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CompletedNCT02016651Updated Dec 20, 2013

Positioning and Gastric Aspiration in Ventilated Premature Infants

An interventional study of Right side position in Respiratory Aspiration of Gastric Contents, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 3 Days to 28 Days. Per ClinicalTrials.gov, last updated 2013-12-20.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
3 Days to 28 Days
Sex
All
01

Study 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.

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Conditions studied

  • Respiratory Aspiration of Gastric Contents
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In context

Respiratory Aspiration of Gastric Contents

29 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.

This study's enrollment of 34 is below the median of 111 across 17 interventional studies indexed under Respiratory Aspiration of Gastric Contents.

Browse Respiratory Aspiration of Gastric Contents studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Days to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Right side position

    Premature infants on mechanical ventilation are kept on their right side

    Behavioral: Right side position

  • No intervention
    Supine position

    Premature infants on mechanical ventilation are kept on their back

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.

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What researchers measure

Primary outcomes

  1. Pepsin concentration in tracheal aspirate

    Time frame: 6 hours after intervention

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Study locations

1 site
  • Cairo University Children's Hospital
    Cairo, Cairo Governorate 00000, Egypt
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References and documents

Publications

  • Farhath S, He Z, Nakhla T, Saslow J, Soundar S, Camacho J, Stahl G, Shaffer S, Mehta DI, Aghai ZH. Pepsin, a marker of gastric contents, is increased in tracheal aspirates from preterm infants who develop bronchopulmonary dysplasia. Pediatrics. 2008 Feb;121(2):e253-9. doi: 10.1542/peds.2007-0056. PubMed 18245400 ↗
  • Aly H, Badawy M, El-Kholy A, Nabil R, Mohamed A. Randomized, controlled trial on tracheal colonization of ventilated infants: can gravity prevent ventilator-associated pneumonia? Pediatrics. 2008 Oct;122(4):770-4. doi: 10.1542/peds.2007-1826. PubMed 18829800 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02016651
Lead sponsor
Cairo University
Responsible party
Hany Aly (Visiting Professor of Pediatrics, Cairo University) — Principal investigator
First posted
Dec 20, 2013
Start date
Jan 2012
Primary completion
Jul 2013
Completion
Dec 2013
Last update
Dec 20, 2013

Study contacts

Reem Mahmoud, MD
principal investigator · Cairo University Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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