gases of the infants on the PhilVent™ or Sechrist. No increase in adverse events were noted with the PhilVent™. CONCLUSION: In animal and clinical studies, the efficacy and safety of the PhilVent were comparable to the Sechrist. The PhilVent™ is an effective, alternative ventilator for the treatment of respiratory insufficiency in newborn infants.