Aspiration of Residual Gastric Contents

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01863043
First received: May 22, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.


Condition Intervention
Infant, Premature
Nutrition, Enteral
Procedure: No aspiration of gastric contents
Procedure: Routine aspiration of gastric contents

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 24-hour enteral feeding intake in mL/kg [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach full feeds [ Time Frame: baseline to approximately 3 weeks ] [ Designated as safety issue: No ]
    Full feeds is defined as 120 milliliters per kilogram per day

  • Hours receiving parenteral nutrition [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Weekly or biweekly liver function tests [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
    level of direct bilirubin, alkaline phosphatase aspartate aminotransferase and alanine aminotransferase

  • Hours of central venous line access [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Episodes of late onset sepsis [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
  • Growth indices [ Time Frame: baselines to 6 weeks ] [ Designated as safety issue: No ]
    Weight, length, and head circumference

  • Length of hospital stay [ Time Frame: baseline to approximately 3 months ] [ Designated as safety issue: No ]
    Days infant remains in hospital

  • Episodes of necrotizing enterocolitis [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: Yes ]
    Episodes of radiologic evidence of necrotizing enterocolitis

  • Presence of blood in stools [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
    Positive or negative guaiac of all stools

  • Level of fecal calprotectin [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • serum gastrin level [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
  • motilin level [ Time Frame: baseline to 21 days ] [ Designated as safety issue: No ]
  • tracheal pepsin levels [ Time Frame: baseline to 35 days ] [ Designated as safety issue: No ]
  • presence of aspiration pneumonia [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
  • presence of ventilator associated pneumonia [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Routine aspiration of gastric contents
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Procedure: Routine aspiration of gastric contents
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Experimental: No aspiration of gastric contents
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
Procedure: No aspiration of gastric contents
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Detailed Description:

The participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. In addition, when a blood drawn is performed as regular care an extra amount with be taken. A test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. Stool samples will be collected. Participation could last up to approximately 6 to 8 weeks of age.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • born at 32 weeks of less of gestational age
  • birth weight </= to 1250 grams
  • receiving some enteral feedings by 72 hours of age
  • receiving parenteral feedings by 24 hours of age

Exclusion Criteria:

  • Congenital or chromosomal abnormalities
  • complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863043

Contacts
Contact: Leslie A Parker, PhD 352-273-6384 parkerla@ufl.edu

Locations
United States, Florida
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida Recruiting
Gainesville, Florida, United States, 32504
Contact: Leslie A Parker, PhD    352-215-9360    parkela@ufl.edu   
Principal Investigator: Leslie A Parker, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Leslie A Parker, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01863043     History of Changes
Other Study ID Numbers: NIH - 1R01NR014019-01A1, 1R01NR014019-01A1
Study First Received: May 22, 2013
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Florida:
Premature Infant
Nutrition
Enteral

ClinicalTrials.gov processed this record on October 23, 2014