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.

Animal ; Male ; Female ; Infant Newborn ; Animals ; Blood Gas Analysis ; Gases ; Infant, Newborn ; Infant, Premature ; Philippines ; Pneumothorax ; Positive-pressure Respiration ; Prospective Studies ; Respiratory Insufficiency ; Ventilators, Mechanical ; Respiratory Distress Syndrome, Newborn ; Respiratory Insufficiency ; Equipment And Supplies

Objective: To determine the effectiveness of Kangaroo Mother Care (KMC) in increasing the rate of weight gain and decreasing hypothermia, apnea, and sepsis rate, and shorten hospital stay among low-birth-weight infants. Methods: Very low birth weight (VLBW) infants (≤1500 grams) were randomized to either the KMC or conventional care group. KMC provided skin-to-skin contact at least 6 hours per day while the conventional group received the usual care in the newborn intensive care unit (NICU). Daily weight measurements and weekly measurements of length, head, and chest circumference were recorded until discharge. Occurrence of hypothermia, apnea, sepsis, and length of stay was noted. Results: KMC group had a higher mean weight gain per day (p=0.0102). There was no difference in the length, head, and chest circumference between the two groups. Sepsis and apnea rates were not significant between the two groups. Significantly more neonates experience hypothermia in the control group (p<0.0069). Conclusion KMC is effective in increasing the weight per day compared with the control group. KMC protects the neonates against hypothermia. There is not enough evidence to show a difference in the incidence of sepsis, apnea, and the length of hospital stay between the two groups.
Kangaroo-Mother Care Method ; Infant, Low Birth Weight ; Weight Gain

Objective: To compare the physiologic status of infants before and after receiving kangaroo mother care (KMC) through assessment of their heart rate (HR), respiratory rate (RR), temperature, oxygen saturation, and pain scores. Methods: We conducted a retrospective study by chart review of all low-birth weight (LBW) infants enrolled in the KMC program of a tertiary medical center. Significance is defined by lower HR, RR, PIPP score and FLACC scale, and significant increase in temperature and oxygen saturation (within normal range) after 4 hours after each KMC session. Results: Out of the 46 LBW weight infants enrolled in the KMC program, only 23 infants had complete chart entries. A total of 99 KMC sessions were analyzed. There was no significant difference in the HR (p = 0.331), RR (p = 0.453), oxygen saturation (p = 0.839), and PIPP (p = 0.387)/FLACC (p = 0.13) scores among the LBW infants before and after the KMC session. However, there was a significantly higher axillary temperature (within normal range) four hours after KMC (p = 0.044). Conclusions KMC is associated with better thermoregulation even at four hours after the KMC session compared to four hours before. Other physiologic parameters such as heart rate, respiratory rate, oxygen saturation and pain scores were similar four hours before and after the KMC session.
Kangaroo-Mother Care Method ; Body Temperature Regulation

Objectives: To determine the effect of kangaroo mother care (KMC) on anxiety and depression of mothers of low-birth-weight neonates during the immediate newborn period. Method: Eligible participants were mothers of low-birth-weight infants (birth weight ≤2500 grams) admitted at a tertiary hospital's neonatal intensive care unit. Mothers were instructed on providing KMC daily to their infants during the study period (first seven days of life). Main Outcome Measure(s): The primary study outcome was the effect of KMC in improving maternal anxiety and depression scores in the immediate postpartum period using the locally validated Hospital Anxiety and Depression Scale-Pilipino (HADS/HADS-P). Results: A total of 171 mothers were enrolled in the study. Only 79 mothers provided KMC, and the rest (92) did not provide KMC. The anxiety and depression scores improved significantly from day 1 to 7 postpartum in both groups (p<0.05). Frequency of mothers categorized as having severe anxiety significantly decreased over time whether they provided KMC or not (KMC: 40.5%, 13.9%, 7.6% at Day 1 and 7 postpartum and day of discharge; No KMC: 35.9% and 27.2% at Day 1 and Day 7 postpartum). There was a significant reduction in the percentage of mothers categorized in the depressed group from Day 1 to Day 7 postpartum, among those who rendered KMC compared with those who did not (KMC: 7.6%, 2.5%, 0% at Day 1 and 7 postpartum and at the day of discharge vs. No KMC: 7.6% and 10.9% at Day 1 and 7 postpartum). There were no significant differences in the anxiety and depression scores at any period between mothers who rendered KMC > 6 hours and KMC ≤ 6 hours/day. Conclusion Anxiety and depression scores significantly decreased over time in both mothers who rendered and did not render KMC to their infants. However, there was a significant reduction in the percentage of mothers categorized as having severe depression over time among those who rendered KMC compared to those who did not. Other factors aside from KMC may affect the maternal anxiety and depression states, such as instability of the infant.
Kangaroo-Mother Care Method ; Intensive Care Units, Neonatal ; Depression ; Anxiety

