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

October 30, 2014 updated by: Dr. Sameer Al-Abdi, King Abdul Aziz General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

    1. Within first 12 HOL.
    2. At about 168 HOL.

  2. Otherwise, investigators will carry HUS according to established IVH diagnosis guidelines:

    1. As early as a clinical suspicion of IVH is raised.
    2. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Eastern
      • Al-Ahsa, Eastern, Saudi Arabia, 31982
        • Almana General Hospital
      • Al-Ahsa, Eastern, Saudi Arabia, 31982
        • King AbdulAziz Hospital
    • Makkah
      • Jeddah, Makkah, Saudi Arabia, 21423
        • King Abdulaziz Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 hour to 2 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Lethal congenital anomalies.
  2. Hypoxic ischemic encephalopathy.
  3. Need external cardiac compression or epinephrine administration at birth.
  4. Outborns.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Flat midline head position
Other: Flat midline head position

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.

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

Other Names:
  • FM
OTHER: Right flat lateral head position
Other: Right flat lateral head position
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.
Other Names:
  • rFL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All grade IVH incidence
Time Frame: First 168 hours of life.
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.
First 168 hours of life.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of IVH
Time Frame: First 168 hours of life.

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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.

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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Subgroup analysis
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Complications
Time Frame: First 168 hours of life.
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.
First 168 hours of life.
Diagnosis of IVH
Time Frame: First 168 hours of life
Progression of IVH which will be diagnosed within the first 12 HOL.
First 168 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Abdul Aziz General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King Abdullah International Medical Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sameer Al-Abdi, SSCP, FRCPCH, King AbdulAziz Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RE11/022
  • IRBC/084/12 (OTHER: KING ABDULLAH INTERNATIONAL MEDICAL RESEARCH CENTER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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