Work of Breathing in Premature Infants at Discharge

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Bronchopulmonary dysplasia
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Brief Title

Work of Breathing in Premature Infants at Discharge

Official Title

Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge

Brief Summary

      The purpose of this study is to compare how premature infants who required oxygen for at
      least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at
      discharge compared to premature infants who did not require oxygen for at least 28 days
      during their time in the NICU.

Detailed Description

      Work of breathing tests will be performed on premature infants who required oxygen for at
      least 28 days during their time in NICU. These same work of breathing tests will be performed
      in another group of premature infants who did not require oxygen for at least 28 days during
      their time in the NICU. The two groups will be compared.

Study Type

Observational

Primary Outcome

Work of breathing indices

Secondary Outcome

 Intermittent Hypoxia

Condition

Bronchopulmonary Dysplasia

Intervention

Enrollment

Study Arms / Comparison Groups

 Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)
Description:  Preterm infants who were on oxygen at 28 days of life.

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

62

Start Date

November 10, 2020

Completion Date

July 31, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at
             birth.

          -  Infants with diagnosis of BPD and without diagnosis of BPD

        Exclusion Criteria:

          -  Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the
             accuracy of work of breathing measurements will be excluded.

Gender

All

Ages

1 Month - 7 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kelley Z Kovatis, MD, 302-733-2410, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03682575

Organization ID

DDD604122

Responsible Party

Sponsor

Study Sponsor

Christiana Care Health Services

Study Sponsor

Kelley Z Kovatis, MD, Principal Investigator, ChristianaCare

Verification Date

August 2021