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Anxiety Clinical Trial

— CTREG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03481452
• Other study ID #: XJTU-PRENATALSTRESS-001
• Secondary ID: XCH-PRENATALSTRE
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2017
• Last updated: April 2, 2018
• Start date: July 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Hui Li, PhD, MD
• Phone: +86 18991232133
• Email: huili[@]mail.xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Behavior

Intervention

Behavioral:
• psychotherapy
NBO is an infant-focused, family relationship-based intervention measure, which aims to exhibit to parents infants' surprised ability, understand infants' strength and aspects needed to be improved, strength parents' parenting confidence, and promote sound development of infant-mother relationship.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Xi'an Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety	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.	up to 2 months