Clinical Trials Logo
  1. Home
  2. Nursing Caries
  3. NCT05844709
  4. Details
NCT05844709 Clinical Trial

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

Nursing Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05844709
Other study ID # 202107092RIND
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2022
Est. completion date July 4, 2023

Study information
Verified date February 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date July 4, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 1 Month
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Taiwan Peiyi ,Lu Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of intraventricular hemorrhage Grading of Intraventricular Hemorrhage 72 postnatal hours
Primary The incidence of intraventricular hemorrhage Grading of Intraventricular Hemorrhage 168 postnatal hours
Secondary 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
Secondary Mortality neonatal death From date of admission until the date of death from any cause up to 4 postnatal weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05302505 - Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients N/A
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05326854 - NAVIGATION ASSISTED CARE PROGRAM AND TERMINATION OF PREGNANCY N/A
Completed NCT04127097 - The Effect of Watching Cartoons During Treatment on Children's Anxiety and Fear Levels N/A
Completed NCT05057078 - The Effect of Mindfulness Program on Spiritual Well-BeingBreast Cancer Patients N/A
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Not yet recruiting NCT05438823 - Technology Supported Education Program Based on Human Care Theory N/A
Completed NCT05100524 - Motivational Interview for Daily Living Activities in Elderly People Undergoing Total Knee Replacement N/A
Completed NCT03645213 - Two Different Distraction Methods on Pain and Fear During Venipuncture in Children N/A
Active, not recruiting NCT06053957 - The Effect of Early Mobilization on Postoperative Recovery in Abdominal Surgery N/A
Completed NCT06112600 - The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination N/A
Completed NCT04676932 - Hysterosalpingography and Comfort Theory N/A
Completed NCT04961463 - Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model N/A
Completed NCT04118322 - The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy N/A
Completed NCT05509621 - The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation N/A
Completed NCT04827849 - Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby N/A
Completed NCT05877937 - Humor Therapy and Rheumatoid Arthritis N/A
Completed NCT05129839 - Use of Lightened and Musical Baby Mobile in a Pediatric Emergency Clinic N/A
Completed NCT04121247 - Nonpharmacological Approaches and Parental Education in Children With Sickle Cell Disease N/A
Completed NCT06389929 - Do the Health Education Materials Developed in the Gynecology and Diseases Nursing Course Affect Students' Teaching Material Motivation and Material Design Self-Efficacy Beliefs? N/A