MedDataX Logo

Positioning and Gastric Aspiration in Ventilated Premature Infants

NCT ID: NCT02016651

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Aspiration of Gastric Contents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Right side position

Premature infants on mechanical ventilation are kept on their right side

Group Type EXPERIMENTAL

Right side position

Intervention Type BEHAVIORAL

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

Supine position

Premature infants on mechanical ventilation are kept on their back

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hany Aly

Visiting Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reem Mahmoud, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University Children's Hospital

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18245400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18829800 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20120101

Identifier Type: -

Identifier Source: org_study_id