Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03151122
Recruitment Status : Not yet recruiting
First Posted : May 12, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Jun Zhang, 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.


Condition or disease Intervention/treatment Phase
Preterm Infant Behavioral: Nurse-led Continuous Support Procedure: routine follow-up care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: continuous care group
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.
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.


Active Comparator: routine care group
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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maternal psychological well-being [ Time Frame: 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.

  2. Parental self-efficacy assessed by the Parenting Ladder Scale [ Time Frame: assess when infants reach 3 month of corrected age ]
    The Parenting Ladder Scale will be used to determine the mothers/fathers' parental self-efficacy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   28 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151122


Contacts
Layout table for location contacts
Contact: Jun Zhang, PhD 86-18507118605 catherinezhang2010@126.com
Contact: Chuan-Hua Yu, PhD 8627-68759710 00030045@whu.edu.cn

Sponsors and Collaborators
Wuhan University
Investigators
Layout table for investigator information
Study Chair: Chuan-Hua Yu Wuhan University School of Health

Layout table for additonal information
Responsible Party: Jun Zhang, Associate Professor, Wuhan University
ClinicalTrials.gov Identifier: NCT03151122     History of Changes
Other Study ID Numbers: 2017-04
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications