Parents' Voice and White Noises in Neonatal Intensive Care Unit: Efficacy Evaluation Against Noises' Damage - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Reduction of heart rate alteration
研究概览
简要总结
The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit.
The main question it aims to answer is:
• Could the combined use of white noises and maternal and/or paternal voices reduce the negative outcomes of continuous exposure to hospital noises on newborns hospitalized in a Neonatal Intensive Care Unit?
Participants in the intervention group will listen to a recorded track composed of white noises and voices of their parents who read a story or sing a lullaby from the day of enrollment until the day of discharge, for 4 hours per day.
Researchers will compare the intervention group with the control group (who will receive the usual care provided without any intervention on the noise level) to see if babies enrolled in the intervention group show fewer events of tachycardia, tachypnea, desaturation, apnoea, and language or hearing impairment.
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
- None
入排标准
- 年龄范围
- 31 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the NICU with gestational age at birth ≥ 31 weeks (as this is the age at which sound perception is ≥ 40 dB and there is predictable clinical stability to allow intervention delivery without excessive interruptions)
- •Patients admitted to the NICU who reach gestational age ≥ 31 weeks
- •Patients monitored with the following types of monitors: Masimo rainbow SET™ (Masimo); Infinity® Delta (Draeger); Infinity® Acute Care System (Draeger); Efficia CM (Philips).
排除标准
- •Patients with gestational age at birth < 31 weeks
- •Patients affected by meningitis or severe cerebral insults, congenital brain anomalies, congenital syndromes with suspected or known brain dysfunction
- •Patients diagnosed with hypoxic-ischemic encephalopathy
- •Patients with significant airway abnormalities resulting in altered breathing during sleep
- •Patients with terminal illnesses
- •Patients with congenital anomalies of the face, ears, skull, or brain
- •Patients with non-bacterial congenital infections
- •Patients with congenital hearing deficits
- •Patients whose parents or legal guardians refuse to participate in the study
- •Patients already enrolled in other clinical studies.
研究组 & 干预措施
Intervention Group
Those in the intervention group will receive the administration of white noises and maternal and/or paternal voice recording.
干预措施: White Noises and Maternal and/or Paternal voices (Behavioral)
Control Group
Those enrolled in the control group will receive standard care and will be subjected to the usual level of ambient noise.
结局指标
主要结局
Reduction of heart rate alteration
时间窗: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of heart rate alteration associated with noises \> 45 dB (nursing diagnosis: risk of tachycardia - HR \>180 bpm - correlated with environmental exposure to noises \> 45dB).
Reduction of oxygen saturation alteration
时间窗: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of oxygen saturation alteration associated with noises \> 45 dB (nursing diagnosis: risk of desaturation - SpO2 \<90% - correlated with environmental exposure to noises \> 45dB).
Reduction of respiratory rate alteration
时间窗: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of respiratory rate alteration associated with noises \> 45 dB (nursing diagnosis: risk of tachypnoea - RR \>60 breaths per minute - correlated with environmental exposure to noises \> 45dB).
Reduction of episodes of apnoea
时间窗: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of apnoea associated with noises \> 45 dB (nursing diagnosis: risk of apnoea - HR \<100 bpm and SpO2 \<90% - correlated with environmental exposure to noises \> 45dB).
次要结局
- Reduction in Language Development Alterations(From enrollment unitl 3 years of age)
- Reduction in Hearing Development Alterations(From enrollment unitl 3 months of age)
研究者
Silvia Rossi
Doctor in Methodology Research in Nursing
Istituto Giannina Gaslini