The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants
The Effect of Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants and Psychological Well-being of the Parents: A Randomized Controlled Trial
1 other identifier
interventional
140
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMay 20, 2020
May 1, 2020
4 months
May 5, 2017
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Maternal psychological well-being
assess when infants reach 1 month of corrected age.
Parental self-efficacy assessed by the Parenting Ladder Scale
assess when infants reach 3 month of corrected age
Study Arms (2)
continuous care group
EXPERIMENTALcontinuous 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
ACTIVE COMPARATORRoutine 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- infants with severe perinatal brain injury;
- infant with congenital anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuhan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chuan-Hua Yu
Wuhan University School of Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 12, 2017
Study Start
August 1, 2020
Primary Completion
December 1, 2020
Study Completion
April 1, 2021
Last Updated
May 20, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share