Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Sample size
研究概览
简要总结
The study was conducted as a randomized controlled study to determine effect of tube bathing on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in Gaziantep Cengiz Gökçek Maternity and Pediatrics Hospital and Kilis State Hospital Neonatal Intensive Care Units (NICU) among November 2019-September 2020. The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria. Accordingly, Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control). The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units. Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 0 Days 至 1 Month（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The baby is receiving phototherapy due to physiological hyperbilirubinemia,
- •Being a term newborn,
- •Monitoring of the LED group in the incubator and the tunnel group in the tunnel phototherapy device,
- •Parents' consent to participate in the study.
排除标准
- •Rh incompatibility between mother and baby,
- •Finding ABO non-compliance,
- •Positive direct Coombs test,
- •Presence of congenital anomaly or syndrome,
- •Any surgical intervention has been or will be made,
- •Having any skin lesions,
- •The need for mechanical ventilation.
结局指标
主要结局
Sample size
时间窗: 1-2 month
The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
Divided groups
时间窗: 1 month
Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
Experiment difining and time
时间窗: 12 month
The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units.
Measurement
时间窗: First, 6-12-24 hours for each nerwborn
Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Biochemical measurement
时间窗: First, 6-12-24 hours for each nerwborn
Total serum bilirubin values obtained from patient files.
TSB Findings
时间窗: 10 month
When differences regarding decrease in 24-hour total serum bilirubin (TSB) levels were compared in all relevant experimental groups, statistically differences were observed (p˂ .001). In particular, the levels of bilirubin were listed as LED-trial, Tunnel-trial, Tunnel-control and LED-control, respectively. It is worthy to utter herein that the decline in TSB was more notable in bathing groups.
Skin care findings
时间窗: 10 month
Skin integrity and moisture balance were better in bathing groups than control groups, the best was in the Tunnel-experimental group and the worst was in the Tunnel-control group (p˂ .001).
Conclusion
时间窗: 12 month
Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.
次要结局
未报告次要终点
研究者
SERAP ÖZDEMİR
Principal Investigator
Istanbul University - Cerrahpasa (IUC)