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临床试验/NCT05005988
NCT05005988Unknown不适用

Actions for Empowered Maternal Neonatal Care (ACUNE): Nursing Intervention to Strengthen Mothers' Competence to Care for Their Preterm Infants at Home. A Pilot Study

Universidad de Antioquia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Change in the caregiver's competence

研究概览

简要总结

The quality of care premature infants receive at home after hospital discharge is critical to their health and well-being. Premature infants require special care, which is why Neonatal Intensive Care Units (NICUs) have processes in place to prepare mothers for discharge. However, this experience is very complex for mothers, who often experience high levels of stress, anxiety, sadness and uncertainty. Mothers need knowledge and skills about caring for a premature infant, but they also need to gain confidence, believe in their abilities, and become empowered to participate more actively and confidently in decisions that have to do with their child's health. Several approaches exist to prepare mothers for home-based infant care; in the present study, an intervention focused on empowerment is proposed as a way to strengthen mothers' competence to care for their preterm infants and improve infant health outcomes. The intervention is expected to have adequate acceptability and feasibility, as well as preliminary evidence that it improves mothers' competence to care for their infants and decreases readmissions, emergency department visits, improves weight gain and health outcomes of preterm infants.

详细描述

Premature children have a higher risk of becoming ill and dying than full-term children and that risk do not end with hospitalization, so the care they receive at home is decisive in their health and wellbeing. Preterm infants are especially vulnerable and have a greater number of readmissions and emergency visits after discharge, as well as delays in vaccination, infections as well as nutritional alterations.

Women play central in family health, and it is necessary to design and applying interventions to facilitate a woman's empowerment, specially to care premature son at home after Neonatal Intensive Care Units (NICU) discharge. Preparation for discharge has been described in the literature as a process where the mothers develop skills and knowledge that they will need to care for their premature children once they are at home. However, for mothers, they face a challenging task in which they experience high levels of stress, fear and uncertainty. Premature children require particular care and the mothers need more than knowledge and skills, they also need to get confidence, believe in their abilities and empowerment themselves to participate more actively and safely in decisions that have to do with the health of their children. This study arises from the need to prepare mothers through the possibilities of empowerment, as a way to improve the health outcomes of premature children. A Randomized Clinical Trial is proposed to establish the effect of the educational intervention of empowerment on mothers' competence in premature infant care, readmissions, weight gain, exclusive breastfeeding and other aspects related to the health, survival and well-being of premature infants. The intervention was designed by integrating the theoretical approach, empirical evidence and the results of a qualitative study in which mothers and fathers of premature infants participated, which gives a participatory approach to the research and makes it close to the parents' reality and gives it social relevance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcome evaluator will be external to the intervention and will not know whether the mothers belong to the intervention or control group. This person will be trained and standardized in the handling of the instruments, will know the general elements of the study, and will ensure compliance with the ethical conditions established in the study.

Outcome evaluator will be informed at the time of applying the instruments and recording the information related to the variables of interest of the study and will verify the complete filling out of the instruments.

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers of premature infants less than 37 weeks gestational age at birth.
  • Mothers of premature infants hospitalized in the neonatal intensive care unit

排除标准

  • Mothers with previous experience in caring for a premature infant.
  • Mothers whose children have some type of congenital malformation.

结局指标

主要结局

Change in the caregiver's competence

时间窗: At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.

The caregiver's competence is the capacity, ability and preparation that the caregiver has to perform his or her caregiving task at home and can be measured with the CUIDAR scale, which was designed and validated in Colombia. This scale has been used in several studies, confirming its validity and reliability. To determine the validity and reliability of the CUIDAR instrument in mothers of premature infants, a cross-sectional quantitative study was carried out in which its psychometric properties were measured. 207 mothers of premature infants participated. A factor analysis did not confirm the original structure in the new population, but a model with 7 factors and 33 items with a Cronbach's alpha of 0.852 and adequate goodness-of-fit indices. The new version of the scale, named CUIDAR-PreMa, has 7 dimensions: Acting, Coping, Bonding, Social Support, General Knowledge, Singularity and Specific Knowledge. The scale has 33 items, with a Likert-type scale

次要结局

  • Readmission(One week after the discharge)
  • Change in premature infant body weight(At admission (baseline), through hospitalization completion, an average of 3 week and one week after the discharge.)
  • Emergency visits(One week after discharge)
  • Exclusive breastfeeding(One week after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SANDRA PATRICIA OSORIO GALEANO

Principal Investigator

Universidad de Antioquia

研究点 (2)

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