Back to resultsThe Setting and Effect Evaluation of QT in NICU
Primary Purpose
Very Low Birth Weight Infant
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Quiet time care
Sponsored by
About this trial
This is an interventional supportive care trial for Very Low Birth Weight Infant focused on measuring Quiet Time, Weight
Eligibility Criteria
Inclusion Criteria:
- Birth weight <1500g;
- Admit within 24 hours of birth;
- The guardian signs the informed consent.
Exclusion Criteria:
- Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
- Newborn who do not achieve discharge or death at the end of the study period.
Sites / Locations
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Quiet time care
Routine nursing care
Arm Description
Reduce noise and centralize medical or nursing operations in the NICU
Perform routine nursing care for the VLBWIs in the NICU
Outcomes
Primary Outcome Measures
Mean weekly gain in weight of VLBWIs
The average weekly gain in weight of VLBWIs in the intervention group minus the average weekly gain in weight of VLBWIs in the control group
Secondary Outcome Measures
Full Information
NCT ID
NCT05192668
First Posted
December 27, 2021
Last Updated
January 13, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05192668
Brief Title
The Setting and Effect Evaluation of QT in NICU
Official Title
The Setting and Effect Evaluation of Quiet Time in Neonatal Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In order to create a better environment for growth and development for very low birth weight infants(VLBWIs), investigators introduce quiet time, which is an intervention method that reduces environmental noise in the ward and centralizes medical and nursing operations. By analyzing the weight gain of VLBWIs in the intervention group and the control group during hospitalization, the effect of setting a quiet time in the NICU on improving the growth and development of VLBWIs is evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant
Keywords
Quiet Time, Weight
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quiet time care
Arm Type
Experimental
Arm Description
Reduce noise and centralize medical or nursing operations in the NICU
Arm Title
Routine nursing care
Arm Type
No Intervention
Arm Description
Perform routine nursing care for the VLBWIs in the NICU
Intervention Type
Other
Intervention Name(s)
Quiet time care
Intervention Description
This study is a non-self before and after control study. The data of VLBWIs in the control group is collected in the early stage, and the quiet time intervention is carried out in the later period, and the data of VLBWIs in the intervention group is collected
Primary Outcome Measure Information:
Title
Mean weekly gain in weight of VLBWIs
Description
The average weekly gain in weight of VLBWIs in the intervention group minus the average weekly gain in weight of VLBWIs in the control group
Time Frame
From the day the VLBWI admitted to the day VLBWI discharged, about two months.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birth weight <1500g;
Admit within 24 hours of birth;
The guardian signs the informed consent.
Exclusion Criteria:
Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
Newborn who do not achieve discharge or death at the end of the study period.
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
12. IPD Sharing Statement
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The Setting and Effect Evaluation of QT in NICU
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