跳至主要内容
临床试验/CTRI/2018/12/016715
CTRI/2018/12/016715Other未知

Growth and nutritional biomarkers in preterm infants in NICU â?? a Multicentric Study in India - PTF

estle India Limited0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
Other
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • Stable Preterm AGA infants born between 28 to 34 weeks of gestational age who are on enteral feeding,
  • Singleton gestation

排除标准

  • On any other clinical study affecting nutritional management during the study period
  • Decision to not start minimum enteral feed within 48 hours of birth
  • Unable to obtain informed consent from parent (s) or legal guardian prior to the initiation of enteral feeding
  • Infants experiencing early onset sepsis (i.e. symptoms requiring antibiotic therapy and confirmed by a positive blood culture occurring before the 3rd day of life).
  • Presence of clinically significant congenital heart disease
  • Presence of any major congenital malformations, chromosomal abnormality or major gastro intestinal disease known to affect growth
  • Liver failure as detected by (if laboratory data is available) aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and direct bilirubin serum values 3-fold higher than reference range.
  • Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) determined using cranial ultrasonography, if it is performed.
  • Other serious disorders of cardiac/ respiratory/ endocrine/ hematological/ gastrointestinal/ other systems, or serious diseases requiring surgical intervention
  • Reasonable potential for early transfer to a non-study institution

研究者

发起方
estle India Limited

相似试验