Preterm Infants: Light Effects on Health and Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Change in sleep development after discharge home
研究概览
简要总结
Preterm babies cared for in the intensive care nursery are exposed to amounts of light that are very different from the exposures to an unborn baby or the newborn term baby. Currently many nurseries try to protect premature babies from too much light. They may also try to create light conditions of day and night like many parent homes. Some studies have shown improvements in health and development of babies cared for in nurseries that try to change light for premature babies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants were < 7 days of age and were born at 28 weeks or < 28 weeks
排除标准
- •known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)
结局指标
主要结局
Change in sleep development after discharge home
时间窗: Every 5 months following hospital discharge up to 24 months PMA
Change in the development of sleep and wake bouts were evaluated following hospital discharge until the infant reached 24 months PMA
Mental Development
时间窗: 18 months PMA
Mental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development
时间窗: 18 months PMA
Psychomotor Development was measured using the Bayley Scales of Infant Development
Infant weight gain trajectory
时间窗: weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months
This measure was single blinded.
Change in sleep development during hospitalization
时间窗: Every three weeks up to 52 weeks PMA
Change in the developmental pattern of four sleep wake states (active, quiet, transition, awake) were evaluated during hospitalization.
次要结局
- Neurological development(18 months PMA)
- Length of Hospitalization in Days(At hospital discharge from 0 to 222 days)
- Severity of Retinopathy of Prematurity (ROP)(Up to 52 weeks)
- visual acuity(Measures at 12 months PMA)
- Brainstorm Auditory Evoked Potentials(6 months)
- Change in Retinopathy of Prematurity (ROP)(Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMA)