Premature Birth Clinical Trial
Official title:
Improving Outcomes of LBW Premature Infants and Parents
Verified date | April 2009 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center Neonatal Intensive Care Unit | Rochester | New York |
United States | Crouse Hospital | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute of Nursing Research (NINR) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measures of emotional coping (mother/father/SO): State Anxiety Inventory: Phase I through VII Interventions and Observations (with exception of Phase II Observation) | |||
Primary | Beck Depression Inventory II: Phase I through VII Interventions and Observations (with exception of Phase II Observation) | |||
Primary | Parental stress related to NICU: Phase II (Intervention), Post hospital stress: Phase V, VI and VII (Intervention) | |||
Primary | Infant/child outcomes: Infant cognitive development assessment: 6, 12, 24 months corrected age (Observation), Child behavior questionnaire: Phase VII (Observation) | |||
Primary | Functional coping (mother/father/SO): Quality of parenting in the NICU: Phase II (Observation) | |||
Primary | Quality of parenting at home: Phase VI (Observation), Parental problem solving: Phase V (Intervention and Observation) | |||
Primary | Perception of child vulnerability: Phase VI and VII (Observation) | |||
Primary | Parental/SO beliefs (Proposed Mediator): Parental Beliefs Scale questionnaire: Phase II and III (Intervention) | |||
Secondary | Infant temperament (Proposed Moderator): Infant Temperament Questionnaires: Phase V, VI, VII (Intervention) | |||
Secondary | Cost outcomes (direct and indirect health care costs): Resource Utilization Questionnaire: 6, 12, 24 months corrected age (Observations) |
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