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The Setting and Effect Evaluation of QT in NICU

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05192668
Enrollment
124
Registered
2022-01-14
Start date
2020-12-01
Completion date
2021-12-31
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Birth Weight Infant

Keywords

Quiet Time, Weight

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.

Interventions

OTHERQuiet 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

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
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.

Design outcomes

Primary

MeasureTime frameDescription
Mean weekly gain in weight of VLBWIsFrom 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026