Transpyloric Feeding in Severe Bronchopulmonary Dysplasia

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Brief Title

Transpyloric Feeding in Severe Bronchopulmonary Dysplasia

Official Title

Pilot N-of-1 Multiple Crossover Randomized Trial of Gastric and Transpyloric Feeds in Infants With Severe Bronchopulmonary Dysplasia

Brief Summary

      Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It
      impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with
      birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes including
      chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined
      as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks
      postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent
      episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the
      development of these impairments. Gastroesophageal reflux (GER) contributes to these
      mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately,
      clinically available methods to diagnose GER in infants are unreliable. Moreover, acid
      suppressive agents are both ineffective and carry high risk of serious life-threatening
      morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.

      This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway
      complications of GER and and whether this methodology can aid in identifying individual
      infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.

      Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to
      gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and
      improve a validated BPD severity score (secondary outcome).

      The investigators hypothesize that 80% percent of enrolled infants will have significantly
      fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and
      will have this feeding method formally recommended.

      Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared
      to gastric feeds reduce airway complications of GER in infants with severe BPD.

      The investigators hypothesize that transpyloric compared to gastric feeds will be associated
      overall with a 15% reduction in number of daily intermittent hypoxemic events.
    



Study Type

Interventional


Primary Outcome

Change in transient intermittent hypoxemic events every 4 days


Condition

Bronchopulmonary Dysplasia

Intervention

transpyloric feeding

Study Arms / Comparison Groups

 transpyloric tube feeds
Description:  Continuous transpyloric tube feeds administered through an oral/nasal feeding tube.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

15

Start Date

December 18, 2014

Completion Date

July 15, 2016

Primary Completion Date

July 15, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Gestational age ≤ 32 weeks

          -  Severe BPD (FiO2 ≥ 30% and/or mechanical ventilation or non-invasive positive pressure
             respiratory support at the time of enrollment)

          -  Post menstrual age of 36-45 6/7 weeks at enrollment

          -  Parent and/or guardian permission (informed consent)

        Exclusion Criteria:

          -  Prior intolerance to transpyloric feeds

          -  History of surgical anti-reflux procedure

          -  Congenital heart disease (not including patent ductus arterioles and hemodynamically
             insignificant ventricular septal defect or atrial septal defect)

          -  Structural abnormalities of the upper airway, lungs, or chest wall

          -  Other congenital malformations or syndromes that adversely affect life expectancy or
             cardio-pulmonary development

          -  Parent, guardian, or subject who, in the opinion of the investigators, are unlikely to
             participate for the duration of the study
      

Gender

All

Ages

N/A - 24 Weeks

Accepts Healthy Volunteers

No

Contacts

Haresh Kirpalani, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02142621

Organization ID

14-010924


Responsible Party

Sponsor

Study Sponsor

Children's Hospital of Philadelphia


Study Sponsor

Haresh Kirpalani, MD, Principal Investigator, Children's Hospital of Philadelphia


Verification Date

February 2018