Positioning and Gastric Aspiration in Ventilated Premature Infants

NCT02016651 | Completed DMC

• 1 other identifier: 20120101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Aspiration of Gastric Contents

Outcome Measures

Primary Outcomes (1)

• Pepsin concentration in tracheal aspirate

  6 hours after intervention

Study Arms (2)

Right side position

EXPERIMENTAL

Premature infants on mechanical ventilation are kept on their right side

Behavioral: Right side position

Supine position

NO INTERVENTION

Premature infants on mechanical ventilation are kept on their back

Interventions

Right side position BEHAVIORAL

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

Right side position

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Children's Hospital

Cairo, Cairo Governorate, 00000, Egypt

Location

Related Publications (2)

• 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.

  PMID: 18245400 BACKGROUND

• 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.

  PMID: 18829800 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reem Mahmoud, MD

  Cairo University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor of Pediatrics

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

EG (1)