Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

NCT01385254 | Completed DMC

• 2 other identifiers: Pro000197881R03NR011196-01A1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Very Low Birthweight

Keywords

very low birthweight; premature; sibling adjustment; preterm

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups

  one month and six months

• Change in mother-sibling interactions between groups

  one month and six months

Study Arms (2)

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)

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mothers who give birth at Duke University Medical Center, Durham Regional Hospital, or Wake Medical Center, and their siblings.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Julie A Thompson, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: June 30, 2011
• Study Start: January 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (2)