Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants

NCT05844709 | Completed

• 1 other identifier: 202107092RIND
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Existing measures to prevent intraventricular hemorrhage in preterm infants include preventing premature delivery, pre-natal administration of corticosteroid, active treatment of chorioamnionitis, and improvement of postnatal resuscitation and transfer process. Many overseas studies show that nursing care can reduce the risk of intraventricular hemorrhage and death, but there is no such study in Taiwan. Objective: to explore the effect of bundle nursing care on prevention of IVH in premature infants.

Conditions

Intraventricular Hemorrhage of Prematurity; Nursing Caries

Keywords

premature infants; bundle care; Intraventricular hemorrhage (IVH)

Outcome Measures

Primary Outcomes (2)

• The incidence of intraventricular hemorrhage

  Grading of Intraventricular Hemorrhage

  72 postnatal hours

• The incidence of intraventricular hemorrhage

  Grading of Intraventricular Hemorrhage

  168 postnatal hours

Secondary Outcomes (2)

• The length of stay in the intensive care unit

  From date of admission until the date of leave Neonatal intensive care unit up to 48 weeks

• Mortality

  From date of admission until the date of death from any cause up to 4 postnatal weeks

Study Arms (2)

Control group

The infants will be divided into 200 in the control group. Eligible hospitalized preterm infants that met the inclusion criteria from January 2017 to December 2019 were selected for the control group by retrospective cohort.

Experimental group

The infants will be divided into 30 in the experimental group.

Other: IVH care Bundle

Interventions

IVH care Bundle OTHER

The experimental group received bundle nursing care within 3 days after birth in addition to routine nursing care after consent was given and the informed consent form was signed. IVH care Bundle: 1. Maintaining midline head position 2. Avoid prone, place in supine or side-lying position 3. Incubator tilted 15-30 degrees 4. Slow withdrawal and flushing for UAC, UVC, and PAL.

Experimental group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Very Low Birth Weight(VLBW) : Preterm infants with birth weight less than 1500g. Intraventricular hemorrhage (IVH) is one of the serious complications in preterm infants and is present in about 25-30% of VLBW, which is related to long-term neurological sequelae and mortality.

You may qualify if:

• Inborn Preterm infants
• Preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks

You may not qualify if:

• Preterm infants with congenital malformations
• Genetic syndromes
• Congenital infections of the TORCHS group(syphilis, rubella, herpes, toxoplasmosis, and cytomegalovirus)
• Resuscitation and Pneumothorax at birth.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Peiyi ,Lu

Taipei, Taiwan

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Daniel Fu-Chang Tsai

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: May 6, 2023
• Study Start: September 10, 2022
• Primary Completion: April 15, 2023
• Study Completion: July 4, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)