DATA SOURCES: The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included.
RESULTS: A total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children was dose and age.
CONCLUSIONS: This review highlighted that off-label prescribing in children was found to be highly prevalent throughout the past two decades, persistently in the neonatal intensive care units. This suggests that besides legislative and regulatory initiatives, behavioural, knowledge aspects and efforts to integrate evidence into practice related to off-label prescribing also need to be evaluated and consolidated as part of the concerted efforts to narrow the gaps in prescribing for children.
DESIGN: A quasi-experimental and longitudinal study was conducted among mothers with premature infants.
METHODS: Forty-eight mother-infant dyads were enrolled per arm in the control and experimental groups. The control group received standard routine care, while the experimental group received a maternal kangaroo care education program. Data were collected through self-administered Kangaroo Care Questionnaires. Chi-square, the general linear model and repeated measures ANOVA were used to analyse data.
RESULTS: The demographics are a majority of Malay mothers with multipara, a caesarean delivery with prematurity. At 3 months post-intervention, the experimental group reported a significant reduction in stress, a positive perception and good knowledge towards kangaroo care implementation. The mothers' perceived barriers towards kangaroo care significantly decreased after 3 months in the experimental group.
METHODS: The Director of each NICU was requested to complete the e-questionnaire between February 2019 and August 2021.
RESULTS: We received 848 responses, from all geographic regions and resource settings. Variations in most thermoregulation and golden hour practices were observed. Using a polyethylene plastic wrap, commencing humidity within 60 min of admission, and having local protocols were the most consistent practices (>75%). The odds for the following practices differed in NICUs resuscitating infants from 22 to 23 weeks GA compared to those resuscitating from 24 to 25 weeks: respiratory support during resuscitation and transport, use of polyethylene plastic wrap and servo-control mode, commencing ambient humidity >80% and presence of local protocols.
CONCLUSION: Evidence-based practices on thermoregulation and golden hour stabilisation differed based on the unit's region, country's income status and the lowest GA of infants resuscitated. Future efforts should address reducing variation in practice and aligning practices with international guidelines.
IMPACT: A wide variation in thermoregulation and golden hour practices exists depending on the income status, geographic region and lowest gestation age of infants resuscitated. Using a polyethylene plastic wrap, commencing humidity within 60 min of admission and having local protocols were the most consistent practices. This study provides a comprehensive description of thermoregulation and golden hour practices to allow a global comparison in the delivery of best evidence-based practice. The findings of this survey highlight a need for reducing variation in practice and aligning practices with international guidelines for a comparable health care delivery.
METHOD: A prospective observational study of outcome of all VLBW infants born between 1 January 1993 and 30 June 1993 and admitted to the NICU.
RESULTS: Data of 868 VLBW neonates from 18 centres in Malaysia were collected. Their mean birthweight was 1223 g (95% confidence intervals: 1208-1238 g). Thirty-seven point four per cent (325/868) of these infants died before discharge. After exclusion of all infants with congenital anomalies (n = 66, and nine of them also had incomplete records) and incomplete records (n = 82), stepwise logistic regression analysis of the remaining 720 infants showed that the risk factors that were significantly associated with increased mortality before discharge were: delivery in district hospitals, Chinese race, lower birthweight, lower gestation age, persistent pulmonary hypertension of the newborn, pulmonary airleak, necrotizing enterocolitis of stage 2 or 3, confirmed sepsis, hypotension, hypothermia, acute renal failure, intermittent positive pressure ventilation, and umbilical arterial catheterization. Factors that were significantly associated with lower risk of mortality were: use of antenatal steroid, oxygen therapy, surfactant therapy and blood transfusion.
CONCLUSION: The mortality of VLBW infants admitted to the Malaysian NICU was high and was also associated with a number of preventable risk factors.
BACKGROUND: Vulnerable premature infants commonly require special care in the NICUs. In most cases, prolonged hospitalization results in stress and anxiety for the mothers.
METHODS: A non-probability convenience survey was used in a public hospital, with 180 mothers completing the 26-item Perceived Stress Scale (PSS) and a 40-item State-Trait Anxiety Inventory (STAI).
RESULTS: 56.5% of mothers had high levels of stress, 85.5% of mothers had a high level of state-anxiety and 67.8% of mothers had a high level of trait-anxiety. The stress experienced by these mothers had a significant relationship with anxiety, and was found to be associated with state and trait anxiety levels, but not with maternal and infant characteristics.
CONCLUSION: Mothers in this setting revealed high levels of stress and anxiety during their premature infants' NICU admission. An immediate interventional programme focusing on relieving mothers' anxiety and stress is needed to prevent maternal stress and anxiety at an early stage.
METHODS: This was a retrospective study of data from 37 NICUs in the Malaysian National Neonatal Registry in 2012. All newborns with gestational age ≥ 36 weeks, without major congenital malformations and fulfilling the criteria of HIE were included.
RESULTS: There were 285,454 live births in these hospitals. HIE was reported in 919 newborns and 768 of them were inborn, with a HIE incidence of 2.59 per 1,000 live births/hospital (95% confidence interval [CI] 2.03, 3.14). A total of 144 (15.7%) affected newborns died. Logistic regression analysis showed that the significant predictors of death were: chest compression at birth (adjusted odds ratio [OR] 2.27, 95% CI 1.27, 4.05; p = 0.003), being outborn (adjusted OR 2.65, 95% CI 1.36, 5.13; p = 0.004), meconium aspiration syndrome (MAS) (adjusted OR 2.16, 95% CI 1.05, 4.47; p = 0.038), persistent pulmonary hypertension of the newborn (PPHN) (adjusted OR 4.39, 95% CI 1.85, 10.43; p = 0.001), sepsis (adjusted OR 4.46, 95% CI 1.38, 14.40; p = 0.013), pneumothorax (adjusted OR 4.77, 95% CI 1.76, 12.95; p = 0.002) and severe HIE (adjusted OR 42.41, 95% CI 18.55, 96.96; p < 0.0001).
CONCLUSION: The incidence of HIE in Malaysian NICUs was similar to that reported in developed countries. Affected newborns with severe grade of HIE, chest compression at birth, MAS, PPHN, sepsis or pneumothorax, and those who were outborn were more likely to die before discharge.