PACTR202110642756045招募中1 期
The Baby Book Project.Can nursery rhyme reading by mothers, during the hospital stay, support neurodevelopment and maternal-infant interaction in premature infants?
Harry Crossley foundation0 个研究点目标入组 320 人开始时间: 2021年10月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 Day(s) 至 1 Month(s)(—)
- 性别
- All
入选标准
- •Premature infants born at or before 32 weeks gestational age (but at least 26weeks) with birth weight 1250 grams or less, but more than 750g.
- •Infants have to be inborn at Tygerberg Hospital or admitted within the first two weeks of life
- •Infants have to be clinically stable as deemed by attending consultant.
- •Maternal native language has to be English, Afrikaans or isiXhosa.
- •Mother has to be literate.
- •Permanent address in the Western Cape area.
排除标准
- •Infants less than 750g and less than 26 weeks
- •Prenatally diagnosed brain lesions.
- •Evidence of perinatal asphyxia and neonatal asphyxia.
- •Known alcohol or methamphetamine abuse in pregnancy.
- •Maternal Illiteracy.
- •SGA: weight less than the tenth percentile on Fenton growth chart.
- •Grade 3 and 4- intraventricular haemorrhage IVH (Papille classification)
- •Cystic periventricular leucomalacia (PVL): Grade 4
- •Dilated lateral ventricular atria above 95th percentile.
- •Microcephaly: Head circumference less than the third percentile at birth (or more than two standard deviations below the mean on follow-up).
- •Significant congenital abnormalities, e.g. cardiac lesions that need surgical correction.
- •Surgical necrotising enterocolitis
- •Abnormal auditory brainstem response at discharge or follow-up.
- •Not able to speak English, Afrikaans or isiXhosa.
- •When more than three episodes of otitis media and middle ear fluid documented before 6-8 months post-term, the infant will be excluded.
研究者
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