A randomised controlled trial of hypertonic saline nose drops as a treatment in children with the common cold (ELVIS-Kids trial)
Bibliographic record
Abstract
Introduction: There are 17.2 billion upper respiratory tract infections (URTI) cases per year with no effective antiviral treatments. Hypertonic saline (HS) provides chloride ions for intracellular hypochlorous acid production as an innate antiviral mechanism. Aim: To investigate whether HS nose drops (2.6%) could reduce duration of illness in children age 0-6 years with a URTI. Methods: Otherwise healthy children were recruited when well or within 48 hours of URTI onset and randomised 1:1 to parent delivered HS nose drops (3 drops per nostril, ≥ 4 times per day until well) or usual care (UC) at onset of URTI. A daily diary for 28 days captured compliance, side effects and symptoms (Canadian Acute Respiratory Illness and Flu Scale (CARIF)). Nasal mid-turbinate swabs (daily for 5 days) detected 17 URTI viruses by respiratory PCR panel. Results: 407 children were randomised (206 HS, 205 UC) with intervention given to 301 who developed a URTI (HS 150, UC151). The HS group received a median of 5 days HS drops a median 3 times per day. Median duration of symptoms (DOS) was 2 days shorter with HS (HS 6 days, IQR 5-9, UC 8 days, IQR 5-11, p=0.004). DOS was reduced by HS where virus detected (HS n=102, median 6 days, IQR 5-8, UC 101, median 8, IQR 5-11, p=0.004), but not where virus was not detected (p=0.9). Rhinovirus the most common virus (HS n= 74/102, 73%). Fewer household contacts developed a URTI in the HS arm (n=66, 41%) vs UC (n=92, 58%), p=0.008. HS side effects of sneezing, runny nose and pain were infrequent and mild. No SAE. Conclusions: In children with URTI, HS nose drops reduced symptom duration by 2 days and onward transmission with a good safety profile.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".