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OpenTrials
Completed

NCT Number: NCT02016651

Positioning and Gastric Aspiration in Ventilated Premature Infants

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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Key information

Conditions

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

Age range

3 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Children's Hospital

Cairo, Cairo Governorate, 00000, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pepsin concentration in tracheal aspirate

    Time frame: 6 hours after intervention

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2013
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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