The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants
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|ClinicalTrials.gov Identifier: NCT03151122|
Recruitment Status : Not yet recruiting
First Posted : May 12, 2017
Last Update Posted : May 16, 2017
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|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Jun Zhang, PhDemail@example.com|
|Contact: Chuan-Hua Yu, PhDfirstname.lastname@example.org|
|Study Chair:||Chuan-Hua Yu||Wuhan University School of Health|