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

NCT01584375 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2014-10-31

No results posted yet for this study

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.

Conditions

  • Intraventricular Hemorrhage

Interventions

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

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.

Sponsors & Collaborators

  • King Abdullah International Medical Research Center

    collaborator OTHER

  • King Abdul Aziz General Hospital

    lead OTHER_GOV

Principal Investigators

  • Sameer Al-Abdi, SSCP, FRCPCH · King Abdulaziz Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
2 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584375 on ClinicalTrials.gov