NCT00917475

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. 1.understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development,
  2. 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. 3.examine the role of social support in buffering stress in mothers of preterm infants, and
  4. 4.evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 29, 2010

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

June 8, 2009

Last Update Submit

January 27, 2010

Conditions

Keywords

preterm infants

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

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • preterm infants

You may not qualify if:

  • significant congenital problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Study Officials

  • Hui-Chin Hsu, Ph.D.

    University of Georgia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suh-Fang Jeng, Ph.D.

CONTACT

Hui-Chin Hsu, Ph.D.

CONTACT

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

Locations