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

Completed

• Conditions: Intraventricular Hemorrhage of Prematurity; Nursing Caries
• Interventions: Other: IVH care Bundle

• Registration Number: NCT05844709
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

A quasi-experimental study design was employed and a total of 230 preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks will be recruited at the neonatal intensive care unit of National Taiwan University Hospital. The infants will be divided into 200 in the control group and 30 in the experimental group. Enrollment began after approval was granted by the Institutional Review Board. Eligible hospitalized preterm infants that met the inclusion criteria from January 2017 to December 2029 were selected for the control group by retrospective cohort and matched by the gestational age, birth weight and delivery method with the experimental group. 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. The study tools include 1. Intervention Tools: small towel or head positioning pillow (Tortle Midliner) and timer; 2. Data collection: Self-created questionnaire on awareness and behavior for preventing intraventricular hemorrhage in preterm infants in nurses, medical record and bundle care implementation record. The data were analyzed by descriptive statistics, t-test, Chi-square test and Logistic regression using SPSS 26 statistical software. The expected results are reduction in the incidence of intraventricular hemorrhage, the length of stay in the intensive care unit and mortality.

Study Timeline

• Study Start: 2022-09-10
• Status Verified: 2023-02
• Study First Submitted: 2023-02-23
• Primary Completion: 2023-04-15
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Study Completion: 2023-07-04
• Last Update Submitted: 2023-07-23
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	IVH care Bundle	The infants will be divided into 30 in the experimental group.

Primary Outcome Measures

Name	Time	Method
The incidence of intraventricular hemorrhage	168 postnatal hours	Grading of Intraventricular Hemorrhage

Secondary Outcome Measures

Name	Time	Method
Mortality	From date of admission until the date of death from any cause up to 4 postnatal weeks	neonatal death
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	Inpatient days

Trial Locations

Locations (1)

Peiyi ,Lu; 🇨🇳 Taipei, Taiwan