Socio-Emotional Development in Preterm Infants
1 other identifier
observational
100
1 country
1
Brief Summary
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:
- 1.understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development,
- 2.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,
- 3.examine the role of social support in buffering stress in mothers of preterm infants, and
- 4.evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 29, 2010
January 1, 2010
11 months
June 8, 2009
January 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quality of mother-infant interaction
term age and 12 months of corrected age
Secondary Outcomes (1)
maternal parenting efficacy
term age and 12 months of corrected age
Study Arms (1)
Preterm infants
birth weight\<1500 grams and gestational age\<30 weeks
Eligibility Criteria
Infants born prematurely with no significant congenital problems (e.g., cleft palate, cardiac malformations) and their mothers ages 18 to 40.
You may qualify if:
- preterm infants
You may not qualify if:
- significant congenital problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- University of Georgiacollaborator
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Hui-Chin Hsu, Ph.D.
University of Georgia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
January 29, 2010
Record last verified: 2010-01