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临床试验/PACTR202110642756045
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

发起方
Harry Crossley foundation

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