Obtaining assent for research involving children in Malaysia: a position statement from the Academy of Medicine of Malaysia College of Paediatrics.

The Academy of Medicine of Malaysia College of Paediatrics acknowledges the role of children in research and this position statement explores the ethical considerations in obtaining assent from minors in the Malaysian context. It highlights the importance in respecting children's agency and navigating cultural complexities. The College proposes flexibility in the minimum age for assent of at least nine years old, while emphasising the need for a tailored assent procedure. Addressing language and cultural diversities and expanding local empirical research on a formal assent process are some building blocks in developing a standardised nationwide process in obtaining assent from children.

Early-onset sepsis in Malaysian neonatal intensive care units.

OBJECTIVES: To determine the incidence, causative pathogens, morbidities, mortality, and risk factors associated with blood culture-positive early-onset sepsis (EOS, ≤72 hours of age) in symptomatic neonates admitted to the neonatal intensive care units (NICUs) of a middle-income country. STUDY DESIGN: Retrospective cohort study using data submitted prospectively to the Malaysian National Neonatal Registry (MNNR). SETTING: 44 Malaysian NICUs. PARTICIPANTS: All neonates born in 2015- 2020. RESULTS: EOS was reported in 991 neonates. The annual incidence of EOS increased from 0.46 to 0.49/1000 livebirths over the six years. The most common pathogen was Streptococcus agalactiae or Group B haemolytic streptococcus (GBS) (n=388, 39.2%), followed by Escherichia coli (E. coli) (n=80, 8.1%), Klebsiella spp (n=73, 7.4%), coagulase negative staphylococcus (CONS) (n=73, 7.4%), Pseudomonas spp (n=44, 4.4%) and methicillin-sensitive Staphylococcus aureus (n=34, 3.4%). The incidence of EOS due to GBS increased from 0.17 to 0.22/1000 livebirths. Morbidities and mortality were higher in those with EOS than without EOS. Multiple logistic regression analysis showed that Indian ethnic group, chorioamnionitis, gestation≥37weeks, female, spontaneous vaginal delivery, instrumental delivery, and surfactant therapy were significantly associated with increased risk of EOS due to GBS. Four factors were significantly associated with increased risk of non-GBS EOS (outborns, birthweight lt;1000 g, vaginal delivery, and surfactant therapy). Early continuous positive airway pressure was associated with significantly lower risk of EOS. CONCLUSION: The incidence of EOS showed an increasing trend in Malaysian NICUs. GBS was the most common causative pathogen. Several modifiable risk factors associated with EOS have been identified.

Haemoglobin Constant Spring (HbA2: c.427T>C) and Haemoglobin Adana (HbA2: c.179G>A) in jaundiced Malaysian term neonates with clinically significant hyperbilirubinemia.

INTRODUCTION: Haemoglobin Constant Spring (Hb CoSp) and Haemoglobin Adana (Hb Adana), are two non-deletion type of α-thalassemia reported in Malaysia. Owing to their structural instability, they cause hemolysis and hyperbilirubinemia. This observational study was part of a large study investigating multiple factors associated with severe neonatal jaundice. In this part we aimed to determine the prevalence of Hb CoSp and Hb Adana and their association with clinically significant neonatal hyperbilirubinemia (SigNH, total serum bilirubin (TSB>290µmol/L)) among jaundiced Malaysian term neonates. MATERIALS AND METHODS: The inclusion criteria were normal term-gestation neonates admitted consecutively for phototherapy. PCR-restriction fragment length polymorphism method was applied on DNA extracted from dry blood spot specimens of each neonate to detect for Hb CoSp and Hb Adana gene. Positive samples were verified by gene sequencing. RESULTS: Of the 1121 neonates recruited (719 SigNH and 402 no-SigNH), heterozygous Hb CoSp gene was detected in only two (0.27%) neonates. Both were SigNH neonates (0.3% or 2/719). No neonate had Hb Adana variant. CONCLUSION: Hb CoSp was not common but could be a risk factor associated with SigNH. No Hb Adana was detected.

Maternal and neonatal effects of Acinetobacter colonisation in preterm premature rupture of membrane and term labour.

INTRODUCTION: Some anecdotal reports suggest that maternal colonisation with Acinetobacter baumannii during pregnancy is associated with adverse maternal and neonatal effects, including preterm premature rupture of membrane (PPROM). The objective of this study was to compare the maternal and neonatal effects of A. baumannii colonisation in cases with PPROM and those with spontaneous onset of labour at term. METHODS: The recruitment of participants' was carried out at Selayang Hospital, Selangor, Malaysia. Vaginal swabs were prospectively taken from 104 patients of PPROM and 111 with spontaneous onset of labour at term. Swabs were also taken from the axillae and ears of their babies. These swabs were cultured to isolate A. baumannii. Maternal and neonatal adverse outcomes were documented. RESULTS: Sixteen mothers were A. baumannii positive, eight from each group respectively. None of the cases developed chorioamnionitis or sepsis. Those positive were four cases of PPROM and two babies of term labour. None of the babies developed sepsis. CONCLUSIONS: This study does not support the suggestion that A. baumannii colonisation during pregnancy is associated with adverse maternal and neonatal outcomes.

Randomized controlled study of the effects of different durations of light exposure on weight gain by preterm infants in a neonatal intensive care unit.

UNLABELLED: A randomized controlled study was carried out on 96 preterm infants (< 37 wk) with birthweight less than 2000 g admitted to a neonatal intensive care unit. The aim was to compare the weight gain between preterm infants exposed to 12 h cyclical lighting (intensity of light: 78.4 +/- 24.7 lux, mean +/- SD) and those exposed to a continuously dim environment (5.9 +/- 1.9 lux). The exclusion criteria were infants with major congenital malformations or who needed continuous lighting for treatment procedure and care. From day 7 of life until discharge, 50 infants were randomized to receive 12 h cyclical lighting and 46 infants to a continuously dim environment. There was no significant difference in the mean birthweight (12 h lighting vs continuously dim: 1482 vs 1465 g, p = 0.8), mean gestational age (31.6 vs 31.4 wk, p = 0.6), median duration of hospital stay (28.5 vs 28.5 d, p = 0.8), mean age to regain birthweight (13.0 vs 12.9 d, p = 0.3), mean weight gained by day 14 (27.6 vs 36.2 g, p = 1.0), median weight gain per day (11.9 vs 12.2 g, p = 0.9) or median body weight on discharge (1800 vs 1800 g, p = 0.4) between the two groups of infants. CONCLUSION: Exposing preterm infants to either 12 h cyglical lighting or continuously dim environment did not have any significant effect on their weight gain during the neonatal period.