Effect of Right Lateral Position on Ventilated Preterm Neonates
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
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
March 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2016
CompletedFirst Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedAugust 23, 2017
August 1, 2017
9 months
August 18, 2017
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
tracheal aspirate pepsin
Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured
6 hours
Study Arms (2)
right lateral position group
ACTIVE COMPARATORNeonates kept in the right lateral position for 6 hours with head tilted 30 degree upward with rolled towel supports the infant back at 90 degree angle on the bed.
supine position group
ACTIVE COMPARATORNeonates kept in supine position for 6 hours with head tilted 30 degrees upward. Infants were fed while in their positions via feeding tube.
Interventions
Positioning neonates for 6 hours either in right lateral position or supine position
Eligibility Criteria
You may not qualify if:
- Neonates with perinatal asphyxia, intracranial hemorrhage grade 3 or 4, periventricular leukomalacia, major congenital anomalies, gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedatives were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal investigator
Study Record Dates
First Submitted
August 18, 2017
First Posted
August 23, 2017
Study Start
March 5, 2016
Primary Completion
December 14, 2016
Study Completion
December 14, 2016
Last Updated
August 23, 2017
Record last verified: 2017-08