1.Development and Safety Trial of the OstreaVent2™ prototype for mechanically ventilated adult patients
Maria Esterlita T. Villanueva-Uy ; Enrique M. Ostrea, Jr. ; Alexander P. Paran ; Manuel C. Jorge ; Kriselda Karlene G. Tan ; Herbert G. Uy ; E. Vincent S. Faustino ; Robert O. Dizon
Acta Medica Philippina 2024;58(7):27-40
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 poststudy 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 thirdparty
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 No patient was withdrawn from the study.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.
Respiration, Artificial
2.Method validation study for SARS-CoV-2 viral RNA detection in cervical, rectal, amniotic fluid, placental, umbilical cord blood, and breastmilk specimens in a cohort of unvaccinated women in Manila, Philippines
Erlidia F. Llamas-Clark ; Mayan U. Lumandas ; Daniel C. Villarico ; Amalea Dulcene D. Nicolasora ; Maria Stephanie Fay S. Cagayan ; Emmanuel S. Baja ; Maria Esterlita T. Villanueva-Uy ; Paulyn Jean B. Rosell-Ubial ; Francisco M. Heralde III
Acta Medica Philippina 2024;58(15):32-38
OBJECTIVES
To validate a method in detecting SARS-CoV-2 via RT-qPCR in pregnant and non-pregnant samples other than nasopharyngeal swabs and/or oropharyngeal swabs such as cervical, rectal, amniotic fluid, placental, umbilical cord blood, and breastmilk.
METHODSWe performed a validation experiment using MGI easy extraction kits and BGI PCR kits on non-conventional specimens, including cervical, rectal, amniotic fluid, placental, umbilical cord blood, and breastmilk to detect and confirm the presence of SARS-CoV-2. In addition, we tested the validated method on 572 purposively sampled field-collected non-conventional specimens from a cohort of 109 unvaccinated pregnant and 47 unvaccinated non-pregnant women to assess which candidate non-conventional maternal- and fetal-associated specimens may contribute to maternal-fetal viral vertical transmission.
RESULTSPositive detection of SARS-CoV-2 viral RNA in non-conventional specimens was demonstrated and verified. Of the 572 non-conventional samples tested, 1.8% (10/572) were positively validated by RT-qPCR for SARS-CoV-2 in the maternal-associated specimens particularly the rectal (5), placental (1), and cervical (4) swabs among six pregnant and four non-pregnant individuals. In contrast, no SARS-CoV-2 viral RNA was detected in fetal-associated specimens.
CONCLUSIONThe results of the validation study may serve as an additional diagnostic screening layer to support maternal-child care. Furthermore, viral detection in these non-conventional maternal specimens may also be utilized to provide guidance in the clinical management of neonates, and pregnant women during delivery.
Philippines ; Sars-cov-2 ; Pregnant Women ; Umbilical Cord ; Amniotic Fluid ; Polymerase Chain Reaction ; Placenta
3.Comparison of ketorolac and indomethacin for the closure of patent ductus arteriosus among preterm infants born at the Philippine General Hospital: A randomized controlled crossover design.
Maria Esterlita T. Villanueva-Uy-UY ; Carmen R. Briones ; Edgardo M. Ortiz
Acta Medica Philippina 2022;56(9):84-88
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
4.A randomized controlled trial of intermittent kangaroo mother care versus conventional care in increasing the rate of weight gain among low-birth-weight neonates
Fay S. de Ocampo ; Maria Esterlita T. Villanueva-Uy
Acta Medica Philippina 2021;55(9):873-879
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
5.The physiologic status of low-birth-weight infants before and after kangaroo mother care sessions: A retrospective study
Erika Marie C. Peredo ; Maria Esterlita T. Villanueva-Uy
Acta Medica Philippina 2021;55(9):880-884
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
6.Effect of continuous versus intermittent Kangaroo Mother Care on weight gain and duration of hospital stay among low-birth-weight admitted at a level II NICU: A randomized control trial
Janelle Margaux M. Logronio ; Maria Esterlita T. Villanueva-Uy ; Socorro De Leon-Mendoza
Acta Medica Philippina 2021;55(9):885-892
Background:
The Neonatal Intensive Care Unit (NICU) admission at the Philippine General Hospital (PGH) exceeds total bed capacity. Decreasing admissions to the NICU would prevent overcrowding of patients, improve patient care, reduce hospital stay, and reduce predisposition to hospital-acquired infections.
Objective:
To determine the effect of continuous versus intermittent Kangaroo Mother Care (KMC) on weight gain and duration of hospital stay among low birth weight (LBW) neonates weighing 1,800 - 2,220 grams.
Methods:
Forty-six (46) stable LBW were randomized to either continuous (≥12 hours in the maternity ward) or intermittent (≤6 hours in the NICU step-down unit) KMC groups. Daily weight and weekly length, head and chest circumference until discharge, and duration of hospital stay were measured. Data were analyzed using the Mann-Whitney U-test and Fisher's exact test.
