- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481452
Tutorial of Clinical Trial Registration (CTREG)
April 2, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University
NBO Ameliorates Disorders of Regulation of States in Little Infants From Perinatal Anxiety
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui Li, PhD, MD
- Phone Number: +86 18991232133
- Email: huili@mail.xjtu.edu.cn
Study Contact Backup
- Name: zhongliang Zhu, PhD
- Phone Number: +86 13991289992
- Email: zlzhu@mail.xjtu.edu.cn
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- First Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- Hui Li, PhD, MD
- Phone Number: +86 18991232133
- Email: huili@mail.xjtu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: psychotherapy intervention group
NBO behavioral intervention would be used to improve mother-infant dyad interaction and infants' disorders of regulation of states.
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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.
Other Names:
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No Intervention: control group
No behavioral intervention would be used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety
Time Frame: up to 2 months
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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.
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up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Hui Li, PhD, MD, First Affiliated Hospital Xi'an Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2018
Primary Completion (Anticipated)
June 30, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
November 30, 2017
First Submitted That Met QC Criteria
March 27, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
April 3, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJTU-PRENATALSTRESS-001
- XCH-PRENATALSTRESS-001 (Other Identifier: Xi'an Children's Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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