The Setting and Effect Evaluation of QT in NICU

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.

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Key information

Conditions

Very Low Birth Weight Infant Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quiet time care

Other

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jan 14, 2022
Registry last updated: Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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