Clinical trial NCT00917475: Socio-Emotional Development in Preterm Infants
Official title: Socio-Emotional Development in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Infants
Keywords: preterm infants
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: University of Georgia
First posted: 2009-06-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* preterm infants

Exclusion Criteria:

* significant congenital problems

Primary outcomes:
measure: quality of mother-infant interaction
timeFrame: term age and 12 months of corrected age
Secondary outcomes:
measure: maternal parenting efficacy
timeFrame: term age and 12 months of corrected age
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: University of Georgia
name: Hui-Chin Hsu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: