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临床试验/NCT03481452
NCT03481452Unknown不适用

NBO Ameliorates Disorders of Regulation of States in Little Infants From Perinatal Anxiety

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety

研究概览

简要总结

The present study aimed to determine whether infants disorders of regulation of states are associated with perinatal anxiety, and further to explore the efficacy of the behavioral intervention in enhancing positive interactions between mothers and their infants and thus ameliorating infants' disorders of regulation of states.

详细描述

The subjects were recruited from the hospitalized pregnant women waiting for delivery from the department of gynecology and obstetrics of the first affiliated hospital of Xi'an Jiaotong university. A total of 200 perinatal anxiety women were divided to two group(behavioral intervention group and control group) according to mental health assessment. Inclusion criteria were applied: 1. mother aged 18-40 years; 2. First-time mother, full-term and singleton pregnancy; 3.the Hamilton Anxiety Scale(HAMA) score ≥14; 4.birth with no intrapartum complications; and 5. Apgar score > 8 at the first, fifth, and tenth minutes after birth. Exclusion criteria were as follows: any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke,atrial fibrillation, peripheral arterial disease, and other severe diseases.Preterm infants (< 37 weeks gestation) and multiple births were excluded from the current analysis. All the subjects completed the infants behavior and regulation of states assessment by the NBAS and were followed to 8 weeks postpartum. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. 2 ml peripheral blood was collected in the pregnant woman before delivery and in the newborns within 3 days postpartum.The serum fraction was removed after centrifugation and stored at -20°C. Levels of serum cortisol in mothers and newborns were determined using Chemiluminescence analysis (CLIA) and a radio immunoassay. All sample analyses were performed by the first affiliated hospital of Xi'an Jiaotong university chemistry laboratory. Laboratory personnel were blinded to mother and infant outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
— 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • mother aged 18-40 years;
  • first-time mother, full-term and singleton pregnancy;
  • the Hamilton Anxiety Scale(HAMA) score ≥14;
  • the birth with no intrapartum complications;
  • Apgar score > 8 at the first, fifth, and tenth minutes after birth.

排除标准

  • any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke, atrial fibrillation, peripheral arterial disease, and other severe diseases;
  • preterm infants (< 37 weeks gestation);
  • multiple births;
  • infants with congenital anomalies, signs of illness, or high-risk factors.

结局指标

主要结局

NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety

时间窗: up to 2 months

The Hamilton Anxiety Scale(HAMA) was used to assess mothers anxiety state and whose score ≥14 were included. Meanwhile, Neonatal Behavioral Assessment Scale (NBAS) was used to assess infants neurobehavioral development and regulation of states from birth to 2 months. Regulation of states in the NBAS including four parts: cuddliness、consolability 、self-quieting and hand-to-mouth. Every part scores from 1 to 9, and the 1 represents worst and 9 for best. Higher scores of NBAS is associated with better regulation of states. Newborn Behavioral Observations (NBO) would be used to improve mother-infant dyad interaction and ameliorates infants disorders of regulation of states. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. Mother-newborn pairs serum would be collected to measure cortisol.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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