DESIGN: Retrospective observational analysis.
SETTING: 56 acute stroke hospitals in eight countries.
PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.
OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.
RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.
CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.
DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.
OBJECTIVES: To assess the effects of reflective materials in combination with phototherapy compared with phototherapy alone for unconjugated hyperbilirubinaemia in neonates.
SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 11), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and the Cumulative Index of Nursing and Allied Health Literature (CINAHL), on 1 November 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials if the participants, who were term or preterm infants, received phototherapy with curtains made of reflective materials of any type in the treatment arm, and if those in the comparison arm received similar phototherapy without curtains or other intensified phototherapy, such as a double bank of lights.
DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS: Of 15 studies identified, we included 12 (1288 babies) in the review - 11 comparing phototherapy with reflective materials and phototherapy alone, and one comparing a single phototherapy light bank with reflective materials with double phototherapy. All reflective materials consisted of curtains on three or four sides of the cot and were made of white plastic (five studies), white linen (two studies), or aluminium (three studies); materials were not specified in two studies. Only 11 studies (10 comparing reflective materials versus none and one comparing reflective curtains and a single bank of lights with a double (above and below) phototherapy unit) provided sufficient data to be included in the meta-analysis. Two excluded studies used the reflective materials in a way that did not meet our inclusion criteria, and we excluded one study because it compared four different phototherapy interventions not including reflective materials. The risk of bias of included studies was generally low, but all studies had high risk of performance bias due to lack of blinding of the intervention. Three studies (281 participants) reported a decline in serum bilirubin (SB) (μmol/L) at four to eight hours (mean difference (MD) -14.61, 95% confidence interval (CI) -19.80 to -9.42; I² = 57%; moderate-certainty evidence). Nine studies (893 participants) reported a decline in SB over 24 hours and showed a faster decline in SB in the intervention group, but heterogeneity (I² = 97%) was too substantial to permit a meaningful estimate of the actual effect size (very low-certainty evidence). Subgroup analysis by type of reflective material used did not explain the heterogeneity. Exchange transfusion was reported by two studies; both reported none in either group. Four studies (466 participants) reported the mean duration of phototherapy, and in each of these studies, it was reduced in the intervention group but there was substantial heterogeneity (I² = 88%), precluding meaningful meta-analysis of data. The only two studies that reported the mean duration of hospital stay in hours showed a meaningful reduction (MD -41.08, 95% CI -45.92 to -36.25; I² = 0; moderate-certainty evidence). No studies reported costs of the intervention, parental or medical staff satisfaction, breastfeeding outcomes, or neurodevelopmental follow-up. The only study that compared use of curtains with double phototherapy reported similar results for both groups. Studies that monitored adverse events did not report increased adverse events related to the use of curtains, including acute life-threatening events, but other rarer side effects could not be excluded.
AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that the use of reflective curtains during phototherapy may result in greater decline in SB. Very low-certainty evidence suggests that the duration of phototherapy is reduced, and moderate-certainty evidence shows that the duration of hospital stay is also reduced. Available evidence does not show any increase in adverse events, but further studies are needed.
CONCLUSION: Ex-prematurity and the presence of an underlying illness results in escalation of the direct treatment cost of RSV chest infection. Current guidelines for use of passive RSV immunization do not appear to be cost-effective if adopted for Malaysian infants.
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.
METHOD: A retrospective analysis of the universal newborn hearing screening database from each hospital was performed. The database consisted of 28,432 and 30,340 screening results of babies born in 2015 and 2016, respectively. Quality indicators (coverage rate, referral rate, return for follow-up rate, and ages at screening and diagnosis) were calculated.
RESULTS: Overall coverage rate across the four hospitals was 75% in 2015 and 87.4% in 2016. Over the two years, the referral rates for the first screening ranged from 2.7% to 33.93% with only one hospital achieving the recommended benchmark of <4% in both years. The return for follow-up rates for each participating hospital was generally below the recommended benchmark of ≥95%. The mean age at screening was 3.9 ± 1.2 days and 3.3 ± 0.4 days, respectively. The mean age at diagnosis for 70 infants diagnosed with permanent hearing loss was 4.7 ± 0.7 months in 2015 and 3.6 ± 0.9 months in 2016.
CONCLUSIONS: Quality measures for the universal newborn hearing screening program in four public hospitals in Malaysia were lower than the required standards. Nevertheless, some quality indicators showed statistically significant improvements over the two years. Next steps involve identifying and implementing the best practice strategies to improve the outcome measures and thus the quality of the program.