Effect of Right Lateral Position on Ventilated Preterm Neonates

Not Applicable

Completed

• Conditions: Gastro Esophageal Reflux
• Interventions: Behavioral: positioning

• Registration Number: NCT03258528
• Lead Sponsor: Ain Shams University

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).

Study Timeline

• Study Start: 2016-03-05
• Primary Completion: 2016-12-14
• Study Completion: 2016-12-14
• Status Verified: 2017-08
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Study First Posted: 2017-08-23
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine position group	positioning	Neonates kept in supine position for 6 hours with head tilted 30 degrees upward. Infants were fed while in their positions via feeding tube.
right lateral position group	positioning	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.

Primary Outcome Measures

Name	Time	Method
tracheal aspirate pepsin	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