NIDCAPNCT05166720
Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)
A study testing NIDCAP care in people with NIDCAP, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
In order to help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to the intervention group, and observed the compliance of nurses in the intervention group to… Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- NIDCAP
- What is being tested?
- NIDCAP care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Mar 2022
- 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;
- OI (oxygenation index >300)
Who cannot join
- Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
- Newborn who did not achieved 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: Clinical Application of the Best Evidence of NIDCAP in Very Low Birth Weight Infants
In order to help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to the intervention group, and observed the compliance of nurses in the intervention group to the application of evidence, and the short-term outcomes of VLBWI.
- Conditions
- NIDCAP
- Being tested
- NIDCAP care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIDCAP careBehavioural
NIDCAP care was performed according to the best evidence of NIDCAP
| Study group | Role | What they receive |
|---|---|---|
| NIDCAP care | Experimental | The training core group was formed by the project team. After a one-month clinical unified training on the best evidence of NIDCAP for the VLBW nursing professional group, the best evidence of NIDCAP was applied to the intervention group. Receives: Behavioral: NIDCAP care |
| routine nursing care | No intervention | routine nursingPerform routine care for NICU infants according to the nursing routine of each hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean length of stay of VLBWI
The average length of stay of VLBWI in the intervention group minus the average length of stay of VLBWI in the control group
Measured: From the day the VLBWI admitted to the day VLBWI discharged, about two months.
Secondary outcomes (1)
Nurse compliance with NIDCAP evidence content
Members of the study core team will regularly check the NICU nurse's performance by using the checklist. The number of times the NICU nurse performed specified operations divided by the total number of inspections. The checklist includes: Whether bed units and equipments are placed in accordance with the requirements? Whether sound is controlled in the NICU? Whether the skin of VLBWI is taking good care of, etc. Points are awarded if the requirements are met. Higher scores indicate better nurse compliance.
Measured: From the beginning of the NIDCAP intervention to the end of the NIDCAP intervention, about three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NIDCAPStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 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
- NCT05166720
- Sponsor's protocol ID
- Huxiaojing
- Status last verified
- Feb 2023
- First submitted
- 24 Oct 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Research Group of Developmental Care for Very Low Birth Weight Infants in China; Lyu T, Ye R, Li LL, Zhang LL, Xiao J, Ma YL, Li F, Rong H, Liu D, Wang H, Wang Y, Gu WW, Xuan Y, Chen X, Fan QL, Tang YF, Huang XH, Qin A, Zhang YL, Dou Y, Hu XJ. The effect of developmental care on the length of hospital stay and family centered care practice for very low birth weight infants in neonatal intensive care units: A cluster randomized controlled trial. Int J Nurs Stud. 2024 Aug;156:104784. doi: 10.1016/j.ijnurstu.2024.104784. Epub 2024 May 5.
PubMed 38788261
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of the Best Evidence of NIDCAP in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT05166720
- Acronym / sponsor ID
- Huxiaojing
- Conditions
- NIDCAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Dec 2021 (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 help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to the intervention group, and observed the compliance of nurses in the intervention group to the application of evidence, and the short-term outcomes of VLBWI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIDCAP care | Experimental | Behavioral: NIDCAP careThe training core group was formed by the project team. After a one-month clinical unified training on the best evidence of NIDCAP for the VLBW nursing professional group, the best evidence of NIDCAP was applied to the intervention group. |
| routine nursing care | No intervention | –routine nursingPerform routine care for NICU infants according to the nursing routine of each hospital |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight <1500g;
- admit within 24 hours of birth;
- The guardian signs the informed consent;
- OI (oxygenation index >300)
Key exclusion criteria (2 listed)
- Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
- Newborn who did not achieved 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 |
|---|---|---|
| NIDCAP careNIDCAP care was performed according to the best evidence of NIDCAP | Behavioural | NIDCAP care |
Primary outcome
Mean length of stay of VLBWI
Time frame: From the day the VLBWI admitted to the day VLBWI discharged, about two months.
The average length of stay of VLBWI in the intervention group minus the average length of stay of VLBWI in the control group
1 secondary outcome
Nurse compliance with NIDCAP evidence content
Time frame: From the beginning of the NIDCAP intervention to the end of the NIDCAP intervention, about three months.
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 28 Feb 2023.
- Derived from this study: PubMed 38788261Research Group of Developmental Care for Very Low Birth Weight Infants in China; Lyu T, Ye R, Li LL, Zhang LL, Xiao J, Ma YL, Li F, Rong H, Liu D, Wang H, Wang Y, Gu WW, Xuan Y, Chen X, Fan QL, Tang YF, Huang XH, Qin A, Zhang YL, Dou Y, Hu XJ. The effect of developmental care on the length of hospital stay and family centered care practice for very low birth weight infants in neonatal intensive care units: A cluster randomized controlled trial. Int J Nurs Stud. 2024 Aug;156:104784. doi: 10.1016/j.ijnurstu.2024.104784. Epub 2024 May 5.
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 NIDCAP care in people with NIDCAP, 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 4 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 28 Feb 2023. 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 length of stay of VLBWI (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?
On the ClinicalTrials.gov record for NCT05166720, which also lists 1 linked publication.
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 28 Feb 2023.