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The Setting and Effect Evaluation of QT in NICU

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT05192668
Collaborator
(none)
124
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
9.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quiet time care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Setting and Effect Evaluation of Quiet Time in Neonatal Intensive Care Unit
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Quiet time care

Reduce noise and centralize medical or nursing operations in the NICU

Other: Quiet time care
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
No Intervention: Routine nursing care

Perform routine nursing care for the VLBWIs in the NICU

Outcome Measures

Primary Outcome Measures

  1. Mean weekly gain in weight of VLBWIs [From the day the VLBWI admitted to the day VLBWI discharged, about two months.]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Day
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Fudan University Shanghai Shanghai China 201102

Sponsors and Collaborators

  • Children's Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT05192668
Other Study ID Numbers:
  • [2021]296
First Posted:
Jan 14, 2022
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Children's Hospital of Fudan University
Quiet Time
Weight
Additional relevant MeSH terms:
Birth Weight

Study Results

No Results Posted as of Jan 14, 2022