Vasopressin versus epinephrine during cardiopulmonary resuscitation of asphyxiated newborns: A study protocol for a prospective, cluster, open label, single-center, randomized controlled phase 2 trial – The VERSE-Trial
Bibliographic record
Abstract
Introduction: Current neonatal resuscitation guidelines recommend the use of epinephrine during neonatal cardiopulmonary resuscitation (CPR). However, newborns receiving epinephrine continue to have high rates of mortality and neurodevelopmental disability. The infrequent need for neonatal CPR, coupled with an inability to consistently anticipate which newborn infants are at risk of requiring CPR, explains the lack of high-quality evidence (i.e., large randomized clinical trials) to better guide healthcare providers in their resuscitative effort. Therefore, we need neonatal data to determine the optimal vasopressor therapy during neonatal CPR. The current pilot trial will examine the efficacy of vasopressin versus epinephrine during CPR of asphyxiated newborn infants. Methods and analysis: The trial will be a prospective, cluster, open label, single-center, randomized controlled trial on two alternative cardiovascular supportive medications. This study will assess the primary outcome of time to return of spontaneous circulation (ROSC) in newborns requiring CPR in the delivery room who were treated with either vasopressin (intervention) or epinephrine (control). Secondary outcomes such as infant mortality and other clinical outcome measures will also be collected. An estimated 20 newborns will be recruited, and comparisons will be made between asphyxiated infants treated with either drugs. Ethics and dissemination: ClinicalTrial.gov Identifier: NCT05738148. Registered February 21, 2023.
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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 | 0.027 | 0.028 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.009 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.050 | 0.010 |
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".