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Completed

NCT Number: NCT05844709

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.

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Key information

Conditions

Intraventricular Hemorrhage of Prematurity Female Urogenital Diseases and Pregnancy Complications Nursing Caries Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Peiyi ,Lu

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVH care Bundle

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.

Primary outcomes

  1. The incidence of intraventricular hemorrhage

    Time frame: 72 postnatal hours

    Grading of Intraventricular Hemorrhage

  2. The incidence of intraventricular hemorrhage

    Time frame: 168 postnatal hours

    Grading of Intraventricular Hemorrhage

Secondary outcomes

  1. The length of stay in the intensive care unit

    Time frame: From date of admission until the date of leave Neonatal intensive care unit up to 48 weeks

    Inpatient days

  2. Mortality

    Time frame: From date of admission until the date of death from any cause up to 4 postnatal weeks

    neonatal death

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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