The Effect of Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants and Psychological Well-being of the Parents: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 140
- Primary Endpoint
- Infant neuro-development assessed by the Ages and Stages Questionnaire (ASQ)
Study Overview
Brief Summary
The objective of the study is to establish a continuous nurse-led integrated support program and to exam its impact on preterm infant neurodevelopment.
Research hypotheses include:1. The continuous nurse-led integrated support will have significant impact on preterm infant neurodevelopment; 2.The support program will also have positive effect on parent psychological well-being.
Detailed Description
The objective of the study is to establish the continuous nurse-led integrated support program as well as exam its impact on neurodevelopmental health of preterm infants.
Research hypotheses:
- Compared to control group, the preterm infants in the interventional group will experience significantly better performance on neuromotor, cognitive and social-emotional function at corrected age of 3 month;
- In comparison with those receiving routine support, parents receiving nurse-led continuous support will have significantly higher parental self-efficacy and exhibited better psychological well-being;
- Maternal parenting self-efficacy will mediate the relationship between nurse-led support and preterm infant neurodevelopment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 28 Weeks to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants born between 28-36 weeks of gestation;
- •Parents residing in the same region for at least 5 years; .Parents agree to participate in the study.
Exclusion Criteria
- •infants with severe perinatal brain injury;
- •infant with congenital anomalies
Outcomes
Primary Outcomes
Infant neuro-development assessed by the Ages and Stages Questionnaire (ASQ)
Time Frame: infant neuro-development will be measured at 3 months of corrected age.
preterm infant will be assessed by the Ages and Stages Questionnaire (ASQ). The scale is used to help parent evaluate the development outcome of infants and young children by themselves.
Secondary Outcomes
- Maternal psychological well-being(assess when infants reach 1 month of corrected age.)
- Parental self-efficacy assessed by the Parenting Ladder Scale(assess when infants reach 3 month of corrected age)
Investigators
Jun Zhang
Associate Professor
Wuhan University