NCT01584375

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 31, 2014

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

April 21, 2012

Last Update Submit

October 30, 2014

Conditions

Intraventricular Hemorrhage

Keywords

Intraventricular hemorrhagePreterm infantMidline head positionLateral head Position

Outcome Measures

Primary Outcomes (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.

    First 168 hours of life.

Secondary Outcomes (10)

  • Severity of IVH

    First 168 hours of life.

  • Subgroup analysis

    First 168 hours of life.

  • Subgroup analysis

    First 168 hours of life.

  • Subgroup analysis

    First 168 hours of life.

  • Subgroup analysis

    First 168 hours of life.

  • +5 more secondary outcomes

Study Arms (2)

Flat midline head position

OTHER
Other: Flat midline head position

Right flat lateral head position

OTHER
Other: Right flat lateral head position

Interventions

Flat midline head positionOTHER

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. \--------------------------------------------------------------------------------

Also known as: FM
Flat midline head position
Right flat lateral head positionOTHER

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.

Also known as: rFL
Right flat lateral head position

Eligibility Criteria

Age1 Hour - 2 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Almana General Hospital

Al-Ahsa, Eastern Province, 31982, Saudi Arabia

Location

King Abdulaziz Hospital

Al-Ahsa, Eastern Province, 31982, Saudi Arabia

Location

King Abdulaziz Medical City

Jeddah, Mecca Region, 21423, Saudi Arabia

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sameer Al-Abdi, SSCP, FRCPCH

    King Abdulaziz Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neonatologist

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 25, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

October 31, 2014

Record last verified: 2013-11

Locations

SA(3)