Educational/Behavioral Intervention Program for Parents of Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120614
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : April 8, 2009
National Institute of Nursing Research (NINR)
Information provided by:
University of Rochester

Brief Summary:

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 or disease Intervention/treatment Phase
Premature Birth Behavioral: Premature infant behavior and development information Behavioral: Parental activities to support premature infant information Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Improving Outcomes of LBW Premature Infants and Parents
Study Start Date : September 2001
Study Completion Date : June 2007

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120614

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
National Institute of Nursing Research (NINR)
Principal Investigator: Bernadette Melnyk, PhD, RNC Arizona State University/University of Rochester