Socio-Emotional Development in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Georgia
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00917475
First received: June 8, 2009
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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.

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.


Condition
Preterm Infants

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Socio-Emotional Development in Preterm Infants

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • quality of mother-infant interaction [ Time Frame: term age and 12 months of corrected age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maternal parenting efficacy [ Time Frame: term age and 12 months of corrected age ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preterm infants
birth weight<1500 grams and gestational age<30 weeks

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants born prematurely with no significant congenital problems (e.g., cleft palate, cardiac malformations) and their mothers ages 18 to 40.

Criteria

Inclusion Criteria:

  • preterm infants

Exclusion Criteria:

  • significant congenital problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917475

Contacts
Contact: Suh-Fang Jeng, Ph.D. (02)33668132 jeng@ntu.edu.tw
Contact: Hui-Chin Hsu, Ph.D. (706) 542-2636 hchin@uga.edu

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Suh-Fang Jeng, Ph.D.    (02)33668132    jeng@ntu.edu.tw   
Sub-Investigator: Hui-Chin Hsu, Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
University of Georgia
Investigators
Principal Investigator: Hui-Chin Hsu, Ph.D. University of Georgia
  More Information

No publications provided

Responsible Party: Dr. Suh-Fang Jeng, School and Graduate Institute of Physical Therapy, National Taiwan University
ClinicalTrials.gov Identifier: NCT00917475     History of Changes
Other Study ID Numbers: 200904054R
Study First Received: June 8, 2009
Last Updated: January 27, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
preterm infants

ClinicalTrials.gov processed this record on August 19, 2014