Clinical trial NCT01863043: Aspiration of Residual Gastric Contents
Official title: Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Nutrition, Enteral
Keywords: Premature Infant
Nutrition
Enteral
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-05-27
Enrollment: 146
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Enteral Intake on Day of Life 7
timeFrame: Day of life 7
measure: Enteral Intake on Day of Life 14
timeFrame: Day of life 14
measure: Enteral Intake on Day of Life 21
timeFrame: Day of life 21
measure: Enteral Intake on Day of Life 28
timeFrame: Day of life 28
measure: Enteral Intake at Day of Life 35
timeFrame: Day of life 35
measure: Enteral Intake on Day of Life 42
timeFrame: Day of life 42
Secondary outcomes:
measure: Days to Reach Full Feeds
timeFrame: baseline to approximately 42 days
measure: Hours Receiving Parenteral Nutrition
timeFrame: Baseline to 42 days
measure: Hours of Central Line Access
timeFrame: Baseline to 42 days
measure: Highest Alkaline Phosphatase Level
timeFrame: baseline to 42 days
measure: Occurrence of Cholestasis
timeFrame: Baseline to 42 days
measure: Level of Direct Bilirubin
timeFrame: Baseline to 42 days. highest value reported
measure: Length of Hospital Stay
timeFrame: baseline to approximately 3 months
measure: Episodes of Late Onset Sepsis
timeFrame: 4 to 42 days
measure: Episodes of Necrotizing Enterocolitis
timeFrame: Baseline to 42 days
measure: Episodes of Ventilator Associated Pneumonia
timeFrame: baseline to 42 days
measure: Episodes of Aspiration Pneumonia
timeFrame: baseline to 42 days
measure: Episodes of a Positive Tracheal Culture
timeFrame: Baseline to 42 days
measure: Episodes of 2 or More Positive Tracheal Aspirate Cultures
timeFrame: Baseline to 42 days
measure: Episodes of Bronchopulmonary Dysplasia
timeFrame: Baseline to approximately 3 months
measure: Highest Tracheal Pepsin Level
timeFrame: Baseline to 42 days
measure: Days of Invasive Ventilation
timeFrame: Baseline to approximately 3 months
measure: Number of Infants Who Died
timeFrame: Baseline to 42 days
measure: Number of Abdominal Radiographs
timeFrame: baseline to 42 days
measure: Episodes of Abdominal Distension
timeFrame: Baseline to 42 days
measure: Emesis
timeFrame: baseline to 42 days
measure: Weight
timeFrame: 42 days
measure: Head Circumference
timeFrame: 42 days
measure: Length
timeFrame: 42 days
measure: Presence of Blood in Stools
timeFrame: baseline to 42 days
measure: Level of Fecal Calprotectin
timeFrame: 42 days
measure: Serum Gastrin Level
timeFrame: baseline to 21 days
measure: Serum Motilin Level
timeFrame: baseline to 21 days
measure: Fecal S100A12
timeFrame: 42 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie A Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Aspiration and Evaluation of Gastric Residuals on Intestinal Inflammation, Bleeding, and Gastrointestinal Peptide Level. J Pediatr. 2020 Feb;217:165-171.e2. doi: 10.1016/j.jpeds.2019.10.036. Epub 2019 Nov 19.
citation: Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Gastric Residual Evaluation on Enteral Intake in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2019 Jun 1;173(6):534-543. doi: 10.1001/jamapediatrics.2019.0800.