Multicenter randomized controlled trial of therapeutic hypothermia plus magnesium sulfate versus therapeutic hypothermia plus placebo in the management of term and near-term infants with hypoxic ischemic encephalopathy (The Mag Cool study): A pilot study
Bibliographic record
Abstract
Background: Therapeutic hypothermia provides up to 30% neuroprotection in moderate to severe hypoxic ischemic encephalopathy (HIE). Additional neuroprotection may be achieved by using concomitant pharmacologic neuroprotective agents. Aim: The aim was to evaluate the safety of concomitant neuroprotective therapy of therapeutic hypothermia and magnesium sulfate (MgSO 4 ) in the management of moderate and severe HIE in term and near-term infants. Study Design: Multicenter double-blind randomized controlled trial. Methodology: Term and near-term newborn infants (≥35 weeks) with a clinical diagnosis of moderate or severe HIE were randomized to either Arm A (therapeutic hypothermia plus MgSO 4 ) or Arm B (therapeutic hypothermia plus placebo) using a net-based randomization system. Both groups received, within 6 h of birth, standard hypothermia therapy (72 h of cooling to 33.5°C followed by slow rewarming over a period of 8 h) plus either MgSO 4 (250 mg/kg/dose ×3 doses) or placebo (normal saline). The groups were compared for short-term predischarge adverse outcomes. Results: A total of 60 patients were randomized (29 in Arm A and 31 in Arm B). Both groups had similar baseline characteristics (P > 0.05) including severity of HIE. There were no differences in the short-term adverse outcomes (death, seizures, thrombocytopenia, coagulopathy, renal failure, elevated liver function test's, hypotension, intracranial hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, persistent pulmonary hypertension, and pulmonary air leak syndromes) between the two groups (P > 0.05). Conclusions: The combined use of therapeutic hypothermia and MgSO 4 appears to be safe particularly with respect to maintaining normal blood pressure and coagulopathy. Long-term survival and neurodevelopmental outcomes remain to be evaluated.
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".