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临床试验/NCT02970994
NCT02970994已完成不适用

Linear Growth and Neurobehavioural Outcome in Preterm Neonates (<34 Weeks) at 37 Weeks and 40 Weeks of Corrected Gestational Age : a Prospective Observational Study

Lady Hardinge Medical College0 个研究点目标入组 70 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
Association of linear growth on neurobehavioural outcome in preterm neonates

研究概览

简要总结

This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.

详细描述

Growth of the preterm infant has historically been defined as weight gain over time. As weight gain and nutrition have been more extensively studied and their relationships with neurodevelopmental outcomes have been established, other growth parameters and their relationships to outcome need to be assessed.

Large multicenteric studies have demonstrated that poor postnatal weight gain has a negative effect on neurodevelopment . However, the neurodevelopmental consequences of linear stunting in this population were not assessed .Understanding this relationship is important because organ growth and differentiation are more closely linked to lean body mass and thus linear growth than to weight gain or fat mass alone. Moreover, weight gain and linear growth are not always tightly linked and may be influenced by both nutritional and non nutritional factors.

Linear growth represents lean body mass and protein accretion and also indexes organ growth and development, including the brain. American Academy of Pediatrics (AAP) recommends that preterm infants should grow similar to the fetus,but this guideline has been mostly applied to weight gain. As already described, the ideal weight gain to optimize neurodevelopmental outcomes has been studied extensively. However, ideal linear growth has yet to be defined. Intrauterine linear-growth velocity is approximately 1 cm/wk,and therefore is the goal that most neonatologists currently follow.Given the increasing evidence that linear-growth suppression is associated with poorer cognitive outcomes,length may now be an important anthropometric biomarker for later neurodevelopment. Research is needed to determine optimal goals of linear growth for preterm infants so as to optimize later growth and neurodevelopmental outcomes.

Recently the role of neurobehaviour has evaluated as early as at 37-40 weeks of CGA and is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment .Neurobehavioural assessment by tools like NAPI have been shown to correlate with BSID score at 18 months of corrected gestational age in preterm neonates.This has tremendous implications in terms of initiating an early rehabilitation /stimulation program for these neonates..

There is insufficient data on Correlation of linear growth and neurological outcome in preterm VLBW babies in India.With majority of VLBW neonates in India being SGA this assumes critical significance as growth faltering is reported to continue as late as 24 months postnatally.The linkage of linear growth faltering and poor neurodevelopmental outcome needs to be detected early in the India population and corrective strategies need to be instituted

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 40 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants ( Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission )
  • Parental Consent

排除标准

  • Major congenital malformation
  • Haemodynamic instability
  • Birth asphyxia(Apgar score of less than 7 at 1 minute of age)
  • Multiple gestation.
  • Meningitis
  • Hypoglycemia at admission

结局指标

主要结局

Association of linear growth on neurobehavioural outcome in preterm neonates

时间窗: 18 months

All preterm neonates born in LHMC who meet the inclusion criteria will be included in the study with in 48 hours of admission .Demographic data, maternal history, labour details and neonatal details will be recorded in the proforma. Length will be measured using a flexible tape measuring tape and a standard infant length board to the nearest 0.1 cm . Length will be measured at time of enrolment,at time of discharge,at 37 weeks and 40 weeks of corrected gestational age.Standardized Z-scores will be calculated for the length and using reference data which included Fenton curves at birth and hospital discharge. Neonates will be evaluated by NAPI score at 37 weeks and 40 weeks of corrected gestational age for neurobehavioural assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

DR. VIKRAM DATTA

Professor

Lady Hardinge Medical College

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