Effect of Right Lateral Position on Ventilated Preterm Neonates

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Right Lateral Position With Head Elevation on Tracheal Aspirate Pepsin in Ventilated Preterm Neonates: Randomized Controlled Trial

Conditions
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Gastro Esophageal Reflux

Intervention / Treatment
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* Behavioral: positioning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: right lateral position group<br>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. | Behavioral: positioning<br>* Positioning neonates for 6 hours either in right lateral position or supine position<br>|
| Active Comparator: supine position group<br>Neonates kept in supine position for 6 hours with head tilted 30 degrees upward. Infants were fed while in their positions via feeding tube. | Behavioral: positioning<br>* Positioning neonates for 6 hours either in right lateral position or supine position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |