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

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.

Study Overview

• Status: Completed
• Conditions: NIDCAP
• Intervention / Treatment: Behavioral: NIDCAP care

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIDCAP care; 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.	Behavioral: NIDCAP care; NIDCAP care was performed according to the best evidence of NIDCAP
No Intervention: routine nursing care; routine nursingPerform routine care for NICU infants according to the nursing routine of each hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the day the VLBWI admitted to the day VLBWI discharged, about two months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the beginning of the NIDCAP intervention to the end of the NIDCAP intervention, about three months.

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: Huxiaojing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No