Early Behavioral Intervention for Preterm Infants

Description

The purpose of this study is to determine the effects of Family Nurture Intervention in preschool aged children between 2.5 and 4 years of age who were born prematurely and exhibit developmental deficits. The new approach is based on improving aspects of maternal nurturing behaviors as well as mother-child co-regulation, which are important to early development. Since young children with developmental deficits are often easily upset, mothers will be taught how to co-regulate with their child through comfort and calming interactions during 6 clinic visits. Assessments in the follow-up clinic will test the immediate and long-term effects of this new approach to the nurture of children who were born early and demonstrate developmental problems.

Study Start Date

February 2015

Estimated Completion Date

March 2018

Interventions

  • Behavioral: Family Nurture Intervention
  • Behavioral: Play and Nutrition Intervention

Specialties

  • Pediatrics: Neonatology
  • Family Medicine: Peds Family Medicine

MeSH Terms

  • Premature Birth

Study ID

Columbia University -- AAAO2957

Status

Unknown

Trial ID

NCT02379130

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

80

Sponsor

Columbia University

Inclusion Criteria

  • Child was born between 26 and 37 weeks gestational age
  • Infant is a singleton (matched between groups)
  • Mother is 18 years of age or older
  • Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent)
  • Child demonstrates developmental deficit (language, cognition, motor, emotion)

Exclusion Criteria

  • The child has severe congenital anomalies including chromosomal anomalies
  • The child has severe motor or physical disability
  • Mother currently presents with psychosis or is currently taking antipsychotic medication
  • Status of enrolled subject changes and subject no longer falls in inclusion criteria
  • Mother and/or infant has a medical condition that precludes intervention components
  • Mother and/or infant has a contagion that endangers other participants in the study

Gender

Both

Ages

30 Months to 4 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
51 Audubon Avenue Suite 100 - New York City, New York 44.8 miles Robert J Ludwig BA 212-342-4400 rjl2128@columbia.edu

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