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

Duke University

Status: Completed

Conditions: Very Low Birthweight

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01385254

1R03NR011196-01A1 (U.S. NIH Grant/Contract)

Pro00019788

Details and patient eligibility

About

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.

Full description

The proposed 2-year study will use a longitudinal, comparative, mixed method design to explore the impact of a Very Low Birth Weight (VLBW) (≤33 weeks gestational age) infant on mother-sibling interactions and sibling adjustment. A comparison group of full term infants (≥38 weeks gestational age) will be included to elucidate sibling adjustment problems that are typical to having a new baby in the home and sibling adjustment problems that are associated with the unique stress of having to care for a VLBW infant. Participants will be fifty mothers and siblings of VLBW infants and fifty mothers and siblings of full term infants. Data collection will take place within one week of infant discharge from the hospital (enrollment), and at 1 month and 6 months post infant discharge using self-report measures, qualitative interviews, and mother-sibling interaction observation. Variables of interest include mother's worry, anxiety, depression, and post-traumatic stress; mother-sibling interactions including uninvolvement, positive affect, negative affect, talk, looking and playing; internalizing and externalizing behaviors, sleep/somatic problems, and growth in siblings of VLBW and in siblings of the comparison group with full term infants. Mixed modeling and Ordinary Least Squares (OLS) regression modeling will be conducted to identify factors that make siblings vulnerable to psychological and emotional adjustment problems in response to having a VLBW infant in the home. There are no anticipated risks for the infant participants of the study aside from the small risk of violating confidentiality of infant participants and their mothers. No risks for siblings are anticipated aside from the small risk of violating confidentiality.

Enrollment: 300 patients

Sex: All

Ages: Under 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

300 participants in 2 patient groups

siblings and mothers of Very Low Birth Weight infants

Description:

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

Description:

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)