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

Primary Purpose

Preterm Infant

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nurse-led Continuous Support
routine follow-up care
Sponsored by
Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Infant

Eligibility Criteria

28 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    continuous care group

    routine care group

    Arm Description

    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 (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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Maternal psychological well-being
    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
    The Parenting Ladder Scale will be used to determine the mothers/fathers' parental self-efficacy.

    Full Information

    First Posted
    May 5, 2017
    Last Updated
    May 19, 2020
    Sponsor
    Wuhan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03151122
    Brief Title
    The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2020 (Anticipated)
    Study Completion Date
    April 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wuhan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Infant

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous care group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    routine care group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nurse-led Continuous Support
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    routine follow-up care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Infant neuro-development assessed by the Ages and Stages Questionnaire (ASQ)
    Description
    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.
    Time Frame
    infant neuro-development will be measured at 3 months of corrected age.
    Secondary Outcome Measure Information:
    Title
    Maternal psychological well-being
    Description
    Edinburgh postnatal depression scale (EPDS) will be used to assess psychological well-being of preterm mothers.
    Time Frame
    assess when infants reach 1 month of corrected age.
    Title
    Parental self-efficacy assessed by the Parenting Ladder Scale
    Description
    The Parenting Ladder Scale will be used to determine the mothers/fathers' parental self-efficacy.
    Time Frame
    assess when infants reach 3 month of corrected age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    36 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Zhang, PhD
    Phone
    86-18507118605
    Email
    catherinezhang2010@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chuan-Hua Yu, PhD
    Phone
    8627-68759710
    Email
    00030045@whu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chuan-Hua Yu
    Organizational Affiliation
    Wuhan University School of Health
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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