Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
|ClinicalTrials.gov Identifier: NCT01385254|
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : December 11, 2013
|Condition or disease|
|Very Low Birthweight|
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Observational Model:||Case Control|
|Official Title:||Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming|
|Study Start Date :||January 2010|
|Primary Completion Date :||May 2012|
|Study Completion Date :||October 2012|
siblings and mothers of Very Low Birth Weight infants
50 older siblings (closest in age) and mothers of very low birthweight (VLBW) infants, born at <33 weeks gestation and <1500 grams at birth
siblings and mothers of healthy infants
50 siblings (closest in age) and mothers of healthy, full-term infants (between 38-42 weeks gestation and lacking medical conditions that require a hospital stay past the mother's discharge date)
- Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants [ Time Frame: baseline, one month, six months ]Explore how the trajectories of maternal worry about the infant and sibling, anxiety, depression, post traumatic stress, concerns for and expectations of the sibling, and perceptions of sibling growth over the 6-month post discharge period differ between mothers of VLBW infants and mothers of fullterms.
- Differences in mother-sibling interaction between two groups [ Time Frame: one month and six months ]Explore differences in mother-sibling interactions, including involvement, positive/negative affect, talking, looking and playing, at 1 and 6 months after infant discharge between the two groups of siblings and mothers, using a coding schema to score videotaped interactions.
- Differences in internalizing and externalizing behaviors between two groups [ Time Frame: one month and six months ]Explore differences in internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems at 6-months post-infant discharge between siblings of VLBW infants and siblings of fullterms, using a coding schema to score videotaped interactions.
- Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups [ Time Frame: one month and six months ]Examine the effects of maternal worry, anxiety, depression, and post traumatic stress on group differences in mother-sibling interactions at 1 and 6 months after infant discharge.
- Change in mother-sibling interactions between groups [ Time Frame: one month and six months ]Examine the effects of changes in mother-sibling interactions from 1 to 6 months after infant discharge on group differences in siblings' internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385254
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Wake Medical Center|
|Raleigh, North Carolina, United States, 27610|
|Principal Investigator:||Julie A Thompson, PhD||Duke University School of Nursing|