Developing and testing a clinical care bundle incorporating caffeine citrate to manage apnoea of prematurity in a resource-constrained setting: a mixed methods clinical feasibility study protocol
Bibliographic record
Abstract
BACKGROUND: Apnoea of prematurity (AOP) is a common condition among preterm infants. Methylxanthines, such as caffeine and aminophylline/theophylline, can help prevent and treat AOP. Due to its physiological benefits and fewer side effects, caffeine citrate is recommended for the prevention and treatment of AOP. However, caffeine citrate is not available in most resource-constrained settings (RCS) due to its high cost. Challenges in RCS using caffeine citrate to prevent AOP include identifying eligible preterm infants where gestational age is not always known and the capability for continuous monitoring of vital signs to readily identify apnoea. We aim to develop an evidence-based care bundle that includes caffeine citrate to prevent and manage AOP in tertiary healthcare facilities in Kenya. METHODS: This protocol details a prospective mixed-methods clinical feasibility study on using caffeine citrate to manage apnoea of prematurity in a single facility tertiary-care newborn unit (NBU) in Nairobi, Kenya. This study will include a 4-month formative research phase followed by the development of an AOP clinical-care-bundle prototype over 2 months. In the subsequent 4 months, implementation and improvement of the clinical-care-bundle prototype will be undertaken. The baseline data will provide contextualised insights on care practices within the NBU that will inform the development of a context-sensitive AOP clinical-care-bundle prototype. The clinical care bundle will be tested and refined further during an implementation phase of the quality improvement initiative using a PDSA framework underpinned by quantitative and qualitative clinical audits and stakeholders' engagement. The quantitative component will include all neonates born at gestation age < 34 weeks and any neonate prescribed aminophylline or caffeine citrate admitted to the NBU during the study period. DISCUSSION: There is a need to develop evidence-based and context-sensitive clinical practice guidelines to standardise and improve the management of AOP in RCS. Concerns requiring resolution in implementing such guidelines include diagnosis of apnoea, optimal timing, dosing and administration of caffeine citrate, standardisation of monitoring devices and alarm limits, and discharge protocols. We aim to provide a feasible standardised clinical care bundle for managing AOP in low and middle-income settings.
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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 | 0.053 | 0.044 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.004 | 0.002 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.026 | 0.004 |
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".