Aspiration of Residual Gastric Contents

Infant, Premature Clinical Trial

Official title:

Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863043
• Other study ID #: IRB201501174- N
• Secondary ID: 1R01NR014019-01A
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infant, Premature
• Nutrition, Enteral
• Premature Birth

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