Clinical trial NCT05844709: Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants
Official title: Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraventricular Hemorrhage of Prematurity
Nursing Caries
Keywords: premature infants
bundle care
Intraventricular hemorrhage (IVH)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 178
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The incidence of intraventricular hemorrhage
timeFrame: 72 postnatal hours
measure: The incidence of intraventricular hemorrhage
timeFrame: 168 postnatal hours
Secondary outcomes:
measure: The length of stay in the intensive care unit
timeFrame: From date of admission until the date of leave Neonatal intensive care unit up to 48 weeks
measure: Mortality
timeFrame: From date of admission until the date of death from any cause up to 4 postnatal weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Peiyi ,Lu
Study officials:
affiliation: National Taiwan University Hospital
name: Daniel Fu-Chang Tsai
role: STUDY_CHAIR
References: