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Intraventricular HemorrhageNCT01584375

The Risk of Intraventricular Hemorrhage With Flat Midline Versus Right-Tilted Flat Lateral Head Positions

A study testing Flat midline head position and Right flat lateral head position in people with Intraventricular Hemorrhage, run by King Abdul Aziz General Hospital at 3 sites in Saudi Arabia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Intraventricular hemorrhage (IVH) in preterm infants is one of many devastating consequences of prematurity that have both acute and long-term sequelae. Turning a preterm infant's head to one side may increase intracranial pressure and occlude major ipsilateral veins in the neck, which could increase cerebral venous… Read more about this study

Who is it for?
Ages 1 hour to 2 hours
Conditions the study is for
Intraventricular Hemorrhage
What is being tested?
Flat midline head position and Right flat lateral head position
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
3 sitesSaudi Arabia
Study dates
Apr 2012to Apr 2015
Phase
Interventional
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 hour to 2 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Born at the three study NICUs.
  • Gestational age < 30 weeks.

Who cannot join

  • Lethal congenital anomalies.
  • Hypoxic ischemic encephalopathy.
  • Need external cardiac compression or epinephrine administration at birth.
  • Outborns.

Trial locations and contacts

3 sites in 1 country.

Saudi Arabia3 sites
  • Almana General Hospital

    Al-Ahsa, Eastern Province, 31982

  • King Abdulaziz Hospital

    Al-Ahsa, Eastern Province, 31982

  • King Abdulaziz Medical City

    Jeddah, Mecca Region, 21423

Other trials in Saudi Arabia

About this study

Official title: The Risk of Intraventricular Hemorrhage With Flat Midline Versus Right-Tilted Flat Lateral Head Positions in Preterm Infant Less Than 30 Weeks of Gestation: a Multicenter Randomized Control Trial

Intraventricular hemorrhage (IVH) in preterm infants is one of many devastating consequences of prematurity that have both acute and long-term sequelae. Turning a preterm infant's head to one side may increase intracranial pressure and occlude major ipsilateral veins in the neck, which could increase cerebral venous pressure and decrease cerebral venous drainage. Keeping preterm infants' heads in a slightly elevated midline position (side or supine) during the first 168 hours(HOL) has been recommended as one of the 10 potentially better practices to reduce the incidence of IVH in preterm infants. To the best of our knowledge, there has been no systematically collected clinical data quantifying the relationship between IVH and head position in preterm infants. However, the midline head position may challenge the well-known right neonatal head position preference. This preference continues until 3-6 months of age, after which preterm neonates keep their heads mainly in midline. The best head position for preterm neonates is still to be determined. Therefore, the investigators are aiming to conduct a large scale multicenter randomized control trial on order to answer the following research question: Does keeping heads of preterm infants less than 30 weeks of gestation in flat midline (FM) throughout the first 168 HOL reduce the risk of IVH compared to right flat lateral (rFL)? We hypothesized that keeping heads of preterm infants less than 30 weeks of gestation in FM throughout the first 168 HOL would reduce the risk of IVH compared to rFL.

Read the detailed description

Investigators will randomly assign infants lying on flat (zero degree) beds to be cared for either in a supine FM or a supine rFL head position throughout the first 168 HOL. Investigators will mount a sign on the incubator indicating the assigned head position to be maintained during the first 168 HOL. The goal is to keep the neonates' heads in their assigned positions throughout the first 168 HOL unless a medical indication required a change in position. The left flat lateral head position will be the back-up position whenever the medical conditions of the study neonates preclude maintaining the assigned head positions. The bedside nurse will check the correctness of the infants' head positions every 4 hours by using the built-in spirit (bubble) level of the open-bed incubators and an L-shaped ruler. Investigators are going to use an elbow connector of HUDSON RCI circuit (adult circuit) in a case SENSORMEDICS will be required for neonates in FM group. Investigators will watch and record pressure ulcers or technical difficulties arising from using high-frequency ventilation (HFV) in the infants in FM position. After their first 168 HOL, the study infants will be given routine nursing care provided in their NICU, including a change in head position every 6-12 hours or as needed on a slightly elevated bed. For obvious reasons, the medical team will be unmasked to the assigned head position. It will be left for the physician discretion for controversial/diversity issue (s) in neonatal care but it will be recorded.

Timing of HUS examinations

  1. All study neonates will have two screening head ultrasounds (HUS) as follows:
  2. Within first 12 HOL.
  3. At about 168 HOL.
  4. Otherwise, investigators will carry HUS according to established IVH diagnosis guidelines:
  5. As early as a clinical suspicion of IVH is raised.
  6. When IVH is detected, then a follow up HUS is repeated within 5-7 days later.

