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

NCT ID: NCT05844709

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-10
• Study Completion Date: 2023-07-04

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.

Conditions

Intraventricular Hemorrhage of Prematurity; Nursing Caries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Experimental group

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

IVH care Bundle

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Fu-Chang Tsai

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

Peiyi ,Lu

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202107092RIND

Identifier Type: -

Identifier Source: org_study_id