Touzet Sandrine, Beissel Anne, Denis Angélique, Pillet Fabienne, Gauthier-Moulinier Hélène, Hommey Sophie, Claris Olivier
Hospices Civils de Lyon, Pôle Information Médicale Évaluation Recherche, Lyon F-69003, France Universite de Lyon, EA Laboratoire Health Services and Performance Research (HESPER) 7425, Lyon F-69008, France.
Hospices Civils de Lyon, Hopital Femme Mère Enfant, Department of Neonatal Intensive Care Unit, Bron F-69500, France.
BMJ Open. 2016 Apr 15;6(4):e010699. doi: 10.1136/bmjopen-2015-010699.
Oral feeding is a complex physiological process. Several scales have been developed to assess the ability of the neonate to begin suck feedings and assist caregivers in determining feeding advancement. However, feeding premature neonates remains an ongoing challenge and depends above all on caregivers' feeding expertise. We will evaluate the effect of a nurse training programme on the achievement of full oral feeding with premature neonates.
The study design will be an interrupted time series design with 3 phases: (1) A 6-month baseline period; (2) a 22-month intervention period and (3) a 6-month postintervention period. The intervention will consist of an educational programme, for nurses and assistant nurses, on feeding patterns in neonates. The training modules will be composed of a 2-day conference, 2 interactive multidisciplinary workshops, and routine practice nurse coaching. A total of 120 nurses and 12 assistant nurses, who work at the neonatal unit during the study period, will participate in the study. All premature neonates of <34 weeks postmenstrual age (PMA) will be included. The primary outcome will be the age of tube withdrawal PMA and chronological age are taken into account. The secondary outcomes will be the transition time, length of hospital stay, competent suckle feeding without cardiorespiratory compromise, rate of neonates presenting with feeding issues or feeding rejection signs, and current neonatal pathologies or deaths during hospital stay. A segmented regression analysis will be performed to assess the impact of the programme.
Approval for the study was obtained from the Hospital Ethics Committee, and the Institutional Review Board, as well as the French Data Protection Agency. The findings from the study will be disseminated through peer-reviewed journals, national and international conference presentations and public events.
NCT02404272 (https://clinicaltrials.gov).
经口喂养是一个复杂的生理过程。已经开发了几种量表来评估新生儿开始吸吮喂养的能力，并帮助护理人员确定喂养进展。然而，喂养早产儿仍然是一项持续的挑战，并且首先取决于护理人员的喂养专业知识。我们将评估一项护士培训计划对早产儿实现完全经口喂养的效果。
研究设计将采用中断时间序列设计，分为三个阶段：（1）为期6个月的基线期；（2）为期22个月的干预期；（3）为期6个月的干预期后阶段。干预措施将包括为护士和助理护士提供关于新生儿喂养模式的教育计划。培训模块将包括为期2天的会议、2次互动式多学科研讨会以及常规实践护士指导。在研究期间在新生儿病房工作的总共120名护士和12名助理护士将参与该研究。所有孕龄小于34周的早产儿都将被纳入。主要结局将是拔除鼻饲管时的孕龄（考虑孕龄和实际年龄）。次要结局将包括过渡时间、住院时间、无心肺功能不全的有效吸吮喂养、出现喂养问题或喂养拒绝迹象的新生儿比例，以及住院期间当前的新生儿疾病或死亡情况。将进行分段回归分析以评估该计划的影响。
该研究已获得医院伦理委员会、机构审查委员会以及法国数据保护局的批准。该研究的结果将通过同行评审期刊、国内和国际会议报告以及公共活动进行传播。
NCT02404272（https://clinicaltrials.gov）
