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

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.

Use of caffeine for managing apneia of premature

“…It is extremely important to study the epidemiological characteristics of apnea of prematurity, as which alerts certain patients at high risk of developing this condition and, consequently, provides an earlier diagnosis, reducing the chances of hypoxemia and bradycardia that can lead to a severe disability and even death (Irimu et al, 2023).…”

“…The bibliography mentions that the risks involved with hypoxia, recurrent apnea and the threat of dysplasia bronchopulmonary disease is more deleterious than the risks involved with the therapy. The lack of it shows effects on cardiorespiratory function and neurocognitive outcome, such as changes in behavior and attention, which is very unfavorable in the long term (McDonald et al, 2018;Irimu, et al, 2023).…”

A Cafeína Como Droga De Primeira Escolha No Tratamento De Recém-Nascidos Prematuros Com Apneia

“…O qual para manter-se seguro e eficaz, deve ser preferencialmente administrado nas primeiras 24h após o nascimento e encerrada por volta da 34ª semana de IG, com dose de ataque (DA) padrão de 20 mg/kg e dose de manutenção (DM) 10 mg/kg. Nos casos em que a cafeína não apresente resultados pode ser necessário o uso de suporte ventilatório 7,11 .…”

“…A terapia com cafeína foi estudada e compreendida por diversos anos e por isso estudiosos afirmam que a droga não causa danos neurológicos ou prejuízos comportamentais. Os indivíduos submetidos ao fármaco foram avaliados até os 11 anos de idade e apresentaram melhora no desempenho a longo prazo em questões de coordenação motora fina e habilidades visuais 5,7 .…”