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Completed

NCT Number: NCT05166720

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

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.

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Key information

Conditions

NIDCAP

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIDCAP care

Behavioral

NIDCAP care was performed according to the best evidence of NIDCAP

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.