Intraventricular Hemorrhage of PrematurityNCT05844709
Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants
An observational study of Intraventricular Hemorrhage of Prematurity and Nursing Caries, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity, Nursing Caries
- What is being tested?
- IVH care Bundle
- How many people
- 178 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2022to 4 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Inborn Preterm infants
- Preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks
Who cannot join
- Preterm infants with congenital malformations
- Genetic syndromes
- Congenital infections of the TORCHS group(syphilis, rubella, herpes, toxoplasmosis, and cytomegalovirus)
- Resuscitation and Pneumothorax at birth.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- IVH care Bundle
- Keywords
- premature infants, bundle care, Intraventricular hemorrhage (IVH)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVH care BundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IVH care Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intraventricular hemorrhage
Grading of Intraventricular Hemorrhage
Measured: 72 postnatal hours
The incidence of intraventricular hemorrhage
Grading of Intraventricular Hemorrhage
Measured: 168 postnatal hours
Secondary outcomes (2)
The length of stay in the intensive care unit
Inpatient days
Measured: From date of admission until the date of leave Neonatal intensive care unit up to 48 weeks
Mortality
neonatal death
Measured: From date of admission until the date of death from any cause up to 4 postnatal weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start10 Sep 2022
- Primary completion15 Apr 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Fu-Chang Tsai, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844709
- Sponsor's protocol ID
- 202107092RIND
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nursing Care Bundle for the Prevention of Intraventricular Hemorrhage in Preterm Infants
- ClinicalTrials.gov ID
- NCT05844709
- Acronym / sponsor ID
- 202107092RIND
- Keywords
- premature infants, bundle care, Intraventricular hemorrhage (IVH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: IVH care BundleThe infants will be divided into 30 in the experimental group. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Inborn Preterm infants
- Preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks
Key exclusion criteria (4 listed)
- Preterm infants with congenital malformations
- Genetic syndromes
- Congenital infections of the TORCHS group(syphilis, rubella, herpes, toxoplasmosis, and cytomegalovirus)
- Resuscitation and Pneumothorax at birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVH care BundleThe 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. | Other | Experimental group |
Primary outcome
The incidence of intraventricular hemorrhage
Time frame: 72 postnatal hours
Grading of Intraventricular Hemorrhage
The incidence of intraventricular hemorrhage
Time frame: 168 postnatal hours
Grading of Intraventricular Hemorrhage
2 secondary outcomes
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
Mortality
Time frame: From date of admission until the date of death from any cause up to 4 postnatal weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fu-Chang Tsai study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraventricular Hemorrhage of Prematurity and Nursing Caries, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of intraventricular hemorrhage (time frame: 72 postnatal hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.