Positive Feeding of the Preterm Infant - a Feasibility Study of a Developmental Supportive Feeding Strategy in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Recruitment rates and sample criteria
研究概览
简要总结
The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants.
The main questions it aims to answer are:
- Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit?
- Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit?
Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.
详细描述
The parents will be recruited before or as soon as possible after birth. The intervention will start as soon as the parents have given written consent for themselves and behalf of their infant.
The intervention is developed in line with the MRC framework of developing and evaluating complex interventions in an iterative and dynamic way. The intervention will be based on parents counseling and an infant feeding protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age of 28 weeks
- •post menstrual age of 28 weeks after transition from regional hospital
排除标准
- •diagnoses or malformations that makes eating difficult
- •triplets or more
- •parents not speaking/understanding Norwegian or English
- •parents with challenges or special needs for follow up
结局指标
主要结局
Recruitment rates and sample criteria
时间窗: Prospective over a period of 1 year
Variables to evaluate if we can recruit appropriate participants, the time frame it takes, the eligibility criterias, the recruitment routines.
Acceptability
时间窗: Prospective over a period of 1 year
Evaluation of acceptability of the intervention for the participants, adherence to the study procedures, the burden for participants and the health care personnell conducting the intervention, safety and adverse events
Data collection and outcome variables
时间窗: Prospective over a period of 1 year
How appropriate are the data collection procedures, the participants ability to complete the quiestionnaires, appropriatness of the amount of data collection, completion of datasets,
Resources and organisation
时间窗: Prospective over a period of 1 year
Evaluation of the resources needed to conduct the study procedures, resources needed for training health care personnel or other costs related to the study
次要结局
- Infant outcome variables(Prospective over a period of 1 year)