Clinical trial NCT03481452: Tutorial of Clinical Trial Registration
Official title: NBO Ameliorates Disorders of Regulation of States in Little Infants From Perinatal Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior
Anxiety
Keywords: anxiety
regulation of states
NBO
HAMA
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xian Children's Hospital
First posted: 2018-03-29
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Hui Li, PhD, MD
role: STUDY_CHAIR
References: