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

NCT ID: NCT01584375

Last Updated: 2014-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-04-30

Brief 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 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.

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.

Conditions

Intraventricular Hemorrhage

Keywords

Intraventricular hemorrhage; Preterm infant; Midline head position; Lateral head Position

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Flat midline head position

Group Type: OTHER

Flat midline head position

Intervention Type: OTHER

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.

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Right flat lateral head position

Group Type: OTHER

Right flat lateral head position

Intervention Type: OTHER

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.

Interventions

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.

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Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

FM; rFL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 2 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: collaborator

King Abdul Aziz General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Sameer Al-Abdi

Consultant Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameer Al-Abdi, SSCP, FRCPCH

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz Hospital

Locations

Almana General Hospital

Al-Ahsa, Eastern Province, Saudi Arabia

King Abdulaziz Hospital

Al-Ahsa, Eastern Province, Saudi Arabia

King Abdulaziz Medical City

Jeddah, Mecca Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

IRBC/084/12

Identifier Type: OTHER

Identifier Source: secondary_id

RE11/022

Identifier Type: -

Identifier Source: org_study_id