Effect of Right Lateral Position on Ventilated Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-05

Study Completion Date

2016-12-14

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.

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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).

Conditions

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Gastro Esophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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right lateral position group

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.

Group Type ACTIVE_COMPARATOR

positioning

Intervention Type BEHAVIORAL

Positioning neonates for 6 hours either in right lateral position or supine position

supine position group

Neonates kept in supine position for 6 hours with head tilted 30 degrees upward.

Infants were fed while in their positions via feeding tube.

Group Type ACTIVE_COMPARATOR

positioning

Intervention Type BEHAVIORAL

Positioning neonates for 6 hours either in right lateral position or supine position

Interventions

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positioning

Positioning neonates for 6 hours either in right lateral position or supine position

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No