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

Intraventricular Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01584375
• Other study ID #: RE11/022
• Secondary ID: IRBC/084/12
• Status: Terminated
• Phase: N/A
• First received: April 21, 2012
• Last updated: October 30, 2014
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: November 2013
• Source: King Abdul Aziz General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
Saudi Arabia	Almana General Hospital	Al-Ahsa	Eastern
Saudi Arabia	King Abdulaziz Hospital	Al-Ahsa	Eastern
Saudi Arabia	King Abdulaziz Medical City	Jeddah	Makkah

Sponsors (2)

Lead Sponsor	Collaborator
King Abdul Aziz General Hospital	King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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: Preterm infants less than 28 weeks of gestation.; Singletons.; Multiple gestations.; 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.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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.	First 168 hours of life.	No
Secondary	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.	First 168 hours of life.	No
Secondary	Diagnosis of IVH	Progression of IVH which will be diagnosed within the first 12 HOL.	First 168 hours of life	No