Very Low Birthweight Clinical Trial
Official title:
Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
| Verified date | December 2013 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | October 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 4 Years |
| Eligibility |
Inclusion Criteria for siblings: - Siblings of very low birth weight or healthy, full-term infants - age 4 years old or younger - siblings and infants must live with the mother Inclusion Criteria for mothers: - no previous or current diagnosis of major psychological disorder (including bipolar disorder, psychosis, or active substance abuse) - age 18 years or older - English speaking, - living within 1 hour's travel distance from Duke University, for feasibility. - Mothers at-risk for preterm birth who meet all other eligibility criteria Exclusion Criteria: Mother/sibling pairs of infants who: - have congenital neurological problems (congenital hydrocephalus or microcephaly), - are symptomatic from substance exposure, - are hospitalized longer than 1 month after term, or - are technology dependent. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Wake Medical Center | Raleigh | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | National Institute of Nursing Research (NINR) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants | 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. | baseline, one month, six months | No |
| Primary | Differences in mother-sibling interaction between two groups | 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. | one month and six months | No |
| Primary | Differences in internalizing and externalizing behaviors between two groups | 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. | one month and six months | No |
| Secondary | Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups | 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. | one month and six months | No |
| Secondary | Change in mother-sibling interactions between groups | 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. | one month and six months | No |