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Completed

NCT Number: NCT01863043

Aspiration of Residual Gastric Contents

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.

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Nutrition, Enteral Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Gainesville, Florida, 32504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No aspiration of gastric contents

Procedure

Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Routine aspiration of gastric contents

Procedure

Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

Primary outcomes

  1. Enteral Intake on Day of Life 7

    Time frame: Day of life 7

    The volume in mL/kg of feeds provided to infant on day of life 7

  2. Enteral Intake on Day of Life 14

    Time frame: Day of life 14

    The volume in mL/kg of feeds provided to infant on day of life 7

  3. Enteral Intake on Day of Life 21

    Time frame: Day of life 21

    The volume in mL/kg of feeds provided to infants on day of life 21

  4. Enteral Intake on Day of Life 28

    Time frame: Day of life 28

    The volume in mL/kg of feeds provided to the infant on day of life 28

  5. Enteral Intake at Day of Life 35

    Time frame: Day of life 35

    The volume in mL/kg of feeds provided to infants on day of life 35

  6. Enteral Intake on Day of Life 42

    Time frame: Day of life 42

    The volume in mL/kg of feeds provided to infants on day of life 42

Secondary outcomes

  1. Days to Reach Full Feeds

    Time frame: baseline to approximately 42 days

    Full feeds is defined as 120 milliliters per kilogram per day

  2. Hours Receiving Parenteral Nutrition

    Time frame: Baseline to 42 days

    The number of hours participants required parenteral nutriton

  3. Hours of Central Line Access

    Time frame: Baseline to 42 days

    The number of hours participants required central line access

  4. Highest Alkaline Phosphatase Level

    Time frame: baseline to 42 days

    Highest level during the first 42 days

  5. Occurrence of Cholestasis

    Time frame: Baseline to 42 days

    Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL

  6. Level of Direct Bilirubin

    Time frame: Baseline to 42 days. highest value reported

    Level of direct bilirubin on routine weekly or biweekly laboratory testing

  7. Length of Hospital Stay

    Time frame: baseline to approximately 3 months

    Days infant remains in hospital

  8. Episodes of Late Onset Sepsis

    Time frame: 4 to 42 days

    Episodes of presumed or culture positive sepsis at > 3 days of life

  9. Episodes of Necrotizing Enterocolitis

    Time frame: Baseline to 42 days

    Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)

  10. Episodes of Ventilator Associated Pneumonia

    Time frame: baseline to 42 days

    Episodes of ventilator associated pneumonia

  11. Episodes of Aspiration Pneumonia

    Time frame: baseline to 42 days

    Episodes of aspiration pneumonia on radiograph

  12. Episodes of a Positive Tracheal Culture

    Time frame: Baseline to 42 days

    Episodes of a tracheal culture positive for bacteria

  13. Episodes of 2 or More Positive Tracheal Aspirate Cultures

    Time frame: Baseline to 42 days

    Episodes of 2 or more tracheal cultures positive for bacteria

  14. Episodes of Bronchopulmonary Dysplasia

    Time frame: Baseline to approximately 3 months

    Episodes of bronchopulmonary dysplasia

  15. Highest Tracheal Pepsin Level

    Time frame: Baseline to 42 days

    The highest level of pepsin obtained from endotracheal tube secretions

  16. Days of Invasive Ventilation

    Time frame: Baseline to approximately 3 months

    Number of days infants required invasive ventilation

  17. Number of Infants Who Died

    Time frame: Baseline to 42 days

    Number of infants who died during the 6 weeks study.

  18. Number of Abdominal Radiographs

    Time frame: baseline to 42 days

    number of abdominal radiographs performed

  19. Episodes of Abdominal Distension

    Time frame: Baseline to 42 days

    Episodes of increased abdominal girth by 2cm or greater

  20. Emesis

    Time frame: baseline to 42 days

    Number of emesis episodes

  21. Weight

    Time frame: 42 days

    Weight at 6 weeks of age. Note infants were born weighing < 1500 grams

  22. Head Circumference

    Time frame: 42 days

    Head circumference at 42 days

  23. Length

    Time frame: 42 days

    Length at 42 days

  24. Presence of Blood in Stools

    Time frame: baseline to 42 days

    Proportion of guaiac positive stools.

  25. Level of Fecal Calprotectin

    Time frame: 42 days

    Level of calprotectin in stools

  26. Serum Gastrin Level

    Time frame: baseline to 21 days

    level of gastrin at 3 weeks

  27. Serum Motilin Level

    Time frame: baseline to 21 days

    Serum motilin level at 21 days

  28. Fecal S100A12

    Time frame: 42 days

    Level of fecal S100A12

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
May 27, 2013
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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