Very Low Birth Weight InfantNCT05192668
The Setting and Effect Evaluation of QT in NICU
A study testing Quiet time care in people with Very Low Birth Weight Infant, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Quiet time care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight <1500g;
- Admit within 24 hours of birth;
- The guardian signs the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: 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.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Quiet time care
- Keywords
- Quiet Time, Weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Quiet time care | Experimental | Reduce noise and centralize medical or nursing operations in the NICU Receives: Other: Quiet time care |
| Routine nursing care | No intervention | Perform routine nursing care for the VLBWIs in the NICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the day the VLBWI admitted to the day VLBWI discharged, about two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192668
- Sponsor's protocol ID
- [2021]296
- Status last verified
- Jan 2022
- First submitted
- 27 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Setting and Effect Evaluation of Quiet Time in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05192668
- Acronym / sponsor ID
- [2021]296
- Conditions
- Very Low Birth Weight Infant
- Keywords
- Quiet Time, Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quiet time care | Experimental | Other: Quiet time careReduce noise and centralize medical or nursing operations in the NICU |
| Routine nursing care | No intervention | –Perform routine nursing care for the VLBWIs in the NICU |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight <1500g;
- Admit within 24 hours of birth;
- The guardian signs the informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quiet time careThis 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 | Other | Quiet time care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quiet time care in people with Very Low Birth Weight Infant, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean weekly gain in weight of VLBWIs (time frame: From the day the VLBWI admitted to the day VLBWI discharged, about two months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.