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

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.

Study Overview

• Status: Completed
• Conditions: Nursing Caries; Intraventricular Hemorrhage of Prematurity
• Intervention / Treatment: Other: IVH care Bundle

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 Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

• Study Contact: Name: Pei-Yi Lu; Phone Number: 0988225326; Email: peiyi2500@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Peiyi ,Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	neonatal death	From date of admission until the date of death from any cause up to 4 postnatal weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Daniel Fu-Chang Tsai, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): July 4, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: premature infants; bundle care; Intraventricular hemorrhage (IVH)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 202107092RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No