METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.
RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.
CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
OBJECTIVES: We described the ROB profile of neonatal RCTs published since the 1950s.
METHODS: We analyzed individual studies within the Cochrane Neonatal reviews published up to December 2016. We extracted the reviewers' judgments on the ROB domains including random sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting. We evaluated blinding of personnel in trials in which blinding was considered feasible.
RESULTS: We assessed 1980 RCTs published between 1952 and 2016 from 294 Cochrane Neonatal systematic reviews, with full ROB assessments performed in 848 trials (42.8%). Among the ROB domains, the highest proportion of trials (73%) were judged as satisfactory ("low risk") in handling incomplete outcome data, while fewest trials achieved blinding of outcome assessor (38.4%). In the last 6 decades, a progressive increase has been observed in the proportion of trials that were rated as low risk in random sequence generation, allocation concealment, and selective reporting. However, blinding was achieved in less than half of the trials with no clear improvement across decades (23-44% since the 1980s).
CONCLUSIONS: Despite steady improvement in the overall quality of neonatal RCTs over the last 6 decades, blinding remained unsatisfactory in the majority of the trials.
METHODOLOGY: A prospective observational study carried out over a 2-year period between 2 September 1996 to 2 September 1998. For every training course conducted, the instructors completed a NRP course report form (Form A) that documented the instructors involved in the course. For every participant who attended the course and successfully completed it, the instructors submitted a record form (Form B) that contained the name, hospital address, department, profession, place of work, language used for training and the marks obtained by the individual participant. After each course, completed forms A and B were returned to the NRP secretariat for compilation.
RESULTS: Of the 37 core instructors, 35 (94.6%) carried out training courses in their respective home states. A further 513 new instructors and 2256 providers were trained subsequently. A total of 2806 health personnel from all 13 states of Malaysia were NRP-certified during the first 2 years. However, 61.2% (n = 335) of the 550 instructors were inactive trainers, having trained less than four personnel per instructor a year. Most of the NRP-certified personnel were either doctors (32.0%) or nursing staff (64.4%). More than 60% of these worked either in the labour rooms, neonatal intensive care units or special care nurseries. At least one person from all three university hospitals and all general hospitals, 89.3% (92/103) of the district hospitals, 3.5% (73/2090) of the maternal and child health services, and 21% (46/219) of the private hospitals and maternity homes, were trained in the NRP.
CONCLUSION: Dissemination of the NRP in Malaysia during the first 2 years was very encouraging. Further efforts should be made to spread the program to private hospitals and the maternal and child health services. In view of the large number of inactive instructors, the criteria for future selection of instructors should be more stringent.
Methods and analysis: This retrospective, comparative study of prospectively collected data in an ROP screening programme included infants indicated by gestational age ≤32 weeks, birth weight <1501 g, ventilation for 7 days or requiring oxygen >1 month, who underwent dilated fundoscopic examination from age 4 weeks, every 2 weeks until full retinal vascularisation. Infants with ROP were examined weekly and treated where indicated. Data were divided into two epochs. Epoch 1 oxygen saturation targets were [88-92%], epoch 2 targets [90-95% (99%)] with allowance of increase to 20% for several hours after procedures. Outcome measures included development of ROP, treatment, mortality, sepsis and intraventricular haemorrhage.
Results: A total of 651 infants underwent examination between 2003 and 2016. The incidence of ROP in epoch 1 was 29.1% and epoch 2 was 29.3% (p=0.24). ROP progression doubled in epoch 2 (5 vs 11%, p=0.006), proportion of cases treated halved (14% vs 6%, p=0.0005), sepsis was halved (78.5% vs 41.2%, p<0.0001) and intraventricular haemorrhage doubled (20.2% vs 43.8%, p=0.0001) in epoch 2. Mortality was 4% and 0% in epochs 1 and 2, respectively.
Conclusion: Incidence of ROP did not differ, although ROP cases that worsened doubled with higher oxygen targets. ROP cases requiring treatment decreased, as did sepsis and mortality. Intraventricular haemorrhage cases doubled.