Positioning and Gastric Aspiration in Ventilated Premature Infants

Respiratory Aspiration of Gastric Contents Clinical Trial

Official title:

Positioning and Gastric Aspiration in Ventilated Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016651
• Other study ID #: 20120101
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: December 16, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Aspiration of Gastric Contents

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University Children's Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pepsin concentration in tracheal aspirate		6 hours after intervention	No