Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, 35392, Giessen, Germany.
Department of Psychosomatic Medicine, Justus-Liebig-University, Feulgenstrasse 12, 35392, Giessen, Germany.
BMC Pediatr. 2023 Jul 7;23(1):344. doi: 10.1186/s12887-023-04165-0.
The therapeutic advances and progress in the care for preterm infants have enabled the regular survival of very immature infants. However, the high burden of lifelong sequelae following premature delivery constitutes an ongoing challenge. Regardless of premature delivery, parental mental health and a healthy parent-child relationship were identified as essential prerogatives for normal infant development. Family centered care (FCC) supports preterm infants and their families by respecting the particular developmental, social and emotional needs in the Neonatal Intensive Care Unit. Due to the large variations in concepts and goals of different FCC initiatives, scientific data on the benefits of FCC for the infant and family outcome are sparse and its effects on the clinical team need to be elaborated.
This prospective single centre longitudinal cohort study enrols preterm infants ≤ 32 + 0 weeks of gestation and/or birthweight ≤ 1500 g and their parents at the neonatal department of the Giessen University Hospital, Giessen, Germany. Following a baseline period, the rollout of additional FCC elements is executed following a stepwise 6-months approach that covers the NICU environment, staff training, parental education and psychosocial support for parents. Recruitment is scheduled over a 5.5. year period from October 2020 to March 2026. The primary outcome is corrected gestational age at discharge. Secondary infant outcomes include neonatal morbidities, growth, and psychomotor development up to 24 months. Parental outcome measures are directed towards parental skills and satisfaction, parent-infant-interaction and mental health. Staff issues are elaborated with particular focus on the item workplace satisfaction. Quality improvement steps are monitored using the Plan- Do- Study- Act cycle method and outcome measures cover the infant, the parents and the medical team. The parallel data collection enables to study the interrelation between these three important areas of research. Sample size calculation was based on the primary outcome.
It is scientifically impossible to allocate improvements in outcome measures to individual enhancement steps of FCC that constitutes a continuous change in NICU culture and attitudes covering diverse areas of change. Therefore, our trial is designed to allocate childhood, parental and staff outcome measures during the stepwise changes introduced by a FCC intervention program.
Clinicaltrials.gov, trial registration number NCT05286983, date of registration 03/18/2022, retrospectively registered, http://clinicaltrials.gov .
早产儿治疗的进步和护理的进展使得非常不成熟的婴儿能够正常存活。然而，早产儿出生后终生遗留的高负担仍然是一个持续存在的挑战。无论是否早产，父母的心理健康和健康的亲子关系被确定为正常婴儿发育的基本前提。以家庭为中心的护理（FCC）通过尊重新生儿重症监护病房中特定的发育、社会和情感需求，支持早产儿及其家庭。由于不同 FCC 计划的概念和目标存在很大差异，因此关于 FCC 对婴儿和家庭结局益处的科学数据很少，其对临床团队的影响需要进一步阐述。
本前瞻性单中心纵向队列研究纳入了德国吉森大学医院新生儿科的胎龄≤32+0 周和/或出生体重≤1500 克的早产儿及其父母。在基线期后，按照逐步的 6 个月方法实施额外的 FCC 措施，涵盖新生儿重症监护病房环境、工作人员培训、父母教育和父母的社会心理支持。招募计划在 2020 年 10 月至 2026 年 3 月的 5.5 年期间进行。主要结局是出院时的校正胎龄。次要婴儿结局包括新生儿发病率、生长和至 24 个月的精神运动发育。父母结局指标针对父母技能和满意度、父母-婴儿互动和心理健康。工作人员问题通过特别关注工作场所满意度进行阐述。使用计划-执行-研究-行动循环方法监测质量改进步骤，结果测量涵盖婴儿、父母和医疗团队。并行数据收集使我们能够研究这三个重要研究领域之间的相互关系。样本量计算基于主要结局。
将改善的结果测量归因于构成新生儿重症监护病房文化和态度持续变化的 FCC 的个别增强步骤在科学上是不可能的，该变化涵盖了广泛的变化领域。因此，我们的试验旨在通过 FCC 干预计划引入的逐步变化，分配儿童、父母和工作人员的结果测量。
Clinicaltrials.gov，试验注册编号 NCT05286983，注册日期 2022 年 3 月 18 日，回溯性注册，http://clinicaltrials.gov。
