The Setting and Effect Evaluation of QT in NICU

Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05192668
• Other study ID #: [2021]296
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infant

Intervention

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

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From the day the VLBWI admitted to the day VLBWI discharged, about two months.