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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05844709
Collaborator
(none)
230
1
14.7
15.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
230 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants
Actual Study Start Date :
Sep 10, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The incidence of intraventricular hemorrhage [72 postnatal hours]

    Grading of Intraventricular Hemorrhage

  2. The incidence of intraventricular hemorrhage [168 postnatal hours]

    Grading of Intraventricular Hemorrhage

Secondary Outcome Measures

  1. 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

  2. Mortality [From date of admission until the date of death from any cause up to 4 postnatal weeks]

    neonatal death

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 1 Month
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peiyi ,Lu Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05844709
Other Study ID Numbers:
  • 202107092RIND
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023