The Setting and Effect Evaluation of QT in NICU

January 13, 2022 updated by: Children's Hospital of Fudan University

The Setting and Effect Evaluation of Quiet Time in Neonatal Intensive Care Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean weekly gain in weight of VLBWIs
Time Frame: 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
From the day the VLBWI admitted to the day VLBWI discharged, about two months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2021]296

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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