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Positioning and Gastric Aspiration in Ventilated Premature Infants

Primary Purpose

Respiratory Aspiration of Gastric Contents

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Right side position

About this trial

This is an interventional prevention trial for Respiratory Aspiration of Gastric Contents

Eligibility Criteria

3 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cairo University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Right side position

Supine position

Arm Description

Premature infants on mechanical ventilation are kept on their right side

Premature infants on mechanical ventilation are kept on their back

Outcomes

Primary Outcome Measures

Pepsin concentration in tracheal aspirate

Secondary Outcome Measures

Full Information

NCT ID

NCT02016651

First Posted

December 16, 2013

Last Updated

December 16, 2013

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02016651

Brief Title

Positioning and Gastric Aspiration in Ventilated Premature Infants

Official Title

Positioning and Gastric Aspiration in Ventilated Premature Infants

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Aspiration of Gastric Contents

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Right side position

Arm Type

Experimental

Arm Description

Premature infants on mechanical ventilation are kept on their right side

Arm Title

Supine position

Arm Type

No Intervention

Arm Description

Premature infants on mechanical ventilation are kept on their back

Intervention Type

Behavioral

Intervention Name(s)

Right side position

Intervention Description

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

Primary Outcome Measure Information:

Title

Pepsin concentration in tracheal aspirate

Time Frame

6 hours after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Days

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reem Mahmoud, MD

Organizational Affiliation

Cairo University Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo University Children's Hospital

City

Cairo

ZIP/Postal Code

00000

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

18245400

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.

Results Reference

background

PubMed Identifier

18829800

Citation

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.

Results Reference

background

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Positioning and Gastric Aspiration in Ventilated Premature Infants

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