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Effect of Right Lateral Position on Ventilated Preterm Neonates

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03258528
Enrollment
60
Registered
2017-08-23
Start date
2016-03-05
Completion date
2016-12-14
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux

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).

Interventions

BEHAVIORALpositioning

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

2

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
tracheal aspirate pepsin6 hoursTracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026