Educational/Behavioral Intervention Program for Parents of Premature Infants

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00120614
First received: July 7, 2005
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to determine whether beginning an enriched educational/behavioral program for parents of premature infants, very early in the Neonatal Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial results for both the parents and their infants.

The hospital phase of the program gives parents an understanding of what to expect in the NICU environment; physical characteristics and needs of their premature baby; and how and when to best support their infant's development during this time. The information given during the home phase of the program continues with information specific to the growth and development and the effective parenting of an infant/toddler who has been born prematurely.

It is believed that this information will help decrease parents' stress, anxiety and depression levels that can be related to giving birth to a premature infant. It is also expected that it will strengthen the mother's and father's ability to parent their premature child in a way that will help support their child's brain development and learning ability and to also decrease negative behaviors as the child grows.


Condition Intervention
Premature Birth
Behavioral: Premature infant behavior and development information
Behavioral: Parental activities to support premature infant information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Improving Outcomes of LBW Premature Infants and Parents

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Measures of emotional coping (mother/father/SO): State Anxiety Inventory: Phase I through VII Interventions and Observations (with exception of Phase II Observation)
  • Beck Depression Inventory II: Phase I through VII Interventions and Observations (with exception of Phase II Observation)
  • Parental stress related to NICU: Phase II (Intervention), Post hospital stress: Phase V, VI and VII (Intervention)
  • Infant/child outcomes: Infant cognitive development assessment: 6, 12, 24 months corrected age (Observation), Child behavior questionnaire: Phase VII (Observation)
  • Functional coping (mother/father/SO): Quality of parenting in the NICU: Phase II (Observation)
  • Quality of parenting at home: Phase VI (Observation), Parental problem solving: Phase V (Intervention and Observation)
  • Perception of child vulnerability: Phase VI and VII (Observation)
  • Parental/SO beliefs (Proposed Mediator): Parental Beliefs Scale questionnaire: Phase II and III (Intervention)

Secondary Outcome Measures:
  • Infant temperament (Proposed Moderator): Infant Temperament Questionnaires: Phase V, VI, VII (Intervention)
  • Cost outcomes (direct and indirect health care costs): Resource Utilization Questionnaire: 6, 12, 24 months corrected age (Observations)

Estimated Enrollment: 260
Study Start Date: September 2001
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Gestational age of 26 to 34 weeks inclusive
  • Birthweight of less than 2500 grams
  • Singleton birth
  • Anticipated survival
  • Not small for gestational age
  • No severe handicapping conditions
  • No Grade III or IV intraventricular hemorrhage
  • Speaks and reads English

Exclusion Criteria:

  • Parent/infant has positive drug testing
  • Live outside of a 60 mile radius
  • Had previous infants in a NICU
  • Significant mental health history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120614

Locations
United States, New York
University of Rochester Medical Center Neonatal Intensive Care Unit
Rochester, New York, United States, 14642
Crouse Hospital
Syracuse, New York, United States, 13210
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Bernadette Melnyk, PhD, RNC Arizona State University/University of Rochester
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00120614     History of Changes
Other Study ID Numbers: 06990, 5RO1MR5077-5
Study First Received: July 7, 2005
Last Updated: April 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Premature Infant
Premature Birth
Parenting Interventions
NICU Interventional studies
Parental coping
Low birthweight infant
Coping Behavior
Infant, Premature

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 22, 2014