Browsing by Author "Harrison, Michael"

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    A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
    (BioMed Central, 2023-09-19) Lategan, Ilse; Durand, David; Harrison, Michael; Nakwa, Firdose; Van Wyk, Lizelle; Velaphi, Sithembiso; Horn, Alan; Kali, Gugu; Soll, Roger; Ehret, Danielle; Zar, Heather; Tooke, Lloyd
    Introduction Respiratory distress syndrome in preterm infants is an important cause of morbidity and mortality. Less invasive methods of surfactant administration, along with the use of continuous positive airway pressure (CPAP), have improved outcomes of preterm infants. Aerosolized surfactant can be given without the need for airway instrumentation and may be employed in areas where these skills are scarce. Recent trials from high-resourced countries utilising aerosolized surfactant have had a low quality of evidence and varying outcomes. Methods and analysis The Neo-INSPIRe trial is an unblinded, multicentre, randomised trial of a novel aerosolized surfactant drug/device combination. Inclusion criteria include preterm infants of 27–34+6 weeks’ gestational age who weigh 900-1999g and who require CPAP with a fraction of inspired oxygen (FiO2) of 0.25–0.35 in the first 2–24 h of age. Infants are randomised 1:1 to control (CPAP alone) or intervention (CPAP with aerosolized surfactant). The primary outcome is the need for intratracheal bolus surfactant instillation within 72 h of age. Secondary outcomes include the incidence of reaching failure criteria (persistent FiO2 of > 0.40, severe apnoea or severe work of breathing), the need for and duration of ventilation and respiratory support, bronchopulmonary dysplasia and selected co-morbidities of prematurity. Assuming a 40% relative risk reduction to reduce the proportion of infants requiring intratracheal bolus surfactant from 45 to 27%, the study will aim to enrol 232 infants for the study to have a power of 80% to detect a significant difference with a type 1 error of 0.05. Ethics and dissemination Ethical approval has been granted by the relevant human research ethics committees at University of Cape Town (HREC 681/2022), University of the Witwatersrand HREC (221112) and Stellenbosch University (M23/02/004). Trial registration PACTR202307490670785
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    Early clinical signs in neonates with hypoxic ischemic encephalopathy predict an abnormal amplitude-integrated electroencephalogram at age 6 hours
    (BioMed Central Ltd, 2013) Horn, Alan; Swingler, George; Myer, Landon; Linley, Lucy; Raban, Moegammad; Joolay, Yaseen; Harrison, Michael; Chandrasekaran, Manigandan; Rhoda, Natasha; Robertson, Nicola
    BACKGROUND: An early clinical score predicting an abnormal amplitude-integrated electroencephalogram (aEEG) or moderate-severe hypoxic ischemic encephalopathy (HIE) may allow rapid triage of infants for therapeutic hypothermia. We aimed to determine if early clinical examination could predict either an abnormal aEEG at age 6 hours or moderate-severe HIE presenting within 72 hours of birth. METHODS: Sixty infants [greater than or equal to] 36 weeks gestational age were prospectively enrolled following suspected intrapartum hypoxia and signs of encephalopathy. Infants who were moribund, had congenital conditions that could contribute to the encephalopathy or had severe cardio-respiratory instability were excluded. Predictive values of the Thompson HIE score, modified Sarnat encephalopathy grade (MSEG) and specific individual signs at age 3-5 hours were calculated. RESULTS: All of the 60 infants recruited had at least one abnormal primitive reflex. Visible seizures and hypotonia at 3-5 hours were strongly associated with an abnormal 6-hour aEEG (specificity 88% and 92%, respectively), but both had a low sensitivity (47% and 33%, respectively). Overall, 52% of the infants without hypotonia at 3-5 hours had an abnormal 6-hour aEEG. Twelve of the 29 infants (41%) without decreased level of consciousness at 3-5 hours had an abnormal 6-hour aEEG (sensitivity 67%; specificity 71%). A Thompson score [greater than or equal to] 7 and moderate-severe MSEG at 3-5 hours, both predicted an abnormal 6-hour aEEG (sensitivity 100 vs. 97% and specificity 67 vs. 71% respectively). Both assessments predicted moderate-severe encephalopathy within 72 hours after birth (sensitivity 90%, vs. 88%, specificity 92% vs. 100%). The 6-hour aEEG predicted moderate-severe encephalopathy within 72 hours (sensitivity 75%, specificity 100%) but with lower sensitivity (p = 0.0156) than the Thompson score (sensitivity 90%, specificity 92%). However, all infants with a normal 3- and 6-hour aEEG with moderate-severe encephalopathy within 72 hours who were not cooled had a normal 24-hour aEEG. CONCLUSIONS: The encephalopathy assessment described by the Thompson score at age 3-5 hours is a sensitive predictor of either an abnormal 6-hour aEEG or moderate-severe encephalopathy presenting within 72 hours after birth. An early Thompson score may be useful to assist with triage and selection of infants for therapeutic hypothermia.
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    Neonatal Sepsis And Antibiotic Sensitivity Patterns At A South African Tertiary Nursery – Evolution Over A 15 Year Period
    (2019) Naidoo, Nayestha; Harrison, Michael; Horn, Alan
    Background Neonatal infection is an important cause of morbidity and mortality in babies. The causative pathogens and their antibiotic susceptibility patterns should be monitored so that treatment regimens can be adjusted to maintain efficacy and avoid selection of resistant organisms. Objectives To compare the incidence of culture positive neonatal sepsis; and to describe the pathogens and antibiotic resistance profiles for significant organsims over a 15-year period in a tertiary nursery in Cape Town. Methods Retrospective blood culture data for 12 months were collected at three time points over a 15-year period. Blood cultures from 2004, 2013 and 2017 were analysed. All neonates with growth on blood cultures were included. Results During 2004 a total of 817 (43.3% of total admissions) blood cultures were taken, 171 (9.1% of total admissions) were culture positive. The most common invasive organisms were Klebsiella pneumoniae (31.8% of invasive organisms), S.aureus (26.1%) and enterococcus species (7.3%). There were 102 contaminants (12.5% of total cultures) of which 7.8% were due to Coagulase-negative Staphylococcus (CONS). In 2013 a total of 1070 (46.8% of total admissions) blood cultures were taken, 124 (5.4% of total admissions) were culture positive. Common invasive organisms were Klebsiella pneumoniae (53.8% of invasive organisms), E. coli (12.8%) and S. aureus (10.3% ). Forty-six blood cultures were deemed contaminated (4.3% of all cultures) and of these 2.1% were due to CONS. In 2017, there were 581 blood cultures taken (26.5% of total admissions), 56 were culture positive (2.6% of total admissions). Commonly occuring invasive organisms were Klebsiella pneumoniae (32.4% of invasive organisms), Group B streptococcus (16.2%) and Acinetobacter (13.5%). Twenty-nine blood cultures were considered contaminated (5.6% of cultures) of which 1.7% were CONS. The gram-negative organisms showed an increasing resistance to penicillin, ampicillin and aminoglycosides but remained sensitive to carbapenems. Conclusions The initial reduction in positive blood cultures from 2004 to 2013 was primarily due to the reduction of contaminants, probably reflecting improved blood sampling techniques. The large reduction in Gram-negative organisms from 2013 to 2017 suggests improved infection control measures , but gram-negative organisms remained prominent in all three cohorts. Emergence of resistant organisms is concerning and in keeping with other nurseries worldwide. These data illustrate the need for antibiotic stewardship, infection control measures and ongoing surveillance.
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    Short-term outcomes of inborn vs out-born very low birth weight neonates (< 1500 g) in the Groote Schuur neonatal nursery
    (2018) Gibbs, Lyndal; Harrison, Michael
    Background and aim: The Groote Schuur Hospital (GSH) Neonatal Nursery provides Level 3 care for the Metro West Health District in the Western Cape. Worldwide, VLBW neonates have improved outcomes when delivered in Level 3 neonatal units, compared with those who are transported from other facilities. This study aims to identify the characteristics and clinical outcomes of our VLBW patients, with emphasis on differences between inborns and outborns. Methodology: A retrospective cohort study. VLBW neonates admitted to the GSH Neonatal Nursery between 1 January 2012 and 31 December 2013 were enrolled on the Vermont Oxford Network database and reviewed. Maternal and infant characteristics, and outcomes at the time of discharge from hospital were analysed. Results: A total of 1032 VLBW neonates were enrolled. 906 (87.8%) were delivered at GSH, and 126 (12.2%) were outborn. Access to antenatal care, antenatal steroids and inborn status were statistically significant predictors for mortality and survival without morbidity. The mothers of inborn patients were more likely to have received antenatal care (89.1% vs 57.9%, p <0.0001) and antenatal steroids (64.2% vs 15.2%, p <0.0001). Inborns required less ventilatory support (16.2% vs 57.9%, p <0.0001) and surfactant administration (25.3% vs 65.1%, p <0.0001). Inborns had a lower incidence of late infection (8.8% vs 23.4%, p <0.0001), severe intraventricular haemorrhage (3.7% vs 13.9%, p <0.0001) and chronic lung disease (5.3% vs 13.4%, p =0.003). The incidence of necrotising enterocolitis was similar between the two groups (5.9% vs 8.7%, p =0.227). 18.4% of inborns and 33.3% of outborns demised (p <0.0001), mostly on the first 2 days of admission. Mortality declined as birth weight increased. Of the survivors, 83.5% of inborns and 70.2% of outborns did not develop serious morbidity (p =0.003). Significant morbidity and mortality was noted in the outborn group weighing 800g and less, with only one outborn patient in the cohort surviving to discharge without major morbidity. Conclusion: VLBW neonates delivered at Groote Schuur Hospital had better outcomes than their outborn counterparts. Perinatal regionalisation is beneficial to our patients, with antenatal care, timeous in-utero transfer and antenatal steroids contributing to excellent outcomes.
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    Vaccination Of Preterm Infants: Knowledge And Practices Of Healthcare Workers In South Africa
    (2023) Nakibuka, Jesca; Harrison, Michael; Joolay Yaseen
    Objective: To determine practices and knowledge of healthcare workers (HCWs) regarding vaccination of preterm infants in South Africa (S.A) Study design: Online cross-sectional survey of HCWs involved in neonatal care in state and private neonatal intensive-care units in S.A. Results: A total of 245 health workers participated in the survey (36.4% response rate). Majority were paediatricians (35.9%), had more than 10 years practice (55.5%) and majority were from the public sector (62.9%). Up to 80.4% of the respondents correctly responded that preterm infants should be vaccinated according to the chronological age. The average knowledge score was 10 points out of 16 points. Factors associated with knowledge of preterm vaccination were current practice role, years of practice, facility location, and having a written policy. The private sector compared to the public sector had significantly higher proportion of written policies to guide on vaccination of preterm infants, systems to keep record of preterm vaccinations and systems to follow-up preterm infants who default on vaccination. Conclusion: Non-specialized health workers, those with fewer years of practice, those working in rural facilities and facilities with no written policy on preterm vaccination are more likely to have knowledge gaps in preterm vaccination. Inclusion of preterm vaccination in prequalification training of non-specialized cadres, knowledge transfer through mentorships, continuous medical education and written policies may improve preterm vaccination knowledge among health workers caring for preterm infants in South Africa.