Effect of Recorded Maternal Voice on Quantitative EEG (qEEG) as a Marker for Developmental Risk in the Preterm Newborn
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- qEEG change: within
研究概览
简要总结
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.
详细描述
This will be a randomized placebo-controlled clinical trial. Infants consented to participate will be randomized into the intervention arm or non-intervention arm by sealed unmarked envelope.
All consented participants will have an initial EEG of 60-90 minutes duration, performed at 32 5/7 - 32 6/7 weeks (and after 72 hours of life).
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), eligible subjects will proceed with randomized intervention or placebo for a 2-week (14 day) intervention period.
All infants will receive a 2nd EEG of 30-60 minutes duration, performed between 35 0/7 - 35 6/7 weeks corrected gestational age, following completion of either the intervention or non-intervention arm (with the goal of the 2nd EEG occurring within 48 hours of infants having completed the intervention vs. non-intervention arm).
EEG technician and all persons reviewing, pruning and analyzing data from the qEEG will be blinded to whether the infant was in the intervention or the non-intervention arm.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
NICU Investigator will provide the intervention versus placebo, with subject identification unlinked to randomization status. EEG reader, qEEG pruner and qEEG analyst will remain blinded to subject allocation until all data is extracted from each subject's EEG and medical record. To further prevent bias, group assignment unidentified as to control versus intervention will be maintained until all statistical analysis is complete.
入排标准
- 年龄范围
- 28 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation)
- •Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English)
排除标准
- •Infant with Critical Congenital Cardiac Disease
- •Infant with Chromosomal anomaly or Inborn Error of Metabolism
- •Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality
- •Infant receiving antiepileptic or sedation medications prior to EEG
- •Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age
- •Mother not available to provide voice recording in English
- •Unable to obtain consent from mother due to maternal health issues following delivery (such as mother requiring intubation or sedation following delivery
- •Mothers who are prisoners (as the study team would like to have continuing communication during the study period as needed)
- •Mothers who are <18 years of age will not be approached for consent
- •Any mother that is not able to consent due to having a legal representative will not be approached for consent
- •Any infant that is planned to be placed for adoption, is in foster care or is a ward of the state
研究组 & 干预措施
Placebo
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the non-intervention arm will be played a blank recording of approximately 60 minutes duration, once every 24 hours for a 2-week (14 day) period.
干预措施: Placebo Recording (Behavioral)
Recorded Voice Exposure
Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), infants randomized to the intervention arm will be played a recording of their mother's voice with approximately 60 minutes of scripted content, once per 24 hours for a 2-week (14 day) intervention period. (Mothers will be recorded reading a children's book and the recording will be looped to create the 60 minutes of content).
干预措施: Recorded Maternal Voice (Behavioral)
结局指标
主要结局
qEEG change: within
时间窗: 2 weeks
Change in relative spectral power, within group, of alpha (8-13 Hz) and beta (14-20 Hz) band
qEEG change: between
时间窗: 2 weeks
Difference in relative spectral power, between groups, of alpha (8-13 Hz) and beta (14-20 Hz) band, at baseline and post-treatment
次要结局
- Time to hospital discharge (between groups)(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
- Feeding(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
- NEC/Sepsis(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
- Duration of O2 support(Approximately 7-10 weeks, at NICU discharge date which typically occures around post-conceptional age 39-42 weeks.)
研究者
Aaron Cardon
Assistant Professor of Neurology
University of New Mexico