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Transpyloric Feeding for Prevention of Micro-aspiration

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ClinicalTrials.gov Identifier: NCT03646045
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
Nemours Biomedical Research
Information provided by (Responsible Party):
Nemours Children's Clinic

Brief Summary:
To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.

Condition or disease Intervention/treatment
Microaspiration Gastro Esophageal Reflux Other: Transpyloric feeding

Detailed Description:

Specific Aim 1): To determine the effect of TP feeding on microaspiration and lung inflammation. Hypothesis: TP feeding will reduce the microaspiration and pulmonary inflammation in ventilated preterm infants. Evaluate markers of microaspiration (pepsin A) and lung inflammation [total cell counts, nuclear factor-kB (NF-kB) activation, tumor necrosis factor-α (TNF-α), IL-1β, IL-6, IL-8, angiopoietin 2 (Ang2), high-mobility group box-1 protein (HMGB1), macrophage migration inhibitory factor (MIF) and interferon-γ (IFN-γ)] in TA samples obtained from preterm ventilated infants with and without TP feeding.

Specific Aim 2): To determine the effect of TP feeding on respiratory support. Hypothesis: TP feeding will decrease the respiratory severity score (RSS) [Fraction of inspired oxygen (FiO2) X mean airway pressure (MAP)] and number of infants requiring ventilator support. Evaluate respiratory support in preterm ventilated infants with and without TP feeding.


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Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Transpyloric Feeding for Prevention of Micro-aspiration
Actual Study Start Date : November 4, 2016
Estimated Primary Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
Transpyloric feed
Preterm infant receiving transpyloric feeding.
Other: Transpyloric feeding
Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)

Control
Preterm infants receiving gastric feeding



Primary Outcome Measures :
  1. Tracheal aspirate pepsin A levels in ventilated preterm infants receiving transpyloric feeding and gastric feeding. [ Time Frame: 3-7 days ]
    Difference in tracheal aspirate pepsin A levels in preterm ventilated infants receiving transpyloric feeding and gastric feeding.


Secondary Outcome Measures :
  1. Tracheal aspirate pepsin A levels in ventilated preterm infants before and after transpyloric feeding. [ Time Frame: 3-7 days ]
    Change in tracheal aspirate pepsin A levels in preterm ventilated infants before and after transpyloric feeding.

  2. Tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in ventilated preterm infants receiving transpyloric feeding and gastric feeding. [ Time Frame: 3-7 days. ]
    Difference in tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

  3. Tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in ventilated preterm infants before and after transpyloric feeding. [ Time Frame: 3-7 days ]
    Change in tracheal aspirate cytokines levels (TNF-α, IL-1β, IL-6, IL-8, Ang2, HMGB1, MIF and IFN-gamma) in preterm ventilated infants before and after transpyloric feeding.

  4. Respiratory support in ventilated preterm infants receiving transpyloric feeding and gastric feeding. [ Time Frame: 7-14 days ]
    Difference in respiratory severity score (FiO2 X mean airway pressure) in preterm ventilated infants receiving transpyloric feeding and gastric feeding.

  5. Respiratory support in ventilated preterm infants before and transpyloric feeding. [ Time Frame: 7-14 days ]
    Change in respiratory severity score (FiO2 X mean airway pressure) in preterm ventilated infants before and after transpyloric feeding.


Biospecimen Retention:   Samples Without DNA
Tracheal aspirate samples


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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants (birth weight <1500 grams) requiring ventilator support.
Criteria

Inclusion Criteria:

  • Preterm infants with birth weight <1500 grams
  • Requiring ventilatory support

Exclusion Criteria:

  • Culture-proven sepsis
  • Ventilator associated pneumonia (VAP).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646045


Contacts
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Contact: Zubair Aghai, MD zubair.aghai@nemours.org

Locations
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United States, Delaware
AI duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Zubair Aghai, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Zubair Aghai, MD       zaghai@nemours.org   
Sponsors and Collaborators
Nemours Children's Clinic
Nemours Biomedical Research
Investigators
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Principal Investigator: Zubair H Aghai, MD Nemours

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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03646045     History of Changes
Other Study ID Numbers: 741563-9
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases