Pressure Injuries' Prevention in Newborn Infants Admitted to NICU Receiving Noninvasive Respiratory Support With Nasal Continuous Positive Airway Pressure (NCPAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Number of Pressure nasal injuries
研究概览
简要总结
Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support.
The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi.
The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU.
It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.
详细描述
Previous studies highlighted that nasal trauma, due to NCPAP support, is caused by the following risk factors:
- Very Low birth weight (< 1500 g)
- Gestational age < 32 weeks
- NCPAP duration > 5 days
- NICU stay of > 14 days
However, previous studies results are mixed regarding factors affecting nasal injuries in neonates supported with NCPAP.
Interventions indicated as protective are:
- Appropriate size of mask or nasal prongs and headbands
- Use of hydrocolloid as nasal barrier dressing
- A frequent alternation of the NCPAP device (nasal prongs or mask)
- A frequent assessment of skin integrity In this study a cohort of neonates (experimental group) will be prospectively enrolled and compared to a cohort of neonates born in 2018 (retrospective group) with similar characteristics. The NICU clinical procedures for skin integrity are similar for both cohorts but the experimental group will receive them with different frequency and modality based on previously defined risk factors that each newborn present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed from both parents or legally authorized representative
- •Infants receiving noninvasive respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) or Synchronized Nasal Intermittent Positive Pressure Ventilation (SNIPPV)
排除标准
- •Pre-existing nasal lesion
研究组 & 干预措施
Experimental group
All enrolled neonates will receive interventions that will be performed with different frequency and method according to newborns' risk factors, as well as the following standard interventions received by control group's newborns:
- appropriate use of hydrocolloid, headbands, masks and prongs
- frequently assess skin integrity
- humidity and heat gases
干预措施: interventional nursing care (Other)
Standard care
Newborns have received the interventions according to local protocol (standard nursing care) in 2018, as detailed in the "assigned intervention"
干预措施: Standard nursing care (Other)
结局指标
主要结局
Number of Pressure nasal injuries
时间窗: Through study completion, an average of 27 months
Evaluation of the number of pressure nasal injuries
次要结局
- Newborns' birth weight of the infants presenting nasal injuries and weight at presentation of nasal injury(Measured at the time of birth and at the time of presentation of nasal injury, an average of 2 months)
- Duration NCPAP treatment(From the beginning of NCPAP treatment until the end of NCPAP treatment, an average of 2 months)
- Infants' gestational Age (GA) presenting nasal injuries and postmenstrual age (PMA) at injury occurrence(Determined at the time of birth (GA) and at the time of nasal injury onset (PMA), an average of 2 months)
- Duration of NICU stay(From admission in NICU until NICU discharge or transfer in an other ward, an average of 2 months)