Background: Transporting preterm neonates soon after birth entails risks. Only one study among many about the beneficial effects of Kangaroo Mother Care (KMC) had cited it as a safe and effective alternative to transport incubators. Objective: To determine if KMC transport could be an alternative to transport incubators by comparing the physiological outcomes of the two transport methods. Methods: This is a parallel non-blinded randomized-controlled trial funded by KMC Foundation, Philippines, Inc, of physiologically stable preterm neonates weighing ≤ 2200 grams delivered at a tertiary government hospital from September 10, 2011, to April 18, 2012. After obtaining written consent from their mothers, participants were randomly assigned to either the intervention or control group. The intervention groups were transported from the delivery room to the NICU while on skin-to-skin contact with the caregiver. In contrast, those in the control group were placed in a transport incubator. Vital signs, oxygen saturation, and blood glucose were measured before transport and upon NICU arrival. Adverse effects were monitored. Data were recorded using a standard database. Results: Ninety-two participants were recruited, forty-six in each arm. Two dropped out. The mean change in heart rate in the KMC transport decreased by 1.6 beats per minute; respiratory rate decreased by 0.18 breaths per minute, the temperature increased by 0.01°C, oxygen saturation decreased by 0.07%, blood glucose decreased by 5.07 mg/dL. The measured physiological parameters were not statistically significant between the two groups. In the KMC transport, there was a decreasing trend in the incidence of hypothermia, hypoglycemia, tachypnea, and tachycardia. Conclusion There are no significant differences in the heart rate, respiratory rate, temperature, oxygen saturation, and blood glucose levels among preterm neonates on KMC transport compared with preterm neonates on transport incubators, which is the current standard of care. The study showed that KMC transport is equally effective as a transport incubator. Hence, in low-resource settings, KMC transport may be used as a safe and effective neonatal transport.
Kangaroo-Mother Care Method ; Incubators

Background: Prematurity is a major cause of neonatal death. Continuous positive airway pressure (CPAP) is the recognized initial intervention among preterm neonates in respiratory distress. Kangaroo mother care (KMC) may help improve neonatal outcomes. Objective: To determine the effectiveness of KMC in reducing morbidity and mortality among preterm neonates on CPAP via RAM nasal cannula (nCPAP). Methods: A prospective, non-blinded, randomized controlled trial was conducted on eligible preterm neonates requiring nCPAP due to respiratory distress. They were randomly allocated to either KMC (n=35) or conventional care groups (n=35). Outcome measures included duration of nCPAP and oxygen support, physiologic parameters, morbidity, mortality, and length of hospital stay. Results: The durations of nCPAP and oxygen support were both significantly shorter in the KMC group. Morbidities (air leak syndrome, necrotizing enterocolitis, and late-onset sepsis) were also significantly lower in the KMC group. Although the mortality rate and the hospital stay were lower in the KMC group, these were not statistically significant. Conclusion KMC effectively decreased the duration of nCPAP and oxygen support, as well as the incidence of neonatal morbidities. There were trends towards reduced mortality and length of hospital stay in the neonates who received KMC.
Kangaroo-Mother Care Method ; Continuous Positive Airway Pressure

Background: Kangaroo Mother Care (KMC) is the standard of care for stable low birth weight infants. Provision of KMC to intubated preterm infants may also be beneficial, but strong evidence is still lacking. Objective: To determine the effectiveness of KMC in decreasing mortality among intubated preterm neonates. Study Design: This is a non-blinded, parallel, non-inferiority randomized controlled trial. Methodology: All intubated, preterm admissions, 28-36 weeks gestation, weighing 600-2000 grams, with respiratory distress were included. They were randomized to the intervention group who received KMC for 2-4 hours daily while intubated and the control group who received care inside an incubator. Participants’ physiologic status – before, during, and after the intervention – was recorded. The primary outcome was mortality. Secondary outcomes included comorbidities, days intubated, and hospital stay. Results: There was a total of 32 patients. The risk of dying in the KMC group (n=16) was significantly reduced by 78% (RR 0.22; 95% CI 0.06 - 0.87 p=0.009). The KMC patients were also less likely to have hypothermia, nosocomial pneumonia, NEC, and late-onset neonatal sepsis (p<0.05). The KMC group had higher blood sugar levels (110 vs. 58, p=0.001) and required fewer days of intubation (3.5 vs.1.5 days, p<0.000) compared to the control group. There was no difference in the duration of the hospital stay. Conclusion KMC is effective in decreasing mortality among intubated preterm neonates. Other comorbidities and days of intubation were also reduced.
Kangaroo-Mother Care Method ; Infant Mortality

Background. Indomethacin has been the gold standard for the closure of patent ductus arteriosus (PDA). Still, the availability of the intravenous (IV) form has been a big issue precluding its use in the Philippines. IV ketorolac is another non-steroidal anti-inflammatory drug (NSAID) that is cheaper and more available in our country and used for post-cardiac surgery pain management among neonates.

Objectives. To compare the efficacy of ketorolac versus indomethacin in the closure of patent ductus arteriosus among preterm infants.

Methods. We conducted a randomized controlled, double-blind, crossover design, non-inferiority trial on the use of iindomethacin versus ketorolac among preterm infants with PDA. We enrolled preterm infants at 5-12 days postnatal life, diagnosed with PDA by echocardiography at the Philippine General Hospital (PGH). We excluded infants with upper gastrointestinal bleeding, renal failure, birthweight < 500 grams, septic shock, and lethal anomalies. Patients were randomly allocated between two treatment groups (indomethacin versus ketorolac). The primary outcome measure was PDA closure measured after the treatment course. Adverse events like oliguria and bleeding were recorded.

Results. A total of 27 preterm infants were randomly assigned to the indomethacin (0.2 mg/kg/dose) and ketorolac (0.6 mg/kg/dose) group. Ketorolac has a 60% success rate for PDA closure (9/15) compared to indomethacin 41.67% (5/12) (p=0.154). No renal insufficiency and bleeding diathesis were noted. Five patients died in the study, four in the group initially allocated in ketorolac and one in indomethacin. Causes of death were late-onset sepsis, bronchopulmonary dysplasia, and congenital adrenal hyperplasia.

Conclusion. The success rate of PDA closure between IV ketorolac and IV indomethacin was not significantly different. There was neither oliguria nor bleeding observed in both groups.

Ductus Arteriosus, Patent ; Ketorolac ; Indomethacin

Background: The Philippine General Hospital (PGH) implemented the Kangaroo Mother Care (KMC) Program in 2014, recognizing its benefits in helping low birth weight (LBW) infants survive. Objective: To determine the acceptability and compliance of the stakeholders to the KMC program after one year from implementation. Method: Data were obtained from the NICU Annual statistics, KMC data forms, logbooks, and questionnaires to the stakeholders-doctors rotating at the NICU, NICU nurses, and mothers enrolled in the KMC program. Results: One year into the KMC program implementation, the KMC enrollment increased from 57% in 2014 to 75% in 2015. All mothers enrolled in the program said that they received their KMC knowledge from the health providers and firmly believed that KMC benefited them and their infants. The mothers also became more confident in taking care of their babies after each KMC encounter. Although only 50% said they would continue KMC at home, 85% proceeded. Furthermore, both doctors and nurses believed that KMC was beneficial to both mothers and infants, decreased hospital cost and nursing workload. KMC provision was 0.5-6 hours/day. Also, less than half of the data forms were accomplished. The KMC program was acceptable to all stakeholders who believed in the benefits of KMC to preterm infants. The mothers were very receptive and continued KMC even after discharge. However, there was sub-optimal engagement provided by the health providers with the mothers. There was also low adherence to recommended duration of KMC per day provided by the mothers. KMC data records were frequently not accomplished. PGH has instituted strategies to improve the KMC implementation by providing dedicated KMC rooms and supplying meals to mothers to increase KMC duration and frequency. A computer-based program for data entry was developed for the health providers, and a dedicated encoder was assigned. Conclusion KMC acceptability was high among stakeholders. Compliance increased after one year, with enrolment going up to 75%. However, adherence to the recommended KMC duration per day and accomplishment of data forms were still sub-optimal.
Kangaroo-Mother Care Method

Objectives. The effect of COVID-19 infection in pregnant women and her neonate is not well-understood, with no clear evidence for vertical transmission. This study aims to determine the maternal and neonatal clinical characteristics and the dyad’s outcomes among those infected with COVID-19 infection. Methods. An ambispective cross-sectional study involving pregnant women with confirmed COVID-19 infection was conducted at the Philippine General Hospital from April to August 2020. Two hundred nine obstetric patients were included, 14 of whom consented to specimen collection to determine vertical transmission. Results. The majority of pregnant women with COVID-19 infection and their neonates had good outcomes. Labor, delivery, and the immediate postpartum course were generally uneventful. The all-cause maternal morbidity rate was high at 75.6 per 100 cases during the five-month study period. COVID-19 related morbidities included the development of Guillain-Barré Syndrome. The in-hospital all-cause maternal mortality rate was 1.91 per 100 cases. The causes of maternal death were acute respiratory failure, septic shock, and congenital heart disease (atrial septal defect with Eisenmengerization). The in-hospital, all-cause neonatal mortality rate was 1.04 per 100 neonates of cases. The lone mother and infant deaths were in a postmortem rt-PCR swab negative mother with an rt-PCR swab positive live neonate who eventually succumbed after nine days of life. All 14 dyads with collected specimens that included amniotic fluid, placental tissue, umbilical cord, and neonate nasopharyngeal swab tested negative for SARS-CoV-2 rt-PCR. Conclusion. The prognosis for COVID-19 infected pregnant patients was generally good, with most of the patients discharged improved. Almost all of the neonates born to COVID-19-infected mothers were stable-term infants. There was no evidence for vertical transmission, as shown by negative rt-PCR results for all the additional specimens obtained. In general, the prognosis for COVID-19 infected dyads was good. The majority of the mothers were discharged well with their term infants. All possible maternal sources of COVID-19 infection to the neonate tested negative. This study provided no evidence for vertical transmission.
regnancy ; Female ; Infant, Newborn ; COVID-19 ; Family