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

Nursing Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05844709
• Other study ID #: 202107092RIND
• Status: Completed
• Start date: September 10, 2022
• Est. completion date: July 4, 2023

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 4, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage of Prematurity
• Nursing Caries

Intervention

Other:
• IVH care Bundle
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.

Locations

Country	Name	City	State
Taiwan	Peiyi ,Lu	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of intraventricular hemorrhage	Grading of Intraventricular Hemorrhage	72 postnatal hours
Primary	The incidence of intraventricular hemorrhage	Grading of Intraventricular Hemorrhage	168 postnatal hours
Secondary	The length of stay in the intensive care unit	Inpatient days	From date of admission until the date of leave Neonatal intensive care unit up to 48 weeks
Secondary	Mortality	neonatal death	From date of admission until the date of death from any cause up to 4 postnatal weeks