Educational/Behavioral Intervention Program for Parents of Premature Infants - Full Text View

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:

MedlinePlus related topics: Anxiety Depression Parenting

U.S. FDA Resources

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

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

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Bernadette Melnyk, PhD, RNC

Arizona State University/University of Rochester

More Information

Publications:

Melnyk BM, Alpert-Gillis L, Feinstein NF, Fairbanks E, Schultz-Czarniak J, Hust D, Sherman L, LeMoine C, Moldenhauer Z, Small L, Bender N, Sinkin RA. Improving cognitive development of low-birth-weight premature infants with the COPE program: a pilot study of the benefit of early NICU intervention with mothers. Res Nurs Health. 2001 Oct;24(5):373-89.

Melnyk BM, Alpert-Gillis L, Feinstein NF, Crean HF, Johnson J, Fairbanks E, Small L, Rubenstein J, Slota M, Corbo-Richert B. Creating opportunities for parent empowerment: program effects on the mental health/coping outcomes of critically ill young children and their mothers. Pediatrics. 2004 Jun;113(6):e597-607.

Melnyk BM, Feinstein NF, Fairbanks E. Effectiveness of informational/behavioral interventions with parents of low birth weight (LBW) premature infants: an evidence base to guide clinical practice. Pediatr Nurs. 2002 Sep-Oct;28(5):511-6. No abstract available.

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 June 17, 2013