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

Not Applicable

• Conditions: Preterm Infant
• Interventions: Behavioral: Nurse-led Continuous Support; Procedure: routine follow-up care

• Registration Number: NCT03151122
• Lead Sponsor: Wuhan University

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.

Study Timeline

• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20
• Study Start: 2020-08-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous care group	Nurse-led Continuous Support	continuous care group (CCG): This is the experimental group where continuous care supported would be offered by the nurse coordinated integrative health care team. which is, parents in this group receive support during infant hospitalization. The support covers both hospitalization phase and after-discharge phase. In-hospital support include educational support and promoting mother-infant attachment. Nurses will be responsible for home visits after infant discharge.
routine care group	routine follow-up care	Routine Care Group (RCG): This is the comparison group of preterm infants. the routine care interventions generally include telephone reminding about follow-up care of the infants and hotline for parents to call when needed.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Maternal psychological well-being	assess 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 Scale	assess when infants reach 3 month of corrected age	The Parenting Ladder Scale will be used to determine the mothers/fathers' parental self-efficacy.