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临床试验/NCT02840292
NCT02840292已完成不适用

Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年6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
100
试验地点
1
主要终点
Evaluation of neurobehavioral development

研究概览

简要总结

The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late preterm neonates' was done with an objective to determine whether low maternal hemoglobin (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age) correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken to improve their long term outcomes and to generate useful data on a previously well recognised but under researched entity.

详细描述

Prevalence of anemia in India is among the highest in the world. A high proportion of women in both industrialized and developing countries become anemic during pregnancy. The major concern about the adverse effects of anemia on pregnant women and their offsprings is the belief that this population is at a greater risk of perinatal mortality and morbidity. Apart from this, it is well known that anemia per se is associated with higher incidence of premature births and low birth weight babies. Infants with iron deficiency anemia have significantly lower motor and mental scores and decreased language capabilities and body balance-coordination skills. Such infants also have a decreased learning ability. Iron deficiency anemia during the developmental stage can lead to reduced myelination of the spinal cord, as well as a change in myelin composition; abnormalities in neurotransmitters' metabolism and alteration in brain energy metabolism. The Neurobehavioral Assessments of Preterm Infants (NAPI) is a research tool to monitor the developmental progress and differential maturity of preterm infants ranging between 32weeks and 37weeks (full term). This test is used to identify persistent lags in development, as a research tool to assess effects of interventions and to study individual differences and basic developmental questions. The reliability and clinical validity of this test has been thoroughly investigated and normative data has been established.

Objective - To evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm infants born to mothers with hemoglobin <11gm/dl; by a standardised scale - Neurobehavioral Assessment of Preterm Infants (NAPI).

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
34 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Late preterm infants born to mothers <35yrs of age and born between 34weeks to 36.6weeks of gestation as calculated by last menstrual period/1st trimester ultrasound
  • Clinically stable from respiratory, hemodynamic and metabolic point of view
  • After receiving full, free, voluntary, informed consent from parents/family members within 24 hours of delivery.

排除标准

  • Chorioamnionitis in pregnancy.
  • Congenital malformations (antenatally diagnosed or evident on clinical examination)
  • Neonates admitted to NICU
  • Neonates requiring ventilator support
  • Neonates with any neurological impairment (IVH etc)
  • Neonates undergoing surgery
  • Neonates with birth asphyxia
  • Neonates with birth trauma
  • Confirmed history of substance abuse in mother.

结局指标

主要结局

Evaluation of neurobehavioral development

时间窗: 2 months

The two sub domains of Neurobehavioral Assessment of Preterm Infants (NAPI) i.e. Motor Development and Vigor (MDV) and Alertness and Orientations (AO) were tested to evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm neonates

次要结局

  • Comparison of NAPI Score(1 month)

研究者

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

DR. VIKRAM DATTA

Professor,Department of Neonatology

Lady Hardinge Medical College

研究点 (1)

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