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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Very Low Birthweight

Keywords

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very low birthweight premature sibling adjustment preterm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

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.

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie A Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Medical Center

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1R03NR011196-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00019788

Identifier Type: -

Identifier Source: org_study_id