Diagnosis of IVH:

Ultrasound technicians or physicians who have been trained to perform HUS will perform a standard set of HUS views through the anterior fontanel with a high-quality modern real-time portable ultrasound machine with appropriate transducers. They will capture at least six coronal and five sagittal planes. Investigators will send a similar digital format copy of these images and earlier images (if any) to the three study pediatric radiologists who will be blinded to the head position assignments. They independently will report the absence or presence, lateralization (right, left or bilateral), extension, and grade of IVH according to Papile's grading criteria. They will send their reports to the principal investigator via email. If their reports are inconsistent, then diagnosis and grading of IVH will be based on the majority or the consensus among them if majority cannot be reached.

Analysis strategy for withdrawal, drop outs, and protocol violations as both of the following when appropriate:

  1. Intention to treat analysis.
  2. Per protocol analysis: Including only neonates who will have normal first 12 hours of life HUS, complete the study or develop IVH during the study period, and have their heads kept in the assigned head positions throughout study period (first 168 HOL)or until time of IVH diagnosis.
Being tested
Flat midline head position, Right flat lateral head position
Keywords
Intraventricular hemorrhage, Preterm infant, Midline head position, Lateral head Position
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flat midline head positionOther

    Also called FM

    Infant's chin will be kept at a 90±5 degree angle to the bed (the chin and nose being in line with the sternum) throughout the first 168 hours of life.

    --------------------------------------------------------------------------------

  • Right flat lateral head positionOther

    Also called rFL

    Infant's head will be tilted 85-90 degrees to right side (approximately the entire chin beyond the right nipple line) throughout the first 168 hours of life.

Study groups in NCT01584375
Study groupRoleWhat they receive
Flat midline head positionOtherNot described
Receives: Other: Flat midline head position
Right flat lateral head positionOtherNot described
Receives: Other: Right flat lateral head position

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All grade IVH incidence

    To compared all grade IVH incidence in a FM head position with that of a rFL head position in preterm infant less than 30 weeks of gestation.

    Measured: First 168 hours of life.

Secondary outcomes (10)
  1. Severity of IVH

    To compare Severity of IVH in a FM head position with that of a rFL head position.Investigators will calculate severity score of IVH according to our recent proposed (Al-Abdi 2011).* This proposed severity score is equal to the squared IVH grade of the worse side, plus the IVH grade of the other side, plus 5 for each hemisphere when it has extensive parenchymal involvement (> 2 brain territories), and plus 5 when there is a brain midline shift.

    • Al-Abdi SY. A severity score for intraventricular hemorrhage in preterm neonates. Saudi Med J. Dec 2011;32(12):1313-1314.

    Measured: First 168 hours of life.

  2. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in:

    1. Preterm infants less than 28 weeks of gestation.
    2. Singletons.
    3. Multiple gestations.
    4. Neonates who will complete the study, have normal first 12 hours of life HUS, and their heads will be kept in the assigned head positions of at least 85% of study duration.

    Measured: First 168 hours of life.

  3. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in neonates who will have normal first 12 hours of life HUS and their heads will be kept in the assigned head positions for the first 24-47 hours of life.

    Measured: First 168 hours of life.

  4. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in neonates who will have normal first 12 hours of life HUS and their heads will be kept in the assigned head positions for the first 48-71 hours of life.

    Measured: First 168 hours of life.

  5. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in neonates who will have normal first 12 hours of life HUS and their heads will be kept in the assigned head positions for the first 72-95 hours of life.

    Measured: First 168 hours of life.

  6. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in neonates who will have normal first 12 hours of life HUS and their heads will be kept in the assigned head positions for the first 96-119 hours of life.

    Measured: First 168 hours of life.

  7. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in neonates who will have normal first 12 hours of life HUS and their heads will be kept in the assigned head positions for the first 120-143 hours of life.

    Measured: First 168 hours of life.

  8. Subgroup analysis

    To compare all grade IVH incidence at about 168 HOL in a FM head position with that of a rFL head position in neonates who will have normal first 12 hours of life HUS and their heads will be kept in the assigned head positions for the first 144-167 hours of life.

    Measured: First 168 hours of life.

  9. Complications

    To compare incidence of: 1) Pressure ulcer as per calcification of the National Pressure Ulcer Advisory Panel (NPUAP) and ; 2) pressure alopecia in a FM head position with that of a rFL head position.

    Measured: First 168 hours of life.

  10. Diagnosis of IVH

    Progression of IVH which will be diagnosed within the first 12 HOL.

    Measured: First 168 hours of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2015 (estimated)
  4. Study completionApr 2015 (estimated)

Why it stopped: Due to low patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01584375
Sponsor's protocol ID
RE11/022
Other IDs
IRBC/084/12
Status last verified
Nov 2013
First submitted
21 Apr 2012
Last updated
31 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Flat midline head position and Right flat lateral head position in people with Intraventricular Hemorrhage, run by King Abdul Aziz General Hospital at 3 sites in Saudi Arabia.

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: stopped early, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Saudi Arabia. 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 was stopped early (reason given: Due to low patient recruitment). Results are not available in the source record.

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?

All grade IVH incidence (time frame: First 168 hours of life.). 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 31 Oct 2014.

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