NCT05192668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

December 27, 2021

Last Update Submit

January 13, 2022

Conditions

Very Low Birth Weight Infant

Keywords

Quiet TimeWeight

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Quiet time care

EXPERIMENTAL

Reduce noise and centralize medical or nursing operations in the NICU

Other: Quiet time care

Routine nursing care

NO INTERVENTION

Perform routine nursing care for the VLBWIs in the NICU

Interventions

Quiet time careOTHER

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

Quiet time care

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight \<1500g;
  • Admit within 24 hours of birth;
  • The guardian signs the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 14, 2022

Study Start

December 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 14, 2022

Record last verified: 2022-01

Locations

CN(1)