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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01863043
Other study ID # IRB201501174- N
Secondary ID 1R01NR014019-01A
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2013
Est. completion date January 22, 2019

Study information

Verified date June 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date January 22, 2019
Est. primary completion date October 8, 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Days
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
No aspiration of gastric contents
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
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.

Locations

Country Name City State
United States Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enteral Intake on Day of Life 7 The volume in mL/kg of feeds provided to infant on day of life 7 Day of life 7
Primary Enteral Intake on Day of Life 14 The volume in mL/kg of feeds provided to infant on day of life 7 Day of life 14
Primary Enteral Intake on Day of Life 21 The volume in mL/kg of feeds provided to infants on day of life 21 Day of life 21
Primary Enteral Intake on Day of Life 28 The volume in mL/kg of feeds provided to the infant on day of life 28 Day of life 28
Primary Enteral Intake at Day of Life 35 The volume in mL/kg of feeds provided to infants on day of life 35 Day of life 35
Primary Enteral Intake on Day of Life 42 The volume in mL/kg of feeds provided to infants on day of life 42 Day of life 42
Secondary Days to Reach Full Feeds Full feeds is defined as 120 milliliters per kilogram per day baseline to approximately 42 days
Secondary Hours Receiving Parenteral Nutrition The number of hours participants required parenteral nutriton Baseline to 42 days
Secondary Hours of Central Line Access The number of hours participants required central line access Baseline to 42 days
Secondary Highest Alkaline Phosphatase Level Highest level during the first 42 days baseline to 42 days
Secondary Occurrence of Cholestasis Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL Baseline to 42 days
Secondary Level of Direct Bilirubin Level of direct bilirubin on routine weekly or biweekly laboratory testing Baseline to 42 days. highest value reported
Secondary Length of Hospital Stay Days infant remains in hospital baseline to approximately 3 months
Secondary Episodes of Late Onset Sepsis Episodes of presumed or culture positive sepsis at > 3 days of life 4 to 42 days
Secondary Episodes of Necrotizing Enterocolitis Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater) Baseline to 42 days
Secondary Episodes of Ventilator Associated Pneumonia Episodes of ventilator associated pneumonia baseline to 42 days
Secondary Episodes of Aspiration Pneumonia Episodes of aspiration pneumonia on radiograph baseline to 42 days
Secondary Episodes of a Positive Tracheal Culture Episodes of a tracheal culture positive for bacteria Baseline to 42 days
Secondary Episodes of 2 or More Positive Tracheal Aspirate Cultures Episodes of 2 or more tracheal cultures positive for bacteria Baseline to 42 days
Secondary Episodes of Bronchopulmonary Dysplasia Episodes of bronchopulmonary dysplasia Baseline to approximately 3 months
Secondary Highest Tracheal Pepsin Level The highest level of pepsin obtained from endotracheal tube secretions Baseline to 42 days
Secondary Days of Invasive Ventilation Number of days infants required invasive ventilation Baseline to approximately 3 months
Secondary Number of Infants Who Died Number of infants who died during the 6 weeks study. Baseline to 42 days
Secondary Number of Abdominal Radiographs number of abdominal radiographs performed baseline to 42 days
Secondary Episodes of Abdominal Distension Episodes of increased abdominal girth by 2cm or greater Baseline to 42 days
Secondary Emesis Number of emesis episodes baseline to 42 days
Secondary Weight Weight at 6 weeks of age. Note infants were born weighing < 1500 grams 42 days
Secondary Head Circumference Head circumference at 42 days 42 days
Secondary Length Length at 42 days 42 days
Secondary Presence of Blood in Stools Proportion of guaiac positive stools. baseline to 42 days
Secondary Level of Fecal Calprotectin Level of calprotectin in stools 42 days
Secondary Serum Gastrin Level level of gastrin at 3 weeks baseline to 21 days
Secondary Serum Motilin Level Serum motilin level at 21 days baseline to 21 days
Secondary Fecal S100A12 Level of fecal S100A12 42 days
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