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临床试验/NCT00166660
NCT00166660Unknown2 期

Preterm Fetal Growth Restriction and Developmental Care

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年7月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
30
试验地点
4
主要终点
Assessment of Preterm Infants' Behavior (APIB)

研究概览

简要总结

The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity).

详细描述

The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction (FGR). Incidence of FGR is estimated to be as high as 5% of the general obstetric population. Preterms with FGR are doubly jeopardized. Aside from much higher mortality rates they also show significantly increased morbidity rates, including significant learning disabilities and school failure (>50%). The intervention's underlying premise holds that it is far more effective to support the immature brain, which is compromised by FGR, to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred. The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Intervention in the NICU is considered more advantageous for the infant's later development than delay of intervention until after discharge home. The proposal maintains that the last trimester of gestation is a critical period for brain development, especially when compromised by FGR. In-NICU intervention at this critical brain development time is expected to reduce the infants' hypersensitivity and reactivity while in the NICU, and to lead to reduction of the high incidence of behavioral problems in infancy, which frequently foreshadows later behavioral and learning problems as well as school failure.

The study aims to test three related hypotheses:

  1. Individualized developmental NICU care and intervention will enhance FGR preterm infants' brain development both functionally and structurally.
  2. The in-NICU intervention will improve the parents' understanding of their infant's individuality and equip them to feel more competent as parents.
  3. The intervention itself, while individualized for each infant, will be quantifiable and reliably reproducible.

The study will:

  1. Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population (n=30) with documented intrauterine FGR and born between 28 and 33w gestational age.
  2. Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome).
  3. Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown (AGA) preterm infants born at comparable gestational ages, supported with the same intervention and measured in comparable ways.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
28 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Inborn at Brigham and Women's Hospital, Boston
  • Gestational age ≥28 and ≤33 weeks
  • Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity
  • Less than 5th percentile in birthweight and head circumference for gestational age

排除标准

  • Major chromosomal or congenital anomalies
  • Major congenital infections
  • Significant prenatal diagnosed focal brain lesions
  • Uncontrolled maternal illness
  • History of smoking, alcoholism, and use of illicit drugs
  • History of significant maternal deprivation, abuse, or malnutrition
  • No telephone access and/or insufficient English language facility

结局指标

主要结局

Assessment of Preterm Infants' Behavior (APIB)

时间窗: 2 weeks corrected age (2w CA)

Magnetic Resonance Imaging(MRI)

时间窗: 2 weeks Corrected Age (2w CA)

Quantified Electroencephalography (qEEG)

时间窗: 2 weeks Corrected Age (2w CA)

次要结局

  • Parent Stress Level(2 weeks Corrected Age (2w CA))

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (4)

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