N/A N=146 Randomized Supportive Care

Aspiration of Residual Gastric Contents

Infant, Premature · Nutrition, Enteral

Bottom Line

View on ClinicalTrials.gov: NCT01863043 ↗

Enrolled (actual)

146

Serious AEs

10.5%

Results posted

Jun 2023

Primary outcome: Primary: Enteral Intake on Day of Life 7 — 27.5; 22.6 mL/kg per day — p=0.27

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: No aspiration of gastric contents (Procedure); Routine aspiration of gastric contents (Procedure)
Age: Pediatric
Sex: All
Sponsor: University of Florida
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Enteral Intake on Day of Life 7	27.5; 22.6	0.27
PRIMARY Enteral Intake on Day of Life 14	83.2; 94.7	0.12
PRIMARY Enteral Intake on Day of Life 21	109.2; 117.7	0.28
PRIMARY Enteral Intake on Day of Life 28	119.4; 129.6	0.15
PRIMARY Enteral Intake at Day of Life 35	123.9; 137.2	0.03 sig
PRIMARY Enteral Intake on Day of Life 42	128.4; 141.6	0.03 sig
SECONDARY Days to Reach Full Feeds	18.1; 15.9	0.59
SECONDARY Hours Receiving Parenteral Nutrition	358.8; 356.8	0.64
SECONDARY Hours of Central Line Access	402.6; 398.6	0.95
SECONDARY Highest Alkaline Phosphatase Level	451; 495.5	0.95
SECONDARY Occurrence of Cholestasis	0.040; 0.057	0.23
SECONDARY Level of Direct Bilirubin	0.690; 0.671	0.98
SECONDARY Length of Hospital Stay	86.4; 79.1	0.01 sig
SECONDARY Episodes of Late Onset Sepsis	1.38; 0.97	0.08
SECONDARY Episodes of Necrotizing Enterocolitis	0.026; 0.008	0.25
SECONDARY Episodes of Ventilator Associated Pneumonia	0; 0	—
SECONDARY Episodes of Aspiration Pneumonia	0; 0	0.27
SECONDARY Episodes of a Positive Tracheal Culture	0.055; 0.088	0.17
SECONDARY Episodes of 2 or More Positive Tracheal Aspirate Cultures	0.015; 0.024	0.17
SECONDARY Episodes of Bronchopulmonary Dysplasia	0.512; 0.680	0.43
SECONDARY Highest Tracheal Pepsin Level	1; 0.9	0.694
SECONDARY Days of Invasive Ventilation	14.3; 13.3	0.97
SECONDARY Number of Infants Who Died	6; 1	0.60
SECONDARY Number of Abdominal Radiographs	4.34; 3.81	0.25
SECONDARY Episodes of Abdominal Distension	1.79; 0.590	0.001 sig
SECONDARY Emesis	2.46; 5.01	0.002 sig
SECONDARY Weight	1129.7; 1145	0.03 sig
SECONDARY Head Circumference	25.94; 25.85	0.56
SECONDARY Length	36.41; 36.78	0.59
SECONDARY Presence of Blood in Stools	0.247; 0.254	0.888
SECONDARY Level of Fecal Calprotectin	557.8; 456.1	0.694
SECONDARY Serum Gastrin Level	80.50; 92.29	0.248
SECONDARY Serum Motilin Level	228.5; 225.8	0.694
SECONDARY Fecal S100A12	195.2; 144.4	0.195

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01863043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.