CTRI/2024/10/076075尚未招募1/2 期
Comparing the effect of no sponging versus daily sponging on incidence of late onset neonatal sepsis among very low birth weight (VLBW) neonates in neonatal intensive care unit: An open label randomized controlled trial
ABVIMS and Dr. RML Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月10日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of late onset neonatal sepsis among VLBW neonates in neonatal intensive care unit in both the groups.
研究概览
简要总结
- All inborn VLBW neonates and outborn VLBW neonates admitted in NICU within 72 hours of life will be eligible for the study. All eligible infants will be assessed for presence of any one or more of the exclusion criteria. If none of the exclusion criteria are met then these infants will be enrolled in the study. Eligible infants will be randomly assigned into two groups. No sponging and Routine sponging.
- The first sponging will be done once the newborn has achieved cardiorespiratory and thermal stability. A standardized procedure of sponging will be taught to all the nursing staff of NICU.
- For the purpose of the study, late onset sepsis will include clinical sepsis, probable sepsis and culture proven sepsis. Multiplex PCR for bacterial detection will be taken as a surrogate marker for culture positivity.
- Temperature will be recorded using peripheral and central thermistor probes installed in the incubators. When babies are in incubators with only one thermistor probe, peripheral temperature will be assessed by comparing it with the central temperature using back of the hand. Three standard measurements will be taken for each baby at 5min before sponging, 5 and 10 min after sponging. In babies whose temperature is not stabilized by 10 min, temperature will be checked every 10 min till temperature becomes 36.5 degree Celsius.
- Daily weight will be monitored using digital weighing scale and weekly weight gain will be compared.
- For assessing the physiological and behavioral components of stress, Premature infant pain profile PIPP-r will be used.
- Saliva will be collected for salivary cortisol measurements before sponging and 20 minutes following sponging on day 3 of life. Sponging will be done at 9AM to decrease the influence of natural cortisol peak occurring between 6AM-8AM, on salivary cortisol in sponging group. First sample will be collected for obtaining the baseline levels prior to the intervention and second sample will be collected post-intervention in the sponging group. Saliva samples from the non- sponged group will also be collected parallelly for baseline comparison.
- Composite outcome in terms of incidence of mortality or sepsis will be compared in both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •All VLBW neonates admitted to NICU within 72 hours of life.
- •With informed written consent.
排除标准
- •Known severe congenital/ chromosomal abnormalities.
- •Hemodynamic instability.
结局指标
主要结局
Incidence of late onset neonatal sepsis among VLBW neonates in neonatal intensive care unit in both the groups.
时间窗: Episodes late onset neonatal sepsis will be assessed in a continuum and compared among both the groups whenever the baby gets discharged.
次要结局
- Incidence of hypothermia in both the groups.(Every 10 minutes till temperature normalizes.)
- Rate of weight gain in both the groups.
- Physiological and behavioral responses to daily sponging.(1 minute after intervention.)
- Rise in salivary cortisol levels in daily sponging group.(20 minutes after intervention on day 3 of life.)
- Composite incidence of mortality or sepsis.(At discharge.)
研究者
Dr Arti Maria
ABVIMS and Dr. RML Hospital New Delhi
研究点 (1)
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