NCT01989026
A Randomized Trial of Providing BCG Vaccination Immediately
Ran, enrolled patients, then stopped for a reason unrelated to the science — flagged as possibly worth a second look.
- Phase
- PHASE4
- Enrollment
- 3,361
- Sponsor class
- OTHER
- Taxonomy code
- staff_site
What the registry says
“Major structural and organizational changes at the NICU”
What real verification found
This record was pre-classified as Category A ("unanswered problem" — stopped for a reason unrelated to science), but real research shows the scientific question WAS in fact answered by this exact trial; the CT.gov "has_results=false" flag is simply stale/never updated. Direct match found: Bjerregaard-Andersen M et al., "Immediate Bacille Calmette-Guérin Vaccination to Neonates Requiring Perinatal Treatment at the Maternity Ward in Guinea-Bissau: A Randomized Controlled Trial," The Journal of Infectious Diseases, Dec 2021, 224(11):1935-1944. PMID 33893799, DOI 10.1093/infdis/jiab220 (academic.oup.com/jid/article/224/11/1935/6249562). Match confirmation: - Design: parallel-group, open-label RCT, Guinea-Bissau NICU, BCG+OPV immediately-on-admission vs. BCG+OPV-at-discharge — exact match to the CT.gov study description for NCT01989026. - Sample size: 3,353 neonates randomized (1,676 intervention / 1,677 control) vs. the CT.gov record's enrollment=3361 (ACTUAL) — same order of magnitude, consistent with a handful of post-randomization exclusions in the analysis population. - Stop reason: the paper explicitly states the trial was "discontinued due to declining in-hospital mortality rates and major NICU restructuring" — this is essentially verbatim the CT.gov why_stopped text ("Major structural and organizational changes at the NICU"). - A separate downstream paper (Aaby/Benn group, "Maternal BCG Vaccine Scar Status..." lineage, PMC7520814) explicitly cites this same trial as "RCT IV" and states "trial registration number NCT01989026," with enrollment cited as 3354 — directly tying the NCT ID to the published paper. - Results: overall in-hospital mortality 3.1% (BCG) vs 3.3% (control); infection-specific deaths trended lower with BCG (14 vs 21); non-infectious deaths unaffected. Conclusion: immediate BCG+OPV was safe and may protect against fatal infection in frail neonates. So despite stopping early/for administrative (NICU restructuring) reasons unrelated to the science, and despite CT.gov never being updated to show posted results, the investigators did complete data collection, analyze, and publish a full peer-reviewed report answering the trial's primary question.
Full search & fetch trail
WebSearch: "NCT01989026 BCG vaccination NICU Bandim"; WebSearch: "BCG vaccination early neonatal mortality randomized trial Bandim Health Project Guinea-Bissau"; WebSearch: "\"Immediate Bacille Calmette-Guérin Vaccination to Neonates\" \"Guinea-Bissau\" NCT01989026 registration"; WebFetch on clinicaltrials.gov/study/NCT01989026 (failed to render full content — only header returned); WebFetch on pubmed.ncbi.nlm.nih.gov/33893799/ (retrieved abstract/design/N/conclusions); WebFetch on pmc.ncbi.nlm.nih.gov/articles/PMC7520814/ (confirmed explicit citation of NCT01989026 as "RCT IV" with N=3354 in a related Bandim Health Project publication).