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Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)

Primary Purpose

NIDCAP

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

NIDCAP care

About this trial

This is an interventional supportive care trial for NIDCAP

Eligibility Criteria

undefined - 1 Day (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Birth weight <1500g;
admit within 24 hours of birth;
The guardian signs the informed consent;
OI (oxygenation index >300)

Exclusion Criteria:

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

Sites / Locations

Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NIDCAP care

routine nursing care

Arm Description

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.

routine nursingPerform routine care for NICU infants according to the nursing routine of each hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05166720

First Posted

October 24, 2021

Last Updated

February 26, 2023

Sponsor

Children's Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05166720

Brief Title

Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)

Official Title

Clinical Application of the Best Evidence of NIDCAP in Very Low Birth Weight Infants

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 the application of evidence, and the short-term outcomes of VLBWI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NIDCAP

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NIDCAP care

Arm Type

Experimental

Arm Description

Arm Title

routine nursing care

Arm Type

No Intervention

Arm Description

routine nursingPerform routine care for NICU infants according to the nursing routine of each hospital

Intervention Type

Behavioral

Intervention Name(s)

NIDCAP care

Intervention Description

NIDCAP care was performed according to the best evidence of NIDCAP

Primary Outcome Measure Information:

Title

Mean length of stay of VLBWI

Description

The average length of stay of VLBWI in the intervention group minus the average length of stay of VLBWI in the control group

Time Frame

From the day the VLBWI admitted to the day VLBWI discharged, about two months.

Secondary Outcome Measure Information:

Title

Nurse compliance with NIDCAP evidence content

Description

Time Frame

From the beginning of the NIDCAP intervention to the end of the NIDCAP intervention, about three months.

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Day

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Birth weight <1500g; admit within 24 hours of birth; The guardian signs the informed consent; OI (oxygenation index >300) Exclusion Criteria: 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

Facility Information:

Facility Name

Children's Hospital of Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201102

Country

China

12. IPD Sharing Statement

Learn more about this trial

Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)

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