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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03151122
• Other study ID #: 2017-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2020
• Source: Wuhan University
• Contact: Jun Zhang, PhD
• Phone: 86-18507118605
• Email: catherinezhang2010[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Behavioral:
• Nurse-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.

Procedure:
• routine 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant neuro-development assessed by the Ages and Stages Questionnaire (ASQ)	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.	infant neuro-development will be measured at 3 months of corrected age.
Secondary	Maternal psychological well-being	Edinburgh postnatal depression scale (EPDS) will be used to assess psychological well-being of preterm mothers.	assess when infants reach 1 month of corrected age.
Secondary	Parental self-efficacy assessed by the Parenting Ladder Scale	The Parenting Ladder Scale will be used to determine the mothers/fathers' parental self-efficacy.	assess when infants reach 3 month of corrected age