Positioning and Gastric Aspiration in Ventilated Premature Infants

N/ACompletedNCT02016651

Cairo University34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Respiratory Aspiration of Gastric Contents

Interventions

Right side positionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 3 DaysMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (1)

Cairo University Children's Hospital

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Pepsin concentration in tracheal aspirate

Time frame: 6 hours after intervention

Data from ClinicalTrials.gov

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