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Positioning and Gastric Aspiration in Ventilated Premature Infants

Positioning and Gastric Aspiration in Ventilated Premature Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02016651
Enrollment
34
Registered
2013-12-20
Start date
2012-01-31
Completion date
2013-12-31
Last updated
2013-12-20

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

Conditions

Respiratory Aspiration of Gastric Contents

Brief summary

Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific marker for aspiration. The objective of this study is to examine if TA pepsin will change when ventilated premature infants are positioned in two different positions; on their back vs. on their right side.

Interventions

BEHAVIORALRight side position

Enrolled infants are positioned on their back or right side. Tracheal aspirate is assessed for pepsin concentration as an index of aspiration.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Infants born between 28 and 32 weeks gestational age * postnatal age \> 72 hours * tracheally intubated and receiving conventional mechanical ventilation * feeding enterally more than 20 ml per day.

Exclusion criteria

* neurological insult in the form of perinatal asphyxia (pH \<7, base deficit more than 12, Apgar score at \< 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia * major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , * receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation

Design outcomes

Primary

MeasureTime frame
Pepsin concentration in tracheal aspirate6 hours after intervention

Countries

Egypt

Outcome results

None listed

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