Contrasting the neuro developmental trajectories in moderate to late preterm infants at birth and at term corrected age with their full term counterparts.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hammersmith Neonatal Neurological Examination
研究概览
简要总结
Preterm infants and full term infants will be purposefully selected from Sri
Ramakrishna Hospital ensuring they met the inclusion and exclusion criteria
Informed consents will be obtained from the parents after explaining about my research
study. Both PTI and FTI will be examined using HNNE scale within one week after
birth.
During the examination the newborns should be undressed and placed on a open bed or
cot in a room with warmer.The examination is done between two consecutive feeds to ensure the baby is calm and
comfortable.
Preterm infants will be reassessed when they reach their term corrected age. During a
follow-up or during vaccination. If not possible, home visits will be scheduled. All the
data’s will be recorded and statistically analyzed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.10 Month(s) 至 0.80 Month(s)（—）
- 性别
- All
入选标准
- •Gestational age: GROUP 1- moderate to late preterm (32-37 weeks) GROUP 2- full term infants (39-41 weeks) Birth weight above 1200 g.
- •APGAR score above
- •Parents willing to give consent.
排除标准
- •Clinically unwell.
- •Neonatal infections.
- •Congenital abnormality.
- •Chromosomal anomalies.
- •Birth injuries.
- •Significant bilirubinemia Intrauterine infection.
- •Inborn errors of metabolism.
- •Children born with: Birth asphyxia, Intracranial hemorrhage, Neonatal seizures, Neural tube defects, Brain malformations, Hypotonia, encephalopathy.
结局指标
主要结局
Hammersmith Neonatal Neurological Examination
时间窗: At birth and at term corrected age
次要结局
未报告次要终点
研究者
Shehanaz samsudeen
Sri Ramakrishna institute of paramedical sciences.