- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917475
Socio-Emotional Development in Preterm Infants
With advances in medicine and medical technology, premature infants born as early as 24 weeks of gestation and with birth weight less than 1000 grams are surviving today. Preterms are born with immature biological systems. Given their biological vulnerabilities, preterm infants are at risk for a variety of health and developmental problems.
As a group, preterms show developmental delays in physical growth, motor skills, attention, social communicative skills, intelligence, language, academic performance, and later behavior problems. Furthermore, research indicates that preterms are difficult social partners for their parents.
Despite biological insults and relational difficulties, research also shows that the development of premature infants appears to be facilitated by sensitive and responsive parenting. Little attention, however, has been paid to understand the social risks faced by preterm infants.
The proposed research, therefore, is designed to:
- understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development,
- explore the role of maternal social support, sociopsychological stress, and perception of infant vulnerability in the socioemotional development of preterm infants varying in biological risk,
- examine the role of social support in buffering stress in mothers of preterm infants, and
- evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development.
This study will include preterm infants recruited from the National Taiwan University Hospital at term and 12 months of corrected age. Infants will be examined for physical growth, neurobehavioral development, and mother and infant interaction at term. The growth measures including weight, height and head circumference will be assessed. Interaction between mother and infant will be investigated by observing the interaction between infants and their mothers in feeding and skin to skin contact conditions. Mothers' psychosocial stress and social support will be obtained via questionnaires.
It is expected that preterm infants' physical growth and neurobehavioral development as well as mothers' psychosocial stress and social support are associated with the quality of mother-infant interaction.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Suh-Fang Jeng, Ph.D.
- Phone Number: (02)33668132
- Email: jeng@ntu.edu.tw
Study Contact Backup
- Name: Hui-Chin Hsu, Ph.D.
- Phone Number: (706) 542-2636
- Email: hchin@uga.edu
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Suh-Fang Jeng, Ph.D.
- Phone Number: (02)33668132
- Email: jeng@ntu.edu.tw
-
Sub-Investigator:
- Hui-Chin Hsu, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- preterm infants
Exclusion Criteria:
- significant congenital problems
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Preterm infants
birth weight<1500 grams and gestational age<30 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of mother-infant interaction
Time Frame: term age and 12 months of corrected age
|
term age and 12 months of corrected age
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maternal parenting efficacy
Time Frame: term age and 12 months of corrected age
|
term age and 12 months of corrected age
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hui-Chin Hsu, Ph.D., University of Georgia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200904054R
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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