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The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants

The Effect of Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants and Psychological Well-being of the Parents: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03151122
Enrollment
140
Registered
2017-05-12
Start date
2020-08-01
Completion date
2021-04-01
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infant

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: 1. 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; 2. 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; 3. Maternal parenting self-efficacy will mediate the relationship between nurse-led support and preterm infant neurodevelopment.

Interventions

BEHAVIORALNurse-led Continuous Support

The Nurse-Led Continuous Support was provided by a integrative care team. In-hospital support included(1) Promoting early parental-infant interaction;(2) Instruct the mother and/or father to use sensory stimulation activities to promote infant neuro-development in the NICU;(3) Parental educational support. The integrative care team will teach infant care skills, prepare them for successful transition from hospital to home setting. After infant discharge support will consist of regular home visits by the nurses. Home visits will be offered every other week until children reaching 3 Months of corrected age.

PROCEDUREroutine follow-up care

after infant discharge, parents were usually called upon to remind the date and time of follow-up care with physicians in outpatient department. A contact number was also given to parents in case they have questions about follow-up care.

Sponsors

Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 36 Weeks
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

Design outcomes

Primary

MeasureTime frameDescription
Infant neuro-development assessed by the Ages and Stages Questionnaire (ASQ)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

MeasureTime frameDescription
Maternal psychological well-beingassess when infants reach 1 month of corrected age.Edinburgh postnatal depression scale (EPDS) will be used to assess psychological well-being of preterm mothers.
Parental self-efficacy assessed by the Parenting Ladder Scaleassess when infants reach 3 month of corrected ageThe Parenting Ladder Scale will be used to determine the mothers/fathers' parental self-efficacy.

Contacts

Primary ContactJun Zhang, PhD
catherinezhang2010@126.com86-18507118605
Backup ContactChuan-Hua Yu, PhD
00030045@whu.edu.cn8627-68759710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026