Educational/Behavioral Intervention Program for Parents of Premature Infants

NCT00120614 | Completed

• 2 other identifiers: 069905RO1MR5077-5
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Birth

Keywords

Premature Infant; Premature Birth; Parenting Interventions; NICU Interventional studies; Parental coping; Low birthweight infant; Coping Behavior; Infant, Premature

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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)

Interventions

Premature infant behavior and development information BEHAVIORAL

Parental activities to support premature infant information BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parent/infant has positive drug testing
• Live outside of a 60 mile radius
• Had previous infants in a NICU
• Significant mental health history

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University of Rochester Medical Center Neonatal Intensive Care Unit

Rochester, New York, 14642, United States

Location

Crouse Hospital

Syracuse, New York, 13210, United States

Location

Related Publications (3)

• 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. doi: 10.1002/nur.1038.

  PMID: 11746067 BACKGROUND

• 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. doi: 10.1542/peds.113.6.e597.

  PMID: 15173543 BACKGROUND

• 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.

  PMID: 12424989 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Bernadette Melnyk, PhD, RNC

  Arizona State University/University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 18, 2005
• Study Start: September 1, 2001
• Study Completion: June 1, 2007
• Last Updated: April 8, 2009

Record last verified: 2009-04

Locations

US (2)