Effect of Right Lateral Position on Ventilated Preterm Neonates
Primary Purpose
Gastro Esophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
positioning
Sponsored by
About this trial
This is an interventional prevention trial for Gastro Esophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- A total of 60 preterm neonates < 35 weeks gestational age were enrolled in the study, Inclusion criteria were tracheal intubated mechanically ventilated neonates for more than 72 hours, feeding >30ml/kg/day via nasogastric tube.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
right lateral position group
supine position group
Arm Description
Neonates 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.
Neonates kept in supine position for 6 hours with head tilted 30 degrees upward. Infants were fed while in their positions via feeding tube.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03258528
Brief Title
Effect of Right Lateral Position on Ventilated Preterm Neonates
Official Title
Effect of Right Lateral Position With Head Elevation on Tracheal Aspirate Pepsin in Ventilated Preterm Neonates: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 5, 2016 (Actual)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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. Ventilatory settings were observed before and during the intervention and neonates were followed up for development of bronchopulmpnary dysplasia (BPD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
right lateral position group
Arm Type
Active Comparator
Arm Description
Neonates 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.
Arm Title
supine position group
Arm Type
Active Comparator
Arm Description
Neonates kept in supine position for 6 hours with head tilted 30 degrees upward.
Infants were fed while in their positions via feeding tube.
Intervention Type
Behavioral
Intervention Name(s)
positioning
Intervention Description
Positioning neonates for 6 hours either in right lateral position or supine position
Primary Outcome Measure Information:
Title
tracheal aspirate pepsin
Description
Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured
Time Frame
6 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A total of 60 preterm neonates < 35 weeks gestational age were enrolled in the study, Inclusion criteria were tracheal intubated mechanically ventilated neonates for more than 72 hours, feeding >30ml/kg/day via nasogastric tube.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Right Lateral Position on Ventilated Preterm Neonates
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