Results:
Infants in continuous KMC had an average weight gain of 50 grams/day (p=0.509) and had an average duration of hospital stay of 3 days (p=0.218). Results were not statistically different from intermittent KMC.
Conclusion
There was no evidence to show that weight gain and duration of hospital stay among infants in continuous KMC were significantly different from those in the intermittent KMC group.
Kangaroo-Mother Care Method
;
Infant, Low Birth Weight
7.Prolactin level and breastmilk production among mothers of low-birth-weight Infants admitted to level II Neonatal Intensive Care Unit
Jessica Anne A. Dumalag ; Maria Esterlita T. Villanueva-Uy ; Peter Francis Raguindin
Acta Medica Philippina 2021;55(9):893-897
Background:
Kangaroo mother care (KMC) has been proven by several studies to promote breastfeeding, but many of the studies focus on the success of exclusive breastfeeding, and less on its galactogenic effects.
Objective:
We aim to determine the maternal serum prolactin levels and breastmilk volume of mothers who rendered KMC to their infants.
Materials and Methods:
This is a randomized controlled, open-labeled, interventional study in the Neonatal Intensive Care Unit of a tertiary government hospital. Infants weighing < 2000 grams admitted in NICU Level II, together with medically stable mothers and no contraindication for breastfeeding were simultaneously enrolled. Primary outcome measures were maternal serum prolactin levels and expressed milk volume on day 3 and day 7 postpartum. Two-sample t-test was used to compare groups, and paired t-test to compare within groups. Tests were two-tailed, with a p-value of < 0.05 considered statistically significant.
Trial Registration:
Australia-New Zealand Clinical Trial Registry ID ACTRN12614000218695
Results:
Fifty mother-infant dyads were equally allocated into KMC and control groups (p < 0.001). There was significantly larger milk volume on the third day (29.6 ± 27.8 mL vs 16.3 ± 26.1 mL; p < 0.001) and seventh post-partum day (72.4 ± 62.3 mL vs 47.3 ± 43.8 mL; p < 0.000). There were increased serum prolactin levels compatible with post-partum state. The increase was more evident in the KMC (5244 ± 2702 mIU/L, on the 3rd postpartum day versus 4969 ± 2426 mIU/L, on the 7th postpartum day, p = 0.996) compared to control group (4129 ± 2485 mIU/L on the 3rd postpartum day versus 3705 ± 2731 mIU/L on the 7th postpartum day, p = 0.301).
Conclusion
We noted a significantly larger milk volume in the KMC group. There was also a greater increase in the prolactin levels in the KMC group, but this did not reach statistical significance. Further studies should be done to determine mechanism of galactogenesis through KMC.
Kangaroo-Mother Care Method
;
Prolactin
8.Effect of kangaroo mother care on the likelihood of breastfeeding from birth up to 6 months of age: A meta-analysis
Angelica Joyce A. Gacutno-Evardone ; Fay S. De Ocampo ; Maria Esterlita T. Villanueva-Uy
Acta Medica Philippina 2021;55(9):898-907
Background:
One of the World Health Organization (WHO) nutrition target by 2025 is 50% exclusive breastfeeding rate among infants until age 6 months. Kangaroo mother care (KMC) known to increase breastfeeding rates, especially in preterm and low birth weight (LBW) infants.
Objectives:
This study determined the effect of KMC to the rate of exclusive breastfeeding among preterm and LBW infants at 6 months of age.
Methods:
Conducted searches in MEDLINE and CENTRAL databases, likewise hand searched local publications December 1996 until June 2018. Included several randomized controlled trials and prospective observational studies comparing KMC and conventional care among preterm and LBW infants. The primary outcome was exclusive breastfeeding of infants at six months of age. Two authors independently assessed trial quality and extracted data the statistical analysis applied using Review Manager version 5.3.
Results:
Identified nine eligible trials involving 1,202 neonates. All studies had low-to-moderate risk of bias. KMC significantly noted to increase the likelihood of exclusive breastfeeding by 1.9 times at birth up to 6 months (OR 1.93 [1.18,3.17], p=0.009).
Conclusion
KMC can increase exclusive breastfeeding among preterm and LBW infants from birth up to 6 months of age.
Kangaroo-Mother Care Method
;
Breast Feeding
;
Infant, Low Birth Weight
9.Effect of kangaroo mother care on maternal anxiety and depression states at the neonatal ICU: A prospective cohort study
Nicole Rosalie Mallonga-Matilac ; Shary May Manuta-Baton ; Maria Esterlita T. Villanueva-Uy
Acta Medica Philippina 2021;55(9):916-922
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
10.Kangaroo mother care versus incubator in transporting stable preterm neonates: A randomized controlled trial
Renelyn P. Ignacio ; Maria Esterlita T. Villanueva-Uy
Acta Medica Philippina 2021;55(9):923-933
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


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