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Socio-Emotional Development in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00917475
Recruitment Status : Unknown
Verified January 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2009
Last Update Posted : January 29, 2010
University of Georgia
Information provided by:
National Taiwan University Hospital

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.

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 or disease
Preterm Infants

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Socio-Emotional Development in Preterm Infants
Study Start Date : January 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Preterm infants
birth weight<1500 grams and gestational age<30 weeks

Primary Outcome Measures :
  1. quality of mother-infant interaction [ Time Frame: term age and 12 months of corrected age ]

Secondary Outcome Measures :
  1. maternal parenting efficacy [ Time Frame: term age and 12 months of corrected age ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • preterm infants

Exclusion Criteria:

  • significant congenital problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00917475

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Contact: Suh-Fang Jeng, Ph.D. (02)33668132
Contact: Hui-Chin Hsu, Ph.D. (706) 542-2636

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Suh-Fang Jeng, Ph.D.    (02)33668132   
Sub-Investigator: Hui-Chin Hsu, Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
University of Georgia
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Principal Investigator: Hui-Chin Hsu, Ph.D. University of Georgia

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Responsible Party: Dr. Suh-Fang Jeng, School and Graduate Institute of Physical Therapy, National Taiwan University Identifier: NCT00917475     History of Changes
Other Study ID Numbers: 200904054R
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010

Keywords provided by National Taiwan University Hospital:
preterm infants